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 6:07 pm Published by

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.

Holly Hancock
MacDougall Advisors

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