PHILADELPHIA, PA — Context Therapeutics Inc. (Nasdaq: CNTX) has announced that new research on its clinical asset, CT-95, will be unveiled at the American Association for Cancer Research (AACR) Annual Meeting 2025. The meeting, scheduled for April 25-30 in Chicago, IