Context Therapeutics Files IND for CTIM-76 Clinical Trial in CLDN6-Positive Tumor Patients

April 1, 2024 — Context Therapeutics Inc. (Nasdaq: CNTX), a biopharmaceutical company specializing in treatments for solid tumors, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CTIM-76. The application seeks to initiate a Phase 1 clinical trial for the treatment of patients with Claudin 6 (CLDN6)-positive gynecologic and testicular cancers. The IND submission includes comprehensive data on manufacturing, preclinical research, and toxicology to support the proposed human trial.
Martin Lehr, CEO of Context, highlighted the significance of the IND submission for CTIM-76, emphasizing the company's commitment to developing a potentially best-in-class CLDN6-targeting therapy. The company had set an ambitious timeline to advance CTIM-76 into clinical trials, prioritizing the program due to its high selectivity for CLDN6, a protein overexpressed in a variety of solid tumors.
CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody designed to target solid tumors where CLDN6 is enriched. Preclinical research indicates that CTIM-76 may offer convenient dosing with a low risk of immunogenicity and has the potential for scalable manufacturing, which could benefit a large number of patients.
Context Therapeutics is headquartered in Philadelphia and is developing CTIM-76 as part of its mission to advance medicines for solid tumors. The company's focus is on CLDN6 as a target for its selective bispecific antibody, which is currently in preclinical development. CLDN6 is a membrane protein found in multiple solid tumors but is absent or expressed at low levels in healthy adult tissues.

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