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CDR-Life Announces Pipeline Progress of M-gager® Programs for Treatment of Solid Tumors

September 13, 2024

 CDR404 and CDR813: First-of-its-kind antibody-based T cell engagers targeting intracellular tumor antigens MAGE-A4 and PRAME via the major histocompatibility complex

First patient treated with MAGE-A4-targeting CDR404; presentation at ESMO showcases potential of PRAME-targeting CDR813 to exhibit best-in-class characteristics in the clinic

Zürich, Switzerland, September 13, 2024 – CDR-Life today announced significant clinical progress in its M-gager® portfolio for solid tumors, marking important milestones in the company’s mission to deliver innovative, antibody-fragment based immunotherapies for difficult-to-treat cancers.

First patient dosed with CDR404
The first patient was dosed with CDR404, a novel, bispecific and bivalent antibody fragment-based T cell engager (TCE) targeting MAGE-A4, an intracellular cancer-specific protein that is cleaved into smaller peptide fragments and presented on HLA-A*02:01 molecules at the surface of cancer cells.

The Phase 1 study (NCT06402201) is enrolling HLA-A *02:01+ patients with MAGE-A4+ solid cancers in the U.S. and Europe. The trial is evaluating the safety, tolerability and preliminary anti-tumor activity of CDR404 in several common cancers including squamous cell carcinomas in which MAGE-A4 is highly enriched.

New clinical candidate targeting PRAME
Preferentially Expressed Antigen in Melanoma (PRAME) is a tumor-specific therapeutic target that is expressed in a wide range of solid tumors including lung, ovarian, melanoma, and endometrial cancers, while exhibiting only minimal expression in healthy tissues.

CDR-Life has identified and characterized an antibody fragment-based TCE as a clinical candidate targeting PRAME called CDR813. This TCE binds potently and bivalently to an HLA-A02-restricted PRAME peptide on the surface of cancer cells. Pre-clinical studies have shown that CDR813 has very favorable pharmacological and manufacturability properties with best-in-class potential for the clinic.

A poster will be presented at the 2024 European Society for Medical Oncology (ESMO) Congress, in Barcelona, Spain.

Poster Presentation Details
Title: Highly potent and specific bivalent T cell engager (TCE) targeting PRAME on HLA-A02:01
Date and Time: Saturday, September 14, 2024, 12 – 1 pm CET
Abstract Number: 5132, Poster 1020P

“The clinical advancement of CDR404 and the excellent progress we have made in advancing CDR813 into a clinically viable drug are significant milestones in our quest to develop life-changing, antibody fragment-based cancer medicines for patients with the HLA-A*02:01 genotype, the most prevalent HLA genotype in the U.S. and Europe, using our proprietary M-gager technology,” said Swethajit Biswas, Chief Medical Officer of CDR-Life. “This current suite of T cell engagers targeting cancer-specific peptides presented on HLA underscores our ambitions in solid tumor oncology to create an innovative pipeline of highly specific and potent antibody fragment-based molecules targeting a wide range of cancer-specific antigens including challenging cell surface resident proteins, which are known to be directly involved in tumor growth.”

About CDR-Life
CDR-Life develops highly targeted T cell engagers (TCEs) for the treatment of solid cancers and autoimmune diseases. Our M-gager® platform delivers TCEs against challenging but cancer-specific intracellular and surface antigens through unparalleled target-specificity. We are advancing a pipeline of potent and selective TCE therapeutics. Our partnership with Boehringer Ingelheim on a molecule derived from our M-gager® platform, progressing to Phase 2 trials, demonstrates the potential of our antibody-derived molecules. Backed by leading cross-Atlantic investors, our team is committed to bringing life-changing, disease-modifying medicines to patients globally. Learn more at www.cdr-life.com.

Contacts

Media:
Lauren Arnold
LA Communications
Lauren@LACommunications.net

Investors:
Christian Leisner, CEO
CDR-Life Inc.
Christian.leisner@cdr-life.com

Boehringer Ingelheim announces plans to advance potential new treatment for Geographic Atrophy, following positive Phase I results

September 5, 2024

Ingelheim, Germany and Basel, Switzerland, September 5, 2024 – Boehringer Ingelheim and CDR-Life today announce positive results from the Phase I evaluation of BI 771716 (Study Record | ClinicalTrials.gov), an investigational antibody fragment developed to preserve vision in people living with geographic atrophy (GA). BI 771716 met its primary safety endpoint following intravitreal administration of single and multiple doses. Preparation for the Phase II trial is now underway, with an expected start date in early 2025.

GA is an advanced and severe form of late-stage, dry age-related macular degeneration (AMD), a chronic and progressive retinal disease, that can lead to irreversible and permanent vision loss.1 It is a leading cause of blindness, affecting more than five million people worldwide, of which more than 40% are considered blind.1-3 Vision loss associated with GA severely impacts the independence, mental health and quality of life of those living with the condition.4 Current treatments have limited efficacy and availability.

BI 771716, developed by Boehringer Ingelheim with technology licensed from CDR-Life, is a highly specific antibody fragment, possibly enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology. Based on its molecular properties, BI 771716 has the potential to achieve unprecedented efficacy.

“We are delighted to have achieved a critical milestone in our development of BI 771716, and are now preparing a Phase II clinical study to investigate efficacy and dosing,” said Heiko Niessen, Ph.D., Global Therapeutic Area Head Translational Medicine & Clinical Pharmacology Retinal Health at Boehringer Ingelheim. “BI 771716 is part of our comprehensive retinal portfolio demonstrating our long-term commitment to preserving both eyesight and quality of life in people with retinal diseases.”

“Reaching this safety milestone is a significant step forward for this compound, highlighting the strength of our partnership with Boehringer Ingelheim,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “Having successfully met all four planned milestones so far, we’re optimistic about the continued development of this innovative antibody fragment-based therapy and its potential to provide clinical benefit in geographic atrophy.”

“The development of new therapies for geographic atrophy remains one of the most important needs in the age related macular degeneration space,” said Charles C. Wykoff, MD, Ph.D., Principal Investigator of the Phase I trial, Director of Research at Retina Consultants of Texas; Chair of Research, Retina Consultants of America; and Deputy Chair of Ophthalmology for the Blanton Eye Institute, Houston Methodist Hospital. “Achieving the Phase I safety

endpoint is a meaningful step forward for this potential new treatment for people with this sight-threatening and life-affecting condition.”

CDR-Life and Boehringer Ingelheim announced their collaboration and licensing agreement in May 2020, followed by the selection of an antibody fragment-based therapeutic candidate in September 2021. The companies have executed on all milestones to date.

Notes to Editors:

About the trial (NCT06006585) Study Record | ClinicalTrials.gov

The Phase I trial measured the safety, tolerability, and pharmacokinetics of intravitreal single rising doses and multiple doses of BI 771716 in patients with geographic atrophy aged 50+. The purpose of the study was to determine how well different doses of BI 771716 are tolerated.

This study had two parts.  

Participants received one injection of BI 771716 directly into one of the eyes affected by geographic atrophy. The primary endpoint was the number of patients with ocular dose-limiting events (DLEs) from drug administration until Day 8; secondary endpoints included occurrence of any ocular adverse events (AEs) and maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax).

Single rising dose (SRD)

Participants received one injection of BI 771716 directly into one of the eyes affected by geographic atrophy. The primary endpoint was the number of patients with ocular dose-limiting events (DLEs) from drug administration until Day 8; secondary endpoints included occurrence of any ocular adverse events (AEs) and maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax).

Multiple dose (MD)

Participants received two injections of BI 771716 directly into the eye. There were 4 weeks between the first and the second injection.

Detailed study results will be made available in the coming months.

About BI 771716

BI 771716, developed by Boehringer Ingelheim with technology licensed from CDR-Life, is a highly specific antibody fragment, enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology. BI 771716 is part of Boehringer Ingelheim’s research and development portfolio in retinal conditions.

About Geographic Atrophy (AMD)

AMD is an age-related disease of the central portion of the retina (the macula) which is responsible for high visual acuity that allows for color vision, reading and facial recognition.4 Geographic atrophy (GA) is an advanced and severe form of AMD that progresses slowly but can lead to permanent vision loss.4 More than 5 million people worldwide suffer from GA, of which more than 40% are legally blind.1-3 From age 50 years, the prevalence of GA quadruples every 10 years.5 Consequently, rising incidences are expected in aging populations.

People with GA experience moderate to severe central vision loss, which can impact daily life activities such as driving, shopping alone, reading, finding street signs and a wide range of social and manual activities that require fine motor control.4 These limitations can lead to a loss of independence and social isolation, which in turn can have an impact on mental health, leading to depression, fear and anxiety.4

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com.

About CDR-Life

CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors.

