CDR-Life Starts CDR404 Phase 1 Trial for Solid Tumors at ASCO

ZÜRICH--CDR-Life Inc., a biopharmaceutical company focused on developing precision immunotherapies, has commenced patient enrollment for the Phase 1 clinical trial of their leading program, CDR404. This study represents a critical step in evaluating CDR404's efficacy as a groundbreaking treatment for solid tumors. The trial's initiation follows significant regulatory milestones, including the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) and a subsequent Clinical Trial Application (CTA) approval in Denmark.

CDR404, the centerpiece of CDR-Life's research, is an innovative antibody-based bivalent and bispecific MAGE-A4 T-cell engager (TCE). This therapy is designed specifically to target MAGE-A4 positive solid tumors, utilizing the company's proprietary M-gager® technology. The unique approach of CDR404 aims to precisely engage T-cells to identify and destroy cancer cells expressing the MAGE-A4 antigen, a marker associated with various solid tumors.

The ongoing Phase I trial of CDR404 is actively recruiting participants at multiple locations across the United States and Europe. This multinational study aims to assess the safety, tolerability, and preliminary efficacy of the novel TCE in patients with solid tumors, particularly focusing on its potential in tackling hard-to-treat cancers.

An exciting development for CDR-Life is the acceptance of an abstract for online presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for May 31 - June 4 in Chicago, Illinois. The ASCO abstract highlights key findings from a study that evaluated biomarkers predictive of CDR404's effectiveness against non-small cell lung cancer (NSCLC) tumors.

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

CDR-Life is at the forefront of developing T-cell engagers (TCEs) to combat difficult-to-treat solid tumors. Their integrated antibody-based TCE platform provides access to a broad spectrum of cancer antigens, allowing the company to advance a pipeline of highly selective and potent TCE therapeutics. These therapeutics target both intracellular and surface tumor antigens, leveraging the body's own immune system to eradicate tumors.

The company's team comprises seasoned experts in drug development and is supported by a robust group of cross-Atlantic investors. With this backing, CDR-Life aims to empower patients by harnessing their immune systems to fight cancer more effectively.

As CDR-Life continues to push the boundaries of cancer treatment, the initiation of the Phase 1 trial for CDR404 marks a significant milestone in their mission to develop innovative and accessible cancer therapies. The upcoming presentation at the ASCO Annual Meeting will further shed light on the potential of CDR404 and its role in the future of cancer treatment.

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