Context Therapeutics Begins Phase 1 Trial of CT-95 Targeting Mesothelin-Expressing Cancers

Context Therapeutics

PHILADELPHIA, PAContext Therapeutics Inc. (Nasdaq: CNTX) has announced the dosing of the first patient in its Phase 1 clinical trial of CT-95, a bispecific antibody designed to target mesothelin-expressing cancers, including ovarian, pancreatic, mesothelioma, and other solid tumors. This marks a key milestone for the company, which also recently began clinical trials for CTIM-76, another bispecific antibody targeting Claudin 6-positive cancers.

CT-95, a mesothelin x CD3 T cell engaging bispecific antibody, focuses on cancers where mesothelin, a membrane protein, is overexpressed in approximately 30% of cases but remains minimally present in normal tissues. The Phase 1 open-label trial is structured to assess safety, tolerability, pharmacokinetics, and early signs of efficacy through dose escalation and expansion phases. Up to 30 patients with advanced mesothelin-expressing tumors are expected to enroll during the dose escalation stage.

Martin Lehr, CEO of Context Therapeutics, highlighted the significance of this milestone. “Dosing of the first patient in our CT-95 Phase 1 clinical trial represents another step forward in our mission to develop next generation precision immunotherapies for solid tumors,” Lehr said.

The study aims to advance precision oncology by addressing a critical need for innovative therapies targeting difficult-to-treat cancers. Context anticipates sharing initial trial data for CT-95 by mid-2026, further strengthening its pipeline of T cell engaging bispecific antibody therapies.

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