Boehringer Ingelheim’s Intended Audiences Notice

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

References

  1. Rahimy E, et al. Progression of Geographic Atrophy: Retrospective Analysis of Patients from the IRIS® Registry (Intelligent Research in Sight). Ophthalmol Sci. 2023 Apr 19;3(4):100318.
  2. Wong WL, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.
  3. Colijn JM et al. Enlargement of Geographic Atrophy From First Diagnosis to End of Life. JAMA Ophthalmol. 2021;139(7):743-750
  4. Sacconi R, et al. A Review of Current and Future Management of Geographic Atrophy. Ophthalmol Ther 2017;6:69-77.
  5. Rudnicka AR, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta-analysis. Ophthalmology. 2012 Mar;119(3):571-80

Media Contacts

Dr. Reinhard Malin
Boehringer Ingelheim
Corporate Affairs

press@boehringer-ingelheim.com

CDR-Life:
Lauren Arnold
LA Communications
Lauren@LACommunications.net

CDR-Life Announces Pipeline Expansion of Highly Tumor-Targeted T Cell Engagers 

June 25, 2024

 CDR813 and CDR505 programs further broaden pipeline of cancer-specific targeted therapies 

 Zürich, Switzerland, June 25, 2024 – CDR-Life Inc. today announced an expansion of its pipeline of novel T cell engagers (TCE) with the addition of CDR813 and CDR505.

CDR813 is a highly potent and selective TCE candidate targeting tumors expressing PRAME (preferentially expressed antigen in melanoma) in HLA-A*2:01 patients. PRAME is a clinically validated pan-cancer target expressed in a broad set of tumors including non-small cell lung cancer (NSCLC), endometrial cancer, melanoma and ovarian cancer, but not in normal tissue. A bi-valent and bi-specific antibody-based TCE, CDR813 targets a PRAME peptide presented on tumor cells by the HLA-A*02 complex and the CD3 receptor on T-cells with unparalleled potency and specificity.

CDR505 is a TCE targeting KK-LC-1, a novel HLA-A*01 target relevant in common cancer populations not yet addressed by other T cell receptor (TCR) therapeutics. While most TCE programs target the HLA-A02 haplotype, CDR505 targets KK-LC-1/HLA-A*01, expanding the potential of TCEs to benefit a large patient population with high unmet need. Preclinical data on CDR505 was presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2024.

“With our continued investment in building a broad pipeline of unique, potent and highly cancer- targeted therapies, we are expanding the promise of our differentiated T cell engager platform to treat a range of solid tumors,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “Importantly, the CDR813 and CDR505 programs are geared toward populations with significant unmet medical need, increasing our reach to benefit more patients.”

About CDR-Life

CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors. 

Contacts

Media:
Lauren Arnold
LA Communications
Lauren@lacommunications.net

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CDR-Life Announces Initiation of CDR404 Phase 1 Trial for Treatment of Solid Tumors at ASCO

May 29, 2024

Zürich, Switzerland, May 29, 2024 – CDR-Life Inc. today announced the initiation of enrollment for the Phase 1 trial of CDR404, its lead program in development as a precision immunotherapy for solid tumors. CDR404 will be the focus of an abstract accepted for online presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, occurring May 31 – June 4 in Chicago, Illinois.

Based on the company’s unique M-gager® technology, CDR404 is a first-of-its-kind, antibody-based bivalent and bispecific MAGE-A4 T-cell engager (TCE) for the treatment of MAGE-A4 positive solid tumors. The Phase I study evaluating CDR404 is actively enrolling at sites in the U.S. and Europe. To learn more, visit clinicaltrials.gov (NCT06402201).

“We are thrilled at the progress being made following the clearance of an Investigational New Drug (IND) application with the U.S. FDA for CDR404 at the start of this year as well as subsequent approval of the Clinical Trial Application (CTA) in Denmark, and look forward to continuing this momentum,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “This milestone brings us one step closer to our goal of delivering a better off-the-shelf therapy for cancer patients in need.”

The ASCO abstract presents findings from a study that assessed the biomarkers responsible for predicting the effectiveness of CDR404 in fighting non-small cell lung cancer (NSCLC) tumors.

About CDR-Life

CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors.

Contacts

Media:
Lauren Arnold
MacDougall Advisors
LArnold@macdougall.bio

CDR-Life to Present at 6th Annual Cell Engager Summit

May 21, 2024

Zürich, Switzerland, May 15, 2024 – CDR-Life Inc. today announced that Chief Medical Officer Swethajit Biswas, MD, FRCP, will co-lead a seminar at the 6th Annual Cell Engager Summit, occurring May 21-23 in Boston. 

The seminar, “Back-Tracking Breakthroughs for BITEs & Cell Engagers to Gain Reverse Translation Insights” will be co-led with Dr. Anthony Stein, MD, of City of Hope, and will delve into the practical implications of post-approval studies, shedding light on the long-term safety and efficacy of cell engager drugs. By analyzing real-world data, researchers will gain valuable insights into overcoming the limitations of animal models and better replicating systemic immune responses in patients. The seminar aims to foster actionable lessons for improving safety profiles and advancing the field of cell engager therapies. Details of the workshop include: 

  • Perspectives from clinical development leaders and oncologists treating a range of patient populations 
  • Exploring evidence of disease progression and potential immune escape or resistance mechanisms
  • Uncovering the long-term effects and exploring future avenues for combination therapies 

The seminar will be held on Tuesday, May 21 at 1:00pm ET.

“Novel cell engager therapies have immense potential to change the way we treat a variety of serious cancers, and I look forward to discussing essential considerations for the development of these therapies with Dr. Stein,” said Dr. Biswas. “By reviewing real-world insights in diverse patient populations and clinical scenarios, we can identify the most promising opportunities for the development of next-generation cell engagers.”

CDR-Life’s proprietary M-gager® platform is designed to develop highly specific and effective peptide-MHC (pMHC)-targeting T cell engagers. M-gager® molecules are expected to be highly effective immunotherapies for challenging targets with high unmet medical need, such as neoantigens and cancer testis antigens (CTA), providing minimal off-tumor activity.

About CDR-Life

CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors. 

Contacts

Media:
Lauren Arnold
MacDougall Advisors
LArnold@macdougall.bio

CDR-Life Announces Fourth Milestone Achievement with Boehringer Ingelheim in Phase 1 Geographic Atrophy Trial

April 30, 2024

Zürich, Switzerland, April 30, 2024 – CDR-Life Inc. today announced the advancement of the Phase 1 study with BI 771716, its therapeutic candidate in partnership with Boehringer Ingelheim (BI) for the treatment of geographic atrophy (GA). This marks the achievement of the fourth milestone under the collaboration and licensing agreement between BI and CDR-Life. 

BI 771716 is an antibody fragment-based compound. Its reduced size enables optimized retinal layer-penetration to the most critical target site driving GA disease pathology.

“We are thrilled by the continued success of our long-term partnership with Boehringer Ingelheim and the progression of BI 771716 in this Phase 1 trial as evident by the achievement of this fourth milestone payment,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “Together with Boehringer Ingelheim, we are hopeful that this candidate has the potential to significantly slow down the progression of GA, bringing a much-needed treatment option to the millions of patients who are living with this devasting disease.” 

CDR-Life and BI announced the collaboration and licensing agreement in May 2020, followed by the selection of an antibody fragment-based therapeutic candidate in September 2021. The companies have executed on all milestones to date. 

About Geographic Atrophy (GA)

GA is a chronic and progressive, irreversible retinal disease that occurs in people with late-stage dry age-related macular degeneration (AMD) impacting the ability to see. More than 5 million people worldwide suffer from GA, of which more than 40% are legally blind. GA worsens with age, affecting 1 in 29 people above the age of 75 and 1 in 4 people above 90. Consequently, rising incidences are expected in aging populations.

About CDR-Life

CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors. 

Contacts

Media: 

Lauren Arnold 

MacDougall Advisors 

LArnold@macdougall.bio

CDR-Life to Present Tumor Targeting Capabilities of M-gager® Platform at the TCR-Based Therapies for Solid Tumors Summit

April 23, 2024

Zürich, Switzerland, April 23, 2024 – CDR-Life Inc. today announced a presentation on its proprietary antibody-major histocompatibility complex (MHC) technology for the development of highly specific T-cell engagers (TCE) at the TCR-Based Therapies for Solid Tumors Summit, occurring April 23-25 in Boston, Massachusetts. 

The presentation will discuss how antibodies targeting tumor peptides on the MHC enable T-cells access to an untapped reservoir of intracellular tumor antigens and will highlight the M-gager® technology’s ability to leverage the potency, versatility and manufacturability of antibodies to revolutionize cancer immunotherapy. 

Presentation Details

Title: Unlocking Tumor Eradication with Antibody-MHC T Cell Engagers  

Presenter: Leonardo Borras, Chief Scientific Officer 

Date: April 23, 2024


About CDR-Life

CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors. 

