Context Therapeutics Submits IND Application to Evaluate CTIM-76 in Claudin 6-Positive Cancers

Important Regulatory Milestone Supports Next Phase of CTIM-76 Development

PHILADELPHIA, April 01, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced that on March 28, 2024, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration to begin a first-in-human clinical study of CTIM-76. The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of CTIM-76 in patients with Claudin 6 (CLDN6)-positive gynecologic and testicular cancers. 

“Our IND submission for CTIM-76 is a significant milestone for Context,” said Martin Lehr, CEO of Context. “In 2021, we set an aggressive timeline to advance CTIM-76 into the clinic and we prioritized this program as we believe it is a potentially best-in-class CLDN6-targeting therapy that is highly selective for CLDN6. The IND application includes extensive manufacturing, preclinical, and toxicology data to support a first-in-human trial. I am incredibly proud of the entire Context team who worked tirelessly to complete this IND submission. We are excited to continue advancing the development of CTIM-76 and remain focused on preparing for the initiation of the Phase 1 clinical trial so that we can make CTIM-76 available to physicians and their patients as soon as possible.”

About CTIM-76
CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy.

About Context Therapeutics
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. Context is developing CTIM-76, a selective CLDN6 x CD3 bispecific antibody for CLDN6-positive tumors, currently in preclinical development. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors, including ovarian, endometrial, testicular, and lung, and absent from or expressed at low levels in healthy adult tissues. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn.