CDR-Life Presents Precise Tumor and Patient Selection for CDR404: First-of-its-Kind Dual MAGE-A4 T-cell Engager, at ESMO Congress 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, Oct. 23, 2023 (GLOBE NEWSWIRE) -- 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.”
- High levels of MAGE-A4 expression are present in different-sized sub-groups across a wide range of solid cancers with high unmet medical needs 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 indicate, 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
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.To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
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