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.

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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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