On April 2, 2026 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to CTIM-76, a CLDN6 x CD3 T cell engaging bispecific antibody, for the treatment of platinum-resistant ovarian cancer ("PROC") in patients that have received all standard of care therapies.

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Context is currently evaluating CTIM-76 in a Phase 1 clinical trial designed to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial and testicular cancers. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability and pharmacokinetics, as well as anti-tumor activity by overall response rate, duration of response and disease control rate.

"We are pleased to receive Fast Track Designation for CTIM-76, which underscores its potential to improve the lives of patients with platinum-resistant ovarian cancer," said Karen Chagin, M.D., Chief Medical Officer of Context. "This designation is an important step forward in our goal to quickly and efficiently advance CTIM-76 through clinical development and we look forward to sharing interim data for this program in June 2026."

The FDA’s Fast Track Designation program is designed to expedite the development and review timelines of drugs that demonstrate the potential to treat serious conditions, aiming to deliver therapeutics to patients more quickly in areas of unmet need.

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. More information about the CTIM-76 clinical trial (NCT06515613) can be found on View Source

(Press release, Context Therapeutics, APR 2, 2026, View Source [SID1234664167])