Our Science

Antibody-based T cell engagers

“CDR-Life’s T cell engaging antibodies are potentially transformative in the field of cancer immunotherapies”

Prof. Markus G. Manz, MD, Head of Medical Oncology and Hematology at University Hospital and University of Zurich, Switzerland

Our M-gager® Platform

IMMUNOTHERAPIES

CDR-Life is at the forefront of developing next-generation therapeutics that overcome the limitations of traditional immunotherapies. For cancer, we’re creating T cell engagers against challenging targets with enhanced tumor selectivity and our lead program CDR404 is in Phase 1. For autoimmune diseases, our therapies target specific immune cell populations with the goal to reset the immune system to a healthy state.

Our goal is to enhance therapeutic efficacy while reducing side effects, potentially expanding the reach of these innovative therapies to benefit a wider range of patients – whether they’re fighting cancer or managing devastating autoimmune conditions. By
targeting disease-specific pathways with
unprecedented precision, we’re working to
transform treatment outcomes across
multiple therapeutic areas.

Our M-gager® Platform

Targeted T Cell Engagers

Based on more than 20 years of experience in cutting-edge antibody fragment design, engineering and production, CDR-Life’s integrated end-to-end antibody-based platform drives innovation in both oncology and autoimmune disease. Our platform rapidly delivers optimized therapeutic candidates against challenging targets with attractive drug properties and streamlined manufacturing processes, dramatically accelerating the path from discovery to development. In oncology, we develop novel tumor-targeted T cell engagers (TCEs), addressing challenging targets on hard-to-treat solid tumors that offer enhanced cancer selectivity. For autoimmune conditions, we harness this same precision technology to target specific immune cell populations with the goal of restoring the immune system to a healthy state.

We are advancing a pipeline of potent tumor-selective TCEs and targeted autoimmune therapeutics, aiming to increase therapeutic efficacy while minimizing side effects across both disease areas. Our candidates are designed with manufacturability in mind, featuring robust stability profiles and established production processes that enable efficient scale-up from research to clinical manufacturing.

CDR-Life’s unique M-gager® platform has the capability to target a broad spectrum of disease-specific antigens. In oncology, this includes challenging surface antigens as well as intracellular antigens displayed on the major histocompatibility complex (MHC). For autoimmune conditions, we precisely target disease-driving immune cell populations. Our modular format with unparalleled antigen binding specificity enables selective targeting of diseased cells while sparing healthy tissues. By combining precise targeting with a modular and flexible format, CDR-Life is developing truly selective therapeutics that can leverage immune responses based on disease context. Our unique M-gager® platform can deliver attractive clinical candidates in a matter of months, which provides an excellent basis for R&D collaborations on novel targets.

M-gager® demonstrates excellent drug properties

CDR-Life’s M-gager® platform is our proprietary technology designed to develop highly targeted, antibody-derived T cell engagers. Utilizing a unique phage display library with billions of small antibody fragments, we deliver a modular technology that achieves unparalleled antigen specificity in the T cell engager format, leading to effective and selective T cell recruitment. M-gager® molecules have excellent drug properties and are anticipated to be highly effective immunotherapies for a wide range of promising targets.

How do M-gager® molecules work?

The unique tumor antigen-specific moieties recognize and attach to cancer cells, while the anti-CD3 effector function engages CD3 on T cells. Concurrently, they signal a patient’s T cells to create a powerful cancer-fighting zone. The simultaneous binding of both the tumor antigen and CD3 promotes the formation of a cytolytic synapse between T cells and tumor cells, enabling T cells to release special proteins that can break down cancer cells without harming healthy ones.
As this process happens, the patient’s body creates more T cells specifically trained to recognize these cancer cells. Some of these new T cells become ‘memory cells,’ providing ongoing protection against cancer’s return. This immunological memory forms the basis for durable responses observed in some patients following successful immunotherapy. The activated T cells send out signals to attract even more immune cells to the tumor site. This triggers a coordinated, multi-pronged attack on cancer cells that can lead to more effective and longer-lasting treatment outcomes.

Collectively, M-gager® molecules trigger a cascade of T cell biological effects including (1) T cell activation, (2) polyclonal expansion, (3) memory formation, and (4) peripheral recruitment, which together facilitate the synergistic lysis of tumor cells.

Our Pipeline

Our diversified and growing pipeline of highly targeted T cell engagers addresses solid tumors and autoimmune diseases – two areas of significant unmet medical need.

Based on more than 20 years of experience in cutting-edge antibody fragment design, engineering and production, CDR-Life’s integrated end-to-end antibody-based platform drives innovation in both oncology and autoimmune disease. In oncology, we develop novel tumor-targeted T cell engagers (TCEs), addressing challenging targets on hard-to-treat solid tumors that offer enhanced cancer selectivity. For autoimmune conditions, we target specific immune cell populations with the goal to reset the immune system to a healthy state.

With this pipeline, we aim to increase therapeutic efficacy while minimizing side effects across both disease areas. Our lead program, CDR404 is in clinical testing.

CDR-Life’s unique M-gager® platform has the capability to target a broad spectrum of disease-specific antigens. In oncology, this includes challenging surface antigens and intracellular antigens displayed on the major histocompatibility complex (MHC). For autoimmune conditions, we precisely target disease-driving immune cell populations. Our modular format with unparalleled antigen binding specificity enables selective targeting of diseased cells while sparing healthy tissues. By combining precise targeting with a modular and flexible format, CDR-Life is developing truly selective therapeutics that can either activate or regulate immune responses based on disease context.

CDR202/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 geographic atrophy (GA) disease pathology.
CDR505 is a tumor-selective M-gager® targeting novel cancer testis antigen, KK-LC-1, on HLA-A*01. This target is highly prevalent in common cancers and relevant for a yet unaddressed HLA-A*01 patient population.
CDR813 is a differentiated M-gager® targeting PRAME with unparalleled potency and specificity. PRAME is a pan-cancer target expressed exclusively in cancer, and not normal tissue.
CDR404, our most advanced program, is a potent and tumor-selective M-gager® targeting the cancer testis antigen, MAGE-A4, an intracellular cancer specific antigen with expression in several frequent and difficult-to-treat solid tumors including lung, bladder and head and neck cancer.
CDR111 is a T cell engager targeting two complementary B cell targets for highly effective B cell depletion with cure potential in multiple autoimmune diseases.
TE C HNO L O G Y P RO G RA M INDIC A TION S DISC O VE R Y IND-ENABLING CLINICAL CDR404 MAGE-A4 CDR813 PRAME Solid tumor CDR505 KK-LC-1 Ovarian, lung, head and neck cancer Solid tumor Solid tumor M-gager® pMHC targeted TCE CDR609 SOLID TUMOR Undisclosed M-gager® Cell surface targeted TCE Phase 1/2 CDR111 Trispecific TCE CDR202 Undisclosed Macular Degeneration M-gager® Fragment OTHER INDICATIONS M-gager® Cell surface targeted TCE Autoimmunity partnered start of Phase 2 Phase 1/2 start of Phase 2

CDR404

Urgent need for new therapies in solid tumors
MAGE-A4 is commonly overexpressed in difficult-to-treat solid tumors including non-small cell lung, head and neck, synovial sarcoma, bladder, and gynecological malignancies. Redirecting T cell migration towards MAGE-A4 positive tumors is likely to be an important treatment option for these patients.

What is MAGE-A4?
Melanoma-associated antigen A4 (MAGE-A4) is a protein that has minimal or no presence in healthy tissue but exhibits increased expression in several solid tumors. Tumor cells display MAGE-A4 fragments on their cell membrane via the Human Leukocyte Antigen (HLA) protein.

CDR404 – a novel molecule for cancer treatment
Currently, cancer-specific proteins such as MAGE-A4 can only be targeted by highly complex treatments, like engineered cell therapies, which are individualized and expensive to manufacture and produce. CDR404 is a potent off-the-shelf treatment and is a first-of-its-kind, antibody-based MAGE-A4 T cell engager for MAGE-A4 positive solid tumors. 

Phase 1 clinical trial of CDR404 in solid tumors – recruiting
The CDR404-001 trial is evaluating the safety, tolerability, pharmacokinetics, and initial signs of clinical efficacy of CDR404. This first-in-human study is an open-label, multi-center trial, investigating escalating doses of CDR404 in patients who are positive for HLA-A*02:01 with solid tumors expressing MAGE-A4. Further information can be found at NCT06402201 or contact CDR404-001_Study@CDR-Life.com.