Contacts

Media:
Holly Hancock
MacDougall Advisors
hhancock@macdougall.bio

CDR-Life Unveils Results on T-Cell Engagers Targeting Hard-to-Treat Solid Tumors at AACR 2024 

April 5, 2024

 Preclinical data shows promising anti-tumor activity and specificity for
KK-LC-1/HLA-A*01 positive tumors 

 Zürich, Switzerland, April 5, 2024 – CDR-Life Inc. today announced the presentation of preclinical data demonstrating the promising anti-tumor properties of its peptide major histocompatibility complex (pMHC) T-cell engager (TCE) antibodies at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place this week in San Diego, California. 

The Kita-Kyushu lung cancer antigen-1 (KK-LC-1/CT83) is a promising target because it is not expressed in normal tissues and is highly prevalent across a broad range of cancers including gastric, lung, breast and cervical cancer. Identifying a TCE against the KK-LC-1 peptide on HLA-A*01 will provide an option for patients that do not benefit from the more common HLA-A*02 targeting therapeutics currently in development. However, high levels of similar off-target peptides presented in healthy tissues make targeting the KK-LC-1/HLA-A*01 challenging. 

CDR-Life’s data gathered on pMHC TCE antibodies with high specificity towards HLA-A*01 restricted KK-LC-1 epitopes demonstrate the antibodies’ promising anti-tumor activity and specificity for KK-LC-1/HLA-A*01 positive tumors. 

“While there is a growing number of agents targeting pMHCs, most of them are restricted to 

HLA-A*02, underscoring the need to identify effective pMHC targeted therapies for solid tumors on other alleles to reach a greater number of patients,” said Swethajit Biswas, M.D., Ph.D., Chief Medical Officer at CDR-Life. “We are excited about the progress we have made with our TCE platform in hard-to-treat solid tumors and look forward to sharing additional insights for the benefit of this patient population.” 

Key Findings: 

  • The evaluated TCEs demonstrated potent killing of KK-LC-1/HLA-A*01-positive cancer cells. 
  • The data showed no evidence for off-target cytotoxic activity towards KK-LC-1-negative/ HLA-A*01-positive healthy human cells. 
  • In vitro studies showed significantly higher TCE-dependent T-cell activation towards cells presenting the target peptide compared to the risk peptides. 
  • Characterization of the TCE peptide recognition shows a very specific binding profile. 

Presentation Overview: 

Title: Novel antibodies against a KK-LC-1-derived peptide presented on HLA-A*01 on tumor cells Date and Time: Wednesday Apr 10, 2024, 9:00 AM – 12:30 PM PT 

Location: Poster Section 54 Poster Number: 18 

About CDR-Life

CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors. 

Contacts

Media:
Holly Hancock
MacDougall Advisors
hhancock@macdougall.bio

CDR-Life Announces FDA Clearance of IND Application for CDR404 for Treatment of Solid Tumors

January 23, 2024

First-of-its-kind, antibody-based, bivalent and bispecific MAGE-A4 T-cell engager

Zürich, Switzerland, January 23, 2024 – CDR-Life Inc. today announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CDR404, its lead program in development as a precision immunotherapy for solid tumors.

First of its kind, CDR404 is an antibody-based, bivalent and bispecific MAGE-A4 T-cell engager (TCE) based on the company’s unique M-gager® technology for targeting intracellular tumor antigens through the major histocompatibility complex (MHC).

“CDR404 holds the potential to become the off-the-shelf therapy for multiple cancers expressing MAGE-A4 with high unmet need, including non-small cell lung cancer (NSCLC),” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “We are thrilled to achieve this milestone and are continuing to advance several additional programs leveraging our M-gager® technology against promising intracellular cancer targets with the goal of improving patient lives.” 

The company anticipates initiating Phase 1 trial enrollment in the coming months. 

About CDR-Life

CDR-Life is developing highly specific antibody therapeutics to target intracellular proteins presented on the major histocompatibility complex (MHC). Our versatile MHC-targeted antibody platform increases access to a vast array of antigens that were not previously addressable, to develop a pipeline of first in class therapeutics across a broad range of solid tumors. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to redirect and activate the patient’s own immune system to eliminate their tumors.

Contacts

Media:
Holly Hancock
MacDougall Advisors
hhancock@macdougall.bio

CDR-Life Announces First Patient Dosed in Phase 1 Study with Boehringer Ingelheim Evaluating Potential Treatment for Geographic Atrophy

December 6, 2023

Licensed to Boehringer Ingelheim, BI 771716 is a highly specific antibody fragment of reduced size, enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology.

Zürich, Switzerland, December 6, 2023 – CDR-Life Inc. today announced that the first patient has been dosed in the Phase 1 trial of BI 771716 for the treatment of geographic atrophy (GA). Licensed to Boehringer Ingelheim, BI 771716 is a highly specific antibody fragment of reduced size, enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology.

The Phase 1 study (NCT06006585) is evaluating the safety, tolerability and pharmacokinetics of intravitreal single rising doses and multiple doses of BI 771716 as a potential treatment for GA.

GA is a chronic and progressive, irreversible retinal disease that occurs in people with late-stage dry age-related macular degeneration (AMD) impacting the ability to see. More than 5 million people worldwide suffer from GA, of which more than 40% are legally blind. GA worsens with age, affecting 1 in 29 people above the age of 75 and 1 in 4 people above 90. Consequently, rising incidences are expected in aging populations.

“This milestone marks CDR-Life’s emergence as a clinical stage company and underscores the ability of our platform to generate molecules that may one day bring life changing treatments to patients,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “We look forward to the continued development of BI 771716 as it progresses through the clinic.”

About CDR-Life

CDR-Life is developing highly specific antibody therapeutics to target intracellular proteins presented on the major histocompatibility complex (MHC). Our versatile MHC-targeted antibody platform increases access to a vast array of antigens that were not previously addressable, to develop a pipeline of first in class therapeutics across a broad range of solid tumors. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to redirect and activate the patient’s own immune system to eliminate their tumors.

Contacts
Media:
Holly Hancock
MacDougall Advisors
hhancock@macdougall.bio

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CDR-Life Presents Findings from Two Studies in Preparation of Phase 1 Trial with Immunotherapy CDR404 for Treatment of Solid Tumors at SITC 2023 

November 3, 2023

Therapeutic potential of CDR404, as a first-of-its-kind precision immunotherapy for HLA-A*02:01+ patients with MAGE-A4+ squamous non-small cell lung carcinoma (SQ-NSCLC)
Development of a Quantitative Systems Pharmacology (QSP) model to facilitate discovery of safe and efficacious doses for upcoming Phase 1 trial

in the run-up to initiation of its first Phase 1 clinical trial, presented two posters for CDR404, a first-of-its-kind, antibody-based, bivalent & bispecific MAGE-A4 T-cell engager (TCE) targeting MAGE-A4, an intracellular cancer protein with expression in several frequent and difficult to treat solid tumors, at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting.

“The absence of actionable genetic alterations makes SQ-NSCLC a difficult-to-treat cancer after relapse from immune checkpoint blockade. The demonstration of high MAGE-A4 protein expression in SQ-NSCLC and potent preclinical cytotoxicity of CDR404, highlights the therapeutic promise of CDR404 in HLA-A*02:01+ patients with SQ-NSCLC. Results from the second presentation show that leveraging the QSP model for the prediction of CDR404 doses that are likely to be safe and efficacious will enable CDR-Life to select the most effective dose to carry forward into a future registrational study,” said Swethajit Biswas, M.D., Ph.D., Chief Medical Officer at CDR-Life.

“These milestones underscore the continued advancement of CDR404’s potential as an off-the-shelf precision immunotherapy for MAGE-A4+ solid tumors. The unique Fab-(scFv)2 molecular format and CD3 binding properties of CDR404 is very different compared to previous T-cell engagers which have targeted MAGE-A4+ tumors, thereby optimizing the probability-of-success in the clinic,” Dr. Biswas concluded.

Poster presentation highlights include:

Abstract 1397

  • SQ-NSCLC had the highest MAGE-A4 mRNA expression levels among solid cancers in the TCGA database.
  • Immunohistochemistry showed positive MAGE-A4 staining in 28/50 SQ-NSCLC samples.
  • Treatment with four different doses of CDR404 induced complete tumor regression in the in vivo SQ-NSCLC NCI-H1703 xenograft model.

Abstract 195

  • The QSP model builds a preliminary understanding of the relationship between MAGE-A4 expression and intra-tumor T-cell density in determining CDR404 anti-tumor activity.
  • The QSP model predicted doses of CDR404 which might have the most favorable benefit-risk profile for patients in the Phase 1 trial

“The tumor and patient selection findings presented at ESMO mark an important milestone in the development of CDR404 as a potential off-the-shelf precision immunotherapy for solid tumors,” said Swethajit Biswas, M.D., Ph.D., Chief Medical Officer at CDR-Life. “We look forward to the continued progress of our innovative CDR404 T-cell engager program as we near the initiation of our Phase 1 trial, anticipated to begin in 2024.”

Poster Presentation Details:

Title: CDR404, an antibody-based bispecific & bivalent T-cell engager targeted against MAGE-A4, for Squamous Non-Small Cell Lung Cancer (SQ-NSCLC)
Abstract Number: 1397
Presentation Date: Friday, November 3, 2023
Presentation Time: 12:00 p.m. – 1:30 p.m. PDT

Title: Overcoming the dose-response prediction limitation from bench to clinic for T-cell engagers: Using Quantitative Systems Pharmacology (QSP) modeling in the development of CDR404 for solid tumors
Abstract Number: 195
Presentation Date: Friday, November 3, 2023
Presentation Time: 12:00 p.m. – 1:30 p.m. PDT

About CDR-Life

CDR-Life is developing highly specific antibody therapeutics to target intracellular proteins presented on the major histocompatibility complex (MHC). Our versatile MHC-targeted antibody platform increases access to a vast array of antigens that were not previously addressable, to develop a pipeline of first in class therapeutics across a broad range of solid tumors. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to redirect and activate the patient’s own immune system to eliminate their tumors.

Contacts
Media:
Holly Hancock
MacDougall Advisors
hhancock@macdougall.bio

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CDR-Life Presents Precise Tumor and Patient Selection for CDR404: First-of-its-Kind Dual MAGE-A4 T-cell Engager, at ESMO Congress 2023 

October 23, 2023

CDR404 represents a potential paradigm shift in the development of T-cell engagers for solid cancers Epithelial cancer indications eligible for CDR404 Phase 1 trial include non-small cell lung carcinoma (NSCLC), head & neck squamous cell carcinoma and bladder cancer

Zürich, Switzerland, October 23, 2023 – CDR-Life Inc. presented findings on tumor target expression and precise patient selection for the upcoming Phase 1 trial of CDR404 (Abstract 200P), a first-of-its-kind bispecific and bivalent antibody fragment-based T-cell engager (TCE) targeting MAGE-A4, an intracellular protein which is presented on HLA-A*02:01 on the surface of cancer cells, at the ESMO Congress 2023, occurring October 20-24 in Madrid, Spain.

The key objective of this study was for CDR-Life to explore MAGE-A4 expression levels in solid tumors using The Cancer Genome Atlas (TCGA) mRNA dataset.

TCGA bioinformatic analyses revealed that squamous cell cancers were enriched for high levels of MAGE-A4 mRNA expression including squamous NSCLC, head and neck carcinoma associated with absence of human papillomavirus (HPV) infection, and bladder cancer. In addition, subgroups of high MAGE-A4 expression were present across a wide range of solid cancers including lung adenocarcinoma, ovarian and gastric cancers. In lung adenocarcinoma, the study has also shown preliminary evidence for a potentially discrete molecular sub-group of high MAGE-A4 tumors which might benefit from CDR404 treatment.

“CDR404 is a novel, bispecific and bivalent T-cell engager differentiated from previous solid tumor T-cell engagers targeting MAGE-A4 in the clinic. This study demonstrates that there are subgroups of high MAGE-A4 expression present across a wide range of solid cancers,” said Emiliano Calvo, M.D., Ph.D., Director of START Madrid, Spain and Senior Investigator for the Phase 1 trial. “Since HLA-A*02:01 is the most prevalent HLA allele across the USA and Europe, this indicates the potential for multiple future therapeutic opportunities for CDR404 especially in patients with MAGE-A4+ tumors who cannot be effectively treated with immune checkpoint blockades.”

Key takeaways:

  • High levels of MAGE-A4 expression are present in different sized sub-groups across a wide range of solid cancers with high unmet medical need including NSCLC (squamous and adenocarcinoma histology), head and neck squamous cell carcinoma, gynecological and bladder cancers.
  • The MAGE-A4 mRNA distribution profiles across multiple tumor types indicates that a tumor MAGE-A4 assay will be indispensable for trial screening. CDR-Life has identified a highly specific MAGE-A4 immunohistochemistry (IHC) antibody for this purpose.
  • Time to detection of efficacy signals in the Phase 1 trial can be optimized by prioritizing recruitment of patients with tumor types that have high median MAGE-A4 expression such as squamous lung, head and neck and bladder cancers

“The tumor and patient selection findings presented at ESMO mark an important milestone in the development of CDR404 as a potential off-the-shelf precision immunotherapy for solid tumors,” said Swethajit Biswas, M.D., Ph.D., Chief Medical Officer at CDR-Life. “We look forward to the continued progress of our innovative CDR404 T-cell engager program as we near the initiation of our Phase 1 trial, anticipated to begin in 2024.”

Poster Presentation Details:

Title: Precise Tumor & Patient Selection for CDR404: A Bispecific & Bivalent MAGE-A4 T-Cell Engager

Abstract Number: 200P

Presentation Date: Saturday, October 21, 2023

Presentation Time: 1:00 p.m. CET

About CDR-Life

CDR-Life is developing highly specific antibody therapeutics to target intracellular proteins presented on the major histocompatibility complex (MHC). Our versatile MHC-targeted antibody platform increases access to a vast array of antigens that were not previously addressable, to develop a pipeline of first in class therapeutics across a broad range of solid tumors. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to redirect and activate the patient’s own immune system to eliminate their tumors. 

Contacts
Media:
Holly Hancock
MacDougall Advisors
hhancock@macdougall.bio

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Boehringer Ingelheim to start phase 1 development of BI 771716 – a potential new treatment for Geographic Atrophy, a leading cause of blindness worldwide

October 2, 2023

Ingelheim Germany and Basel, Switzerland, 2 October 2023 – Boehringer Ingelheim and CDR-Life announce the initiation of the Phase 1 evaluation of BI 771716 (Study Record | ClinicalTrials.gov), an antibody fragment-based treatment developed to preserve vision of people living with geographic atrophy (GA).

GA is a chronic and progressive, irreversible retinal disease that occurs in people with late-stage dry age-related macular degeneration (AMD) impacting the ability to see. More than 5 million people worldwide[1] suffer from GA, of which more than 40% are legally blind. GA worsens with age, affecting 1 in 29 people above the age of 75 and 1 in 4 people above 90. Consequently, rising incidences are expected in aging populations.

BI 771716, developed with technology licensed from CDR-Life, is a highly specific antibody fragment of reduced size, enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology. Based on its molecular properties, BI 771716 has the potential to achieve unprecedented efficacy.

“We are very pleased to start the clinical evaluation of BI 771716, which resulted from collaborative efforts with CDR-Life,” said Clive R. Wood, Corporate Senior Vice President and Global Head of Discovery Research at Boehringer Ingelheim. “This brings us another step closer to achieving our vision of developing precise treatments to stop vision loss, protecting and preserving both people’s eyesight and quality of life.”

“We are delighted to see this compound progress into the clinic,” said Christian Leisner, Chief Executive Officer at CDR-Life. “We are looking forward to BI 771716 potentially becoming a treatment to transform the lives of people living with GA.”

Over the past decade Boehringer Ingelheim has built a strong and diverse retinal health pipeline, which focuses on three priority areas: The preservation of vascular function, targeting inflammation and neuroprotection. Core disease areas are AMD (from intermediate to neovascular AMD and GA), diabetes-related retinal diseases (Diabetic Retinopathy with its complications including oedema and ischemia) and gene-related retinal diseases with a focus on Stargardt’s disease.

Boehringer Ingelheim’s retinal health strategy includes the development of novel delivery platforms to address unmet need for people living with retinal conditions. Digital innovation for early detection and intervention, moving towards precision medicine regimens and remote treatment monitoring are additional key elements.

# # #

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than

53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com

About CDR-Life

CDR-Life is developing highly specific antibody therapeutics to target intracellular proteins presented on the major histocompatibility complex (MHC). Our versatile MHC-targeted antibody platform increases access to a vast array of antigens that were not previously addressable, to develop a pipeline of first in class therapeutics across a broad range of solid tumors. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to redirect and activate the patient’s own immune system to eliminate their tumors.

Media Contacts

Boehringer Ingelheim:
Dr. Reinhard Malin
Boehringer Ingelheim Corporate Center GmbH
Innovation Unit/Bio Comms, Corp. Affairs
Media + PR
press@boehringer-ingelheim.com

Linda Ruckel 
Boehringer Ingelheim Corporate Center GmbH
Innovation Unit/Bio Comms, Corp. Affairs
Media + PR
P: 203-791-6672 
press@boehringer-ingelheim.com

CDR-Life:
Holly Hancock
MacDougall Advisors
hhancock@macdougall.bio


[1] Tufail A, et al. Objective Measurement of Reading Speed and Correlation With Patient-Reported Functional Reading Independence. Presented at the 15th EURETINA Congress, Nice, France, September 17-20, 2015

CDR-Life Announces Second Milestone Achievement with Boehringer Ingelheim in Developing AntibodyFragment-based Therapeutics for Geographic Atrophy 

August 2, 2023

Zürich, Switzerland, August 2, 2023 – CDR-Life Inc. today announced a milestone payment triggered by the achievement of a development milestone with a partnered antibody fragment-based drug candidate that could significantly slow down the progression of geographic atrophy (GA). Boehringer Ingelheim and CDR-Life entered a collaboration and licensing agreement in May 2020 and announced the selection of an antibody fragment-based therapeutic candidate in September 2021.

GA is a progressive, irreversible retinal disease and one of the leading causes of blindness in people over 65 years of age. It occurs in people living with age-related macular degeneration (AMD) and affects approximately eight million people globally. 

“This milestone is continued validation of the expertise of our team to identify high quality antibody fragment-based drug candidates across a broad range of therapeutic applications,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “Our partnership with Boehringer Ingelheim has proven successful and will hopefully bring life changing new treatments for people living with this devastating disease.”

In addition to partnering with Boehringer Ingelheim, CDR-Life is building its own pipeline of novel antibody fragment-based T cell engagers against solid tumors. By uniquely targeting the major histocompatibility complex (MHC), CDR-Life is able to access a new class of intracellular tumor antigens to engage T cells. The company’s first of several therapeutic candidates in development, CDR404, targets MAGE-A4 and is anticipated to enter the clinic in 2024. 

About CDR-Life

CDR-Life is developing highly specific antibody therapeutics to target intracellular proteins presented on the major histocompatibility complex (MHC). Our versatile MHC-targeted antibody platform increases access to a vast array of antigens that were not previously addressable, to develop a pipeline of first in class therapeutics across a broad range of solid tumors. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to redirect and activate the patient’s own immune system to eliminate their tumors.  

Contacts
Media:
Holly Hancock
MacDougall Advisors
hhancock@macdougall.bio

CDR-Life Announces the Appointment of Nicole Onetto, MD, MSc, to Board of Directors

December 8, 2022

Zürich, Switzerland, December 8, 2022 – CDR-Life Inc., a biotechnology company pioneering a new and differentiated class of highly tumor-selective immuno-oncology therapeutics based on its proprietary antibody-based MHC-targeting T cell engager technology, today announced the appointment of Nicole Onetto, MD, MSc to the Company’s Board of Directors.

Dominik Escher, Executive Chairman of CDR-Life, said: “As CDR-Life is moving to clinical development with its novel MHC-targeting immunotherapies in cancer, the board decided to further strengthen its expertise in the field of oncology. We are very pleased to welcome Dr. Nicole Onetto to our Board. She brings an impressive track record and a wealth of experience in developing novel and innovative drugs in oncology.”

CDR-Life’s Chief Executive Officer, Christian Leisner, PhD, added, “We are excited to have Nicole join the board as we continue to advance our pipeline and mission to create new and highly tumor-targeted immunotherapies. Nicole’s scientific and medical background along with her deep expertise in oncology, drug development and commercialization will be particularly helpful as we work together to bring forward novel MHC-targeting biotherapeutics to patients with urgent unmet medical needs.”

Prior to joining CDR-Life’s Board of Directors, Dr. Onetto was a Deputy Director and Chief Scientific Officer at the Ontario Institute for Cancer Research in Toronto. Before that, she held executive positions in pharmaceutical and biotechnology companies in Canada, the USA, and Europe, including the positions of Chief Medical Officer at ZymoGenetics, and Chief Medical Officer at OSI Pharmaceuticals where she led the clinical development leading to the US and European approvals of Tarceva® (erlotinib) in collaboration with Genentech and Roche. Dr. Onetto previously worked in senior management positions at Bristol Myers Squibb (BMS), Nexstar Pharmaceuticals, and Gilead Sciences. At BMS, she was the international project leader for Taxol (paclitaxel) and contributed to several international market authorizations for Taxol in ovarian cancer and breast cancer.  At Gilead, she was the Senior Vice President responsible for clinical, drug safety and regulatory operations for the entire Gilead portfolio and was also head of the oncology drug development team which was subsequently acquired by OSI Pharmaceuticals.

“I am delighted to join the Board and look forward to working with CDR-Life’s experienced leadership team to deliver on the goal of developing highly specific MHC-targeting biotherapeutics that have the potential to meet urgent medical needs for many cancer patients” said Dr. Onetto M.D. “Despite the power of current cancer immunotherapies, their efficacy and safety are limited by off-tumor activity. By accessing a pool of highly attractive cancer antigens only found within tumor cells, CDR-Life’s approach has the potential to solve the problem of non-tumor selectivity with a new class of antibody fragment-based T cell engagers.”

Dr. Onetto currently serves as a director on the boards of Basilea Pharmaceutica, Viracta Therapeutics (following a reverse merger with Sunesis Pharamceuticals) and Bolt Biotherapeutics. Previously she served on the boards of Sierra Oncology, ImmunoGen, YM Biosciences and NBE Therapeutics, until the acquisition by Boehringer Ingelheim. She was also director for several private companies during her tenure       at the Ontario Institute for Cancer Research. Dr. Onetto holds a medical degree from the University of Paris and a Master of Pharmacology from the University of Montréal.  She is Board certified from the University of Paris in pediatrics and hematology. 

CDR-Life to Participate in the 2022 Jefferies London Healthcare Conference

November 1, 2022

Zürich, Switzerland, November 1, 2022 –CDR-Life Inc., a biotechnology company pioneering a new and differentiated class of highly tumor-selective immuno-oncology therapeutics based on its proprietary antibody-based MHC-targeting T cell engager technology, today announced that Christian Leisner, Chief Executive Officer and Björn Peters, Chief Business Officer, will participate in one-on-one meetings at the upcoming Jefferies London Healthcare Conference from November 15-17, 2022 in London, United Kingdom. 

CDR-Life Announces Appointment of Swethajit Biswas, MD, as Chief Medical Officer

August 23, 2022

Former Medicine Development Leader for MAGE-A4+ Autologous Cell Therapies Will Support Advancement of CDR-Life’s M-gager® Solid Tumor Therapies

Zürich, Switzerland, August 23, 2022 – CDR-Life Inc., a biotechnology company pioneering a new and differentiated class of highly tumor-selective immuno-oncology therapeutics based on its proprietary antibody-based MHC-targeting T cell engager technology, today announced the appointment of Swethajit Biswas, MD, FRCP to the position of Chief Medical Officer, effective immediately. 

Prior to joining CDR-Life, Dr. Biswas was a Development Leader for MAGE-A4+ autologous cell therapies at Adaptimmune Therapeutics plc, progressing afamitresgene autoleucel through an accelerated approval submission pathway. Before that, he was a Clinical Director in oncology drug development at GlaxoSmithKline (GSK) Oncology, UK, serving as the clinical lead for the company’s BCMA-targeting multiple myeloma program with multiple trials across all phases of development. Dr. Biswas previously worked as a National Health Service (NHS) Consultant with clinical expertise in teenage cancer medicine, sarcoma, lymphomas and brain tumors at two university teaching hospitals in the UK. He also held an academic position as a Clinical Senior Lecturer in medical oncology at Newcastle University’s Northern Institute for Cancer Research (NICR) from 2009 to 2013. Dr. Biswas received his medical degree from Sheffield University Medical School and his DPhil from the University of Oxford. Dr. Biswas became an elected Fellow of the Royal College of Physicians (FRCP), London, in 2020. 

“We are excited to welcome Dr. Biswas and are confident that his deep scientific understanding of medical need, tumor biology, and MHC-targeting immunotherapy development make him a powerful addition to CDR-Life,” said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. “Dr. Biswas joins us with twelve years of senior experience in oncology drug development that includes overseeing several trials developing BCMA therapies in multiple myeloma as well as leading a MAGE-A4 targeting TCR T cell therapy in solid tumors through accelerated approval designation. This experience will strengthen our team and Dr. Biswas will be a welcome addition as we continue to advance our pipeline and mission to create new and highly tumor-targeted immunotherapies.”

“I am very pleased to join CDR-Life at this exciting time and look forward to helping advance both the Company’s lead program, CDR404, a first of its kind dual MAGE-A4 T cell engager which targets solid tumors across multiple indications, as well as its robust pipeline,” said Dr. Biswas, Chief Medical Officer of CDR-Life. “There remains a huge need for new treatment modalities for cancer patients and CDR-Life’s unique antibody technology has the very exciting potential to target a broad universe of intracellular antigens, including cancer testis antigens and oncogenic driver proteins, with unparalleled specificity and affinity, using off-the-shelf medicines which are convenient for patients.”

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CDR-Life Announces $76 Million Raised in Series A Funding

April 13, 2022

Proceeds Support Advancement of the M-gager® Platform Technology and Lead Product Candidate CDR404, a First Antibody Fragment-based Dual MAGE-A4 T Cell Engager, and Other Discovery Programs

Zürich, Switzerland, April 13, 2022 – CDR-Life Inc., a biotechnology company pioneering a new and differentiated class of highly tumor-specific immuno-oncology therapeutics based on its proprietary antibody-based MHC-targeting T cell engager technology, today announced the closing of a $76 million Series A financing led by Jeito Capital and RA Capital Management, with participation from Omega Funds. In connection with the financing, Rafaèle Tordjman, Founder & CEO of Jeito Capital, Daniel Marks, Principal of RA Capital, and Claudio Nessi, Managing Director of Omega Funds, will join the Company’s Board of Directors.

CDR-Life is currently advancing its lead program, CDR404, a first of its kind dual MAGE-A4 T cell engager which targets solid tumors across multiple indications, based on the Company’s unique M-gager® technology. Proceeds from the Series A financing will advance CDR404 through potential clinical proof-of-concept readout as well as expansion of the pipeline leveraging the Company’s M-gager® technology for targeting intracellular antigens positioned to deliver unparalleled specificity and affinity in solid tumors. 

“We are honored to have the support of these high-caliber investors, reflecting both the critical need for effective T cell engaging therapies against solid tumors and the support of the CDR-Life product engine and development pipeline,” said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. “The proceeds from this financing allow us to fund our first clinical proof-of-concept opportunity with CDR404, while continuing development of novel targeted immunotherapies based on CDR-Life’s superior T cell engaging platform. We are thankful to have the opportunity of raising a significant Series A round in such challenging times with an excellent European and US co-led investor group, assisting us in advancing our pipeline and goal of empowering cancer patients with uniquely targeted immunotherapies.”

“We are thrilled to invest in CDR-Life which absolutely embodies our investment strategy with its high-quality science in T cell engagers, expert leadership team which has together already built a previous successful Biotech company, strong syndicate of investors and significant capital. Jeito Capital with this 10th investment is building a diversified portfolio of the next generation of European biotech leaders with a global reach in different therapeutic areas and development stages. CDR-Life is ideally positioned to accelerate its therapies based on innovative modalities for the benefit of millions of patients with limited therapeutic options. We look forward to support CDR-Life’s success,” said Rafaèle Tordjman, Founder and CEO of Jeito Capital.

“CDR-Life has the deep biologics and platform technology expertise to rapidly develop bispecific molecules against this promising, but challenging, class of intracellular targets,” said Daniel Marks, Principal of RA Capital. “We’re especially pleased to be working with these leading healthcare investors and this experienced and talented leadership team.”

Based in Switzerland, CDR-Life is led by an experienced team of biotech executives who have developed new medicines and closed substantial biotech deals, including Beovu® and ESBATech. The Company has an ongoing partnership with Boehringer Ingelheim, advancing its program, CDR202, into preclinical stage of development targeting macular degeneration. Clinical candidate, CDR101, a next generation BCMA, CD3, and PD-L1 targeting trispecific antibody in preclinical development for the treatment of multiple myeloma (MM) has recently demonstrated increased in vitro activity compared to clinical stage-like bispecific BCMA therapies, inducing superior T cell activation in bone marrow samples of MM patients and more durable tumor eradication in a mouse xenograft model. CDR101 is ready for IND-enabling studies.

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CDR-Life to Present at the American Association for Cancer Research 2022 Annual Meeting

March 22, 2022

Zürich, Switzerland, March 22, 2022 – CDR-Life Inc., a biotechnology company pioneering a new and differentiated class of highly tumor-specific immuno-oncology therapeutics based on its proprietary antibody-based T cell engager technology (M-gager®), today announced that preclinical data for the Company’s lead development candidate, CDR404, a first of its kind dual MAGE-A4 T-cell engager,  has been selected for a poster presentation at the upcoming 2022 American Association for Cancer Research Annual Meeting, being held April 8-13 in New Orleans, LA. 

Details for the poster presentation are as follows:

Abstract Number: 2891

Poster Title: Enhanced Anti-tumor Responses with a Novel Dual pMHC T-cell Engager Bispecific Antibody 

Session Number & Name: Therapeutic Antibodies 2

Session Date: Tuesday, April 12, 2022

Session Time: 9:00 AM – 12:30 PM

Presenter: Stephanie Jungmichel, Pharmacology Leader, CDR-Life

CDR-Life Announces Positive Preclinical Data on CDR101 Program Presented at the American Society of Hematology’s 2021 Annual Meeting

December 13, 2021

Zürich, Switzerland, December 13, 2021 CDR-Life Inc., a biotechnology company pioneering a new and differentiated class of highly tumor-specific immuno-oncology therapeutics based on its proprietary antibody-based T cell engager technology, today announced that one of the Company’s pharmacology experts, Dr. Melissa Vrohlings, presented preclinical data on CDR101, a next generation BCMA, CD3, and PD-L1 targeting trispecific antibody, in development for the treatment of multiple myeloma. The data were presented in a poster presentation at the 63rd Annual American Society of Hematology (ASH) meeting in Atlanta, Georgia.

“CDR101, a next generation T cell engager, demonstrated that targeting BCMA with simultaneous blockade of PD-L1 leads to improved myeloma cell killing and more durable responses in vivo compared to clinically validated therapies,” said Christian Leisner, PhD, Chief Executive Officer at CDR-Life. “In contrast to high-affinity PD-L1 immune checkpoint inhibitors, CDR101 selectively inhibits PD-L1 at the immune synapse preventing on-target off-tumor effects.  We expect this to translate into longer efficacy in relapsed or refractory MM patients without the immune-related adverse events seen with checkpoint inhibitor combination therapies.”

Key findings:

  • CDR101 demonstrated increased in vitro activity compared to clinical stage-like bispecific BCMA therapies
  • CDR101 induced superior T cell activation in bone marrow samples of MM patients and increased primary myeloma cell death by T cells
  • The concept of simultaneously blocking BCMA and PD-L1 has shown complete and more durable tumor eradication in a mouse xenograft model

The results clearly support the further development of CDR101. The company plans to initiate IND-enabling activities together with a partner.

CDR-Life to Present at the American Society of Hematology’s 2021 Annual Meeting

November 8, 2021

Zürich, Switzerland, November 8, 2021CDR-Life Inc., a biotechnology company pioneering a new and differentiated class of highly tumor-specific immuno-oncology therapeutics based on its proprietary antibody-based T cell engager technology, today announced that preclinical data from the Company’s CDR101 candidate will be  presented  in a poster at the 63rd Annual American Society of Hematology (ASH) meeting being held in Atlanta, Georgia from December 11 -14, 2021.

Details for the poster presentation are as follows:

Abstract Number: 1583

Poster Title: Preclinical Assessment of CDR101 – a BCMAxCD3xPD-L1 Trispecific Antibody with Superior Anti-Tumor Efficacy

Session Number & Name: 651.Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster I Hematology Disease Topics & Pathways: Biological, Translational Research, Bispecific Antibody Therapy, Plasma Cell Disorders, Checkpoint Inhibitor, Diseases, Therapies, Lymphoid Malignancies

Session Date: Saturday, December 11, 2021

Session Time: 5:30 PM – 7:30 PM

Presenter: Melissa Vrohlings, Immunology Expert, CDR-Life

CDR-Life Announces Expansion of Scientific Advisory Board

October 26, 2021

Two renowned experts join to advise CDR-Life as the company advances pipeline of novel cancer therapeutic candidates

Zürich, Switzerland, October 26, 2021 – CDR-Life Inc., a biotechnology company pioneering a new and differentiated class of highly tumor-specific immuno-oncology therapeutics based on its proprietary antibody-based T cell engager technology, today announced that top world leading experts in the field of novel immunotherapy drug development and antibody-based T cell engagers joined the company’s Scientific Advisory Board (SAB).

“We are pleased to welcome Dr. Hong and Dr. Reiter, both world-renowned leaders in the fields of developing innovative immunotherapies and T cell receptor-like antibodies,” said Christian Leisner, PhD, Chief Executive Officer at CDR-Life. “Their guidance will be integral to building our future as a leader in the development of game-changing therapies that have the potential to alter the treatment paradigm for cancer patients”.

The additions to the SAB include:            

David S. Hong, MD      

Dr. David Hong is a Professor and Deputy Chair of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, where he has helped form one of the largest Phase I clinical trial units worldwide.

Dr. Hong is an expert in the early clinical development of innovative immunotherapies and targeted therapies and has served as the principal investigator for more than 100 trials. He has been involved in the early development of various drugs – including larotrectinib, sotorasib and levatinib – leading up to their eventual FDA approvals. As an expert in c Met NTRK, and KRAS, he has led several national trials, including the c-Met amplified, c-Met exon 14 deleted and NTRK arms of the NCI-MATCH trial.

Yoram Reiter, PhD
Dr. Yoram Reiter is a Professor of Immunology and the head of the Laboratory of Molecular Immunology and Cancer Immunotherapy at the Technion-Israel Institute of Technology. His research involves basic and translational research in antibody and cell engineering for the design of novel immunotherapies.

Dr. Reiter is a pioneer in the field of T cell receptor (TCR)-mimicking antibodies. His work led to the creation of Applied Immune Technologies developing next generation antibody-based immunotherapies. AIT was acquired and merged into Adicet Bio Inc (NASDAQ:ACET). He has more than 25 years of experience in molecular immunology, antibody and cell engineering related to cancer immunotherapy. His lab combines basic and translational research related to T cell biology, effector T cells functions, design of optimal CARs as well as multiple projects on antibody engineering and T cell engagers. Dr. Reiter was the dean of the faculty of Biology (twice) and is director of an institutional interdisciplinary research. He published over 120 papers, patents, review articles in the fields of molecular immunology and antibody engineering.

The new advisors will join existing SAB members Professor Ulrich Jäger, MD, Professor Markus Manz, MD, and Assistant Professor Joshua Richter, MD.      

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CDR-Life Announces the Advancement of Antibody Treatment for Patients with Geographic Atrophy with Development Partner Boehringer Ingelheim

September 8, 2021

Important milestone reached in the development of antibody fragment-based therapeutics for geographic atrophy under collaboration and licensing agreement with Boehringer Ingelheim

Zürich, Switzerland, September 8, 2021 – CDR-Life Inc., today announced that Boehringer Ingelheim has selected an antibody fragment-based therapeutic candidate for advancement to the next phase of development under the existing agreement between the companies for the discovery and development of novel therapies for the treatment of geographic atrophy (GA), triggering an undisclosed milestone payment from Boehringer Ingelheim to CDR-Life. GA is a blinding retinal disease that occurs in patients with age-related macular degeneration (AMD) and for which there is no treatment.

“We have had an incredibly productive and seamless research collaboration between Boehringer Ingelheim and CDR-Life, and together taken an important step towards identifying a candidate with the potential to address the unmet medical need posed by this devastating disease,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life.

About Boehringer Ingelheim’s and CDR-Life’s Collaboration

Boehringer Ingelheim and CDR-Life entered into a collaboration and licensing agreement to research and develop antibody fragment-based therapeutics for geographic atrophy in May 2020.

Under the terms of the agreement, Boehringer Ingelheim will receive an exclusive, worldwide license to develop certain compounds based onCDR-Life ́stechnology against a specific target and will be responsible for global development and commercialization. CDR-Life will be eligible to receive up to CHF 474.5 million (USD 520 million) in upfront and success-based milestone payments, as well as research funding and royalties on sales.

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CDR-Life Appoints Industry Veteran Björn Peters as Chief Business Officer

June 10, 2021

Newly Created Role Positions CDR-Life to Pursue Additional Partnership Opportunities

ZÜRICH, Switzerland, June 9, 2021 – CDR-Life Inc., a biotherapeutics company developing tumor-specific immunotherapies based on a proprietary antibody platform, today announced the expansion of its leadership team with the appointment of Björn Peters as Chief Business Officer. In this newly created role, Mr. Peters, a highly seasoned biotechnology and pharmaceutical executive, will be primarily responsible for business development and will report directly to Chief Executive Officer, Christian Leisner, Ph.D.

“Björn’s addition to our management team marks an important milestone for CDR-Life as we continue to pursue strategic partnerships for our highly innovative antibody therapies,” stated Dr. Leisner. “Having spent more than two decades focused on business development, strategy and management within the biotechnology and pharmaceutical arenas, Björn’s proven experience and established relationships will be invaluable as we increase our visibility and look to expand opportunities for our tumor-specific T cell engagers.”

Mr. Peters added, “The targeting of intracellular antigens in tumor cells is a very promising approach to achieve better efficacy and safety outcomes and I am honored to join such a team of highly experienced and accomplished antibody specialists. I look forward to collaborating with my colleagues to further develop CDR-Life’s business strategy and to forge critical new partnerships which will help to progress the company’s growing portfolio of novel and promising immunotherapies across a range of indications.”

Prior to joining CDR-Life, Mr. Peters served as head of business development at both Allecra Therapeutics and Zealand Pharma. Earlier in his career, he held positions of increasing responsibility within business development at Shire Pharmaceuticals, Movetis (a spin-off from Johnson & Johnson, subsequently acquired by Shire Pharmaceuticals) and Johnson & Johnson subsidiary, Janssen-Cilag. During his tenure in business development, Mr. Peters has contributed to a successful series of both buy- and sell-side transactions with a total value exceeding $7 billon, including the sale of Movetis to Shire after the company went public on Euronext.

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CDR-Life Expands Board of Directors with Appointment of Dieter Gericke

May 18, 2021

With the appointment of Dieter Gericke, a seasoned attorney and long-time corporate advisor to the life sciences industry will join CDR-Life’s board of directors.

ZURICH, Switzerland, May 18, 2021 – CDR-Life Inc., a biotherapeutics company developing tumor-specific immunotherapies based on a proprietary antibody platform, today announced the appointment of Dieter Gericke, a seasoned attorney and long-time corporate advisor to the life sciences industry, to its board of directors, effective May 17, 2021.

“With a reputation as a trusted counselor to both large and small pharmaceutical and biotechnology companies throughout Europe and globally, Dieter’s decades of relevant experience, including deep transactional expertise, make him a perfect addition to our board,” stated Dominik Escher, Executive Chairman of CDR-Life. “We look forward to leveraging his vast network and knowledge base within the areas of private equity investments, capital markets, mergers and acquisitions (M&A), and corporate governance, as we continue to execute on our strategic plan, including future potential financings and exit options.”  

Mr. Gericke added, “CDR-Life has distinguished itself as a leading biotechnology company, using a novel and proprietary antibody fragment platform technology to develop a pipeline of oncology specific T cell engagers. I am honored to work with the executive team, who have an impressive track record of building companies as well as developing and commercializing new drugs.”

Mr. Gericke is a partner at Homburger AG, where, since 2014, he has served as head of the corporate/M&A practice team, and, since 2010, as head of the China focus group, counseling clients on public and private M&A, shareholder activism, equity capital markets including initial public offerings, private equity, and corporate governance matters, among others. During his tenure at the firm, which he joined in 2000, Mr. Gericke was also co-head of the capital markets team.

Among Mr. Gericke’s most recent assignments are the takeover of Syngenta by ChemChina; the sale of Therachon to Pfizer; the sale of PPF’s shares in NBE-Therapeutics to Boehringer Ingelheim, the IPOs of ADC Therapeutics and Zur Rose Group; and share issuances by Basilea Pharmaceutica, Molecular Partners, Santhera Pharmaceuticals and AC Immune.

During his career, Mr. Gericke has authored various publications and chaired a number of panels, including relating to public and private M&A, securities laws, and corporate governance. He is a member of the Corporate and M&A Committee and member and former vice-chair of the Securities Law Committee of the International Bar Association. Mr. Gericke is also a board member of Gericke Group, a producer of powder-processing equipment and systems for the food, pharmaceutical and chemical industries; and is a former board member of Syngenta AG, a leading agrotechnology group.

Mr. Gericke holds a law degree and doctorate from the University of Zurich and earned an LL.M. from Harvard Law School.

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CDR-Life Presents Results at AACR

April 16, 2021

A powerful discovery platform for the generation of high affinity and specificity TCR-like antibodies for immunotherapies in solid tumor

Abstract: Classical antibody and chimeric antigen receptor (CAR) T-cell therapies to treat cancer are limited to target cell surface proteins, which only constitute about 20-25% of all available tumor antigens. In addition, these surface antigens are typically not restricted to tumor cells. Targeting peptides presented in major histocompatibility complexes (pMHCs) offers great potential to exploit the intracellular reservoir of proteins associated with cancer. Soluble T cell receptor (TCR) proteins have been used to target pMHC-restricted tumor-specific antigens. However, their low affinity and substantial challenges related to stability and production compromise their developability as drugs. We developed a discovery platform for the selection of TCR-like antibodies with high target specificity and affinity. This provides access to the intracellular antigen repertoire analogous to TCRs but with much higher affinity as well as the clinical validation and format versatility of monoclonal antibodies (mAbs). As proof of concept, we used the HLA-A*02:01 (HLA-A2) restricted MAGE-A4 epitope GVYDGREHTV. A broad collection of antibodies was isolated from scFv phage libraries specifically designed to bind pMHC-complexes. Based on initial compound screening with ELISA and sequence analysis, a set of binders was selected for further SPR affinity characterization. Out of 1482 hits, several binders showed KD values in the picomolar range for the MAGE-A4/HLA-A2 complex and no binding against HLA-A2 in complex with unrelated peptides. Additionally, specific binding in a cellular context was verified for selected leads by flow cytometry using T2 cells pulsed with MAGE-A4 peptide while no binding was observed to T2 cells pulsed with control peptides with high similarity to MAGE-A4. The best performers were selected to generate CD3-based bispecific T cell engagers (TCE), for which potent killing was demonstrated in several MAGE-A4/HLA-A2 positive cancer cell lines of different histological origin, including lung cancer, melanoma, bladder cancer and osteosarcoma, as well as in a xenograft mouse model. No off-target activity was observed in MAGE-A4 negative, HLA-A2 positive control cells. Notably, cytotoxicity was significantly potentiated by concomitant blockade of the PD-1/PD-L1 axis supporting the concept of sensitizing solid tumors with TCEs to immune checkpoint inhibitor (ICI) therapy. In summary, we demonstrated the potential of our platform to deliver TCR-like antibodies with high affinity and specificity against intracellular antigens proven by efficient and specific killing of MAGE-A4/HLA-A2 positive cancer cells with bispecific TCEs. For the first time, we showed the synergistic effect of combining pMHC-specific TCEs with ICI treatment corroborating the potential of this treatment modality to overcome major limitations of current cancer immunotherapies.

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Boehringer Ingelheim Collaborates with CDR-Life to Develop Antibody Fragment-based Therapeutics For Geographic Atrophy, a Leading Cause of Blindness Worldwide

May 13, 2020

The collaboration with CDR-Life is the second strategic partnership within a year for Boehringer Ingelheim in retinal diseases, furthering the company’s commitment to develop novel treatments and technologies for patients who have only inadequate treatment options

Together the partners will advance CDR-Life’s preclinical antibody fragments targeting a key pathway in geographic atrophy (GA)

Ingelheim, Germany and Schlieren, Switzerland – 13 May 2020 – Boehringer Ingelheim and CDR-Life today announced they have entered into a collaboration and licensing agreement to research and develop antibody fragment-based therapeutics for geographic atrophy (GA). GA is a progressive, irreversible retinal disease that occurs in patients with age-related macular degeneration (AMD) for which there is no current treatment. Together, with Boehringer Ingelheim’s expertise in the therapeutic development of biologics and CDR-Life’s strong know-how in antibody engineering, the two companies will progress CDR-Life’s preclinical candidate, with the aim to preserve sight for patients with GA.

“Partnering with CDR-Life provides Boehringer Ingelheim with the opportunity to collaborate with a team that has a proven track record developing antibody fragment-based therapeutics for retinal diseases,” said Clive R. Wood, Ph.D., Corporate Senior Vice President and Global Head of Discovery Research at Boehringer Ingelheim. “The prospect of losing one’s sight is frightening. We are committed to transformational therapies that have the potential to succeed in preserving the health and vision of patients with retinal diseases such as geographic atrophy”

Utilizing antibody fragment-based technology, which retains the specificity of an antibody while significantly reducing the size of the molecule, may have significant advantages over traditional large molecule approaches for the treatment of retinal diseases, such as GA. When applied to the eye via intravitreal injection, high affinity antibody fragment therapies have the potential to reach the retinal pigment epithelial cells where degeneration is known to occur. This precise technology may help decrease the cellular stresses caused by AMD and prevent further loss of sight.

“Boehringer Ingelheim is one of the leading research and development companies in the field of biologics,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “This is an exciting partnership that brings together Boehringer Ingelheim’s development expertise and CDR-Life’s innovative antibody fragments to provide hope for people living with a blinding retinal disease. We look forward to advancing this project towards the clinic together with the Boehringer Ingelheim team.”

Boehringer Ingelheim takes a holistic approach to the development of novel retinal disease therapies, targeting key mechanisms in the pathogenesis of retinal diseases. By leveraging existing expertise in oncology, inflammation, neurodegeneration, fibrosis and cardiometabolic diseases, the company has built a comprehensive portfolio of next generation retinal therapy approaches in various stages of development up to Phase 2 in macular degeneration and diabetic retinal diseases.

CDR-Life´s preclinical program utilizing antibody fragment-based technology complements this growing portfolio, providing an innovative approach to treat GA.

Under the terms of the agreement, Boehringer Ingelheim will receive an exclusive, worldwide license to develop certain compounds based on CDR-Life´s technology against a specific target and will be responsible for global development and commercialization. CDR-Life will be eligible to receive up to CHF 474.5 million in upfront and success-based milestone payments, as well as research funding and royalties on sales.

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CDR-Life moves into larger facilities in the Bio-Technopark, Schlieren

January 30, 2020

ZURICH, Switzerland, January 30, 2020 – CDR-Life inc. has moved into new fully equipped laboratory facilities in Wagistrasse 27, 8952 Schlieren-Zurich. This move positions the company to grow and to advance its promising pipeline of game-changing oncology and ophthalmology therapies into clinical trials over the coming years.

CDR-Life Enters Research Collaboration with University Hospital Zurich

October 28, 2019

Ex vivo studies for the prediction of clinical response in multiple myeloma.

ZURICH, Switzerland, October 28, 2019 – CDR-Life inc. has entered a research collaboration with Prof. Markus G. Manz, MD, Head of Medical Oncology and Hematology at University Hospital and University of Zurich, to further test CDR-Life’s trispecific antibodies on primary cancer patient tissue.

The collaboration will combine strong clinical know-how and patient sample access at the University Hospital with CDR-Life’s deep expertise in developing unconventional antibody- based therapies.

“CDR-Life’s trispecific LocATE antibodies are potentially transformative in the field of immunotherapies,” said Prof. Manz. “We are looking forward to help validate the promise of this novel approach.”

“Patient ex vivo testing has been shown to be highly predictive of clinical outcome” said Leonardo Borras, Chief Science Officer at CDR-Life. “Access to world-class expertise and real patient samples for testing our novel antibodies is very powerful.”

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CDR-Life Presents Results at ASCO

June 3, 2019

Local activator and T cell engager (LocATE) selectively blocks PD-L1 at the cytolytic synapse for deeper responses in multiple myeloma.

Poster Abstract

CDR-Life Enters Research Collaboration with ETH Zürich

May 23, 2018

Ex vivo drug response profiling of novel immunotherapies in patient biopsies.

ZURICH, Switzerland, May 23, 2018 – CDR-Life inc. has entered a research collaboration with Prof. Berend Snijder, ETH Zürich, to study the effect of their novel trispecific T cell engagers on cancer patient samples using pharmacoscopy, a human ex vivodrug screening technology.

The collaboration will use synergies between the modular multispecific immunotherapies from CDR-Life and the pharmacoscopy technology from the Snijder laboratory to explore both the biology that drives immune cell engagement and the principles that guide optimal drug design.

“CDR-Life’s multispecific molecules are ideal together with our pharmacoscopy technology to deduce impactful learnings about the biology of immune cell engagement” said Prof. Snijder.

“Pharmacoscopy has been shown to be highly predictive of clinical outcome,” said Dr. Christian Leisner, chief executive officer of CDR-Life. “This is contrary to many in vitro and in vivo methods and makes it a powerful tool to understand the impact of our trispecific immunotherapies.”

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CDR-Life Announces Formation of Scientific Advisory Board

Inaugural Members Include Leading Ophthalmic Luminaries from the United States and Europe.

ZURICH, Switzerland, May 8, 2017 – CDR-Life Inc., a biotechnology company focused on advancing therapeutic antibody fragments in the areas of ophthalmology and oncology, today announced the formation of a Scientific Advisory Board (SAB) comprised of academic and industry experts in the field of ophthalmology from both the United States and Europe.

The Scientific Advisory Board will serve as a vital strategic resource to the Company to develop novel treatments for ophthalmic diseases. In addition to guiding CDR-Life’s research and development activities, including clinical trial designs, the SAB will also identify new target indications and will evaluate strategic assets that leverage the management’s expertise in therapeutic antibody fragments.

“We are pleased to welcome this diverse group of ophthalmic experts, representing thought leaders from clinical practice and academia, to our newly formed Scientific Advisory Board,” said Dominik Escher, PhD, executive chairman of CDR-Life. “The expertise that they bring to our executive team and Board will prove invaluable as we refine our clinical plan and work to bring novel therapies to patients in need.”

“We believe our approach to developing novel therapeutic antibody fragments holds significant potential in ophthalmology and oncology where unmet medical needs persist,” said Christian Leisner, PhD, chief executive officer of CDR-Life. “We look forward to leveraging the varied experience of our new Scientific Advisory Board as we pursue the efficient development of our proprietary molecules.”

The Advisory Board members include:

Reza Dana, MDDirector at Harvard Medical School, Department of Ophthalmology, Cornea Center of Excellence

Pravin Dugel, MDManaging Partner, Retinal Consultants of Arizona (RCA)

Frank G. Holz, MDChairman and Professor at the Department of Ophthalmology, University of Bonn

Stephan Michels, MDProfessor at the University of Zurich and Vice Chair at City Hospital Triemli, Zurich, Switzerland

Manfred Zierhut, MDProfessor at University Hospital of Tuebingen, Germany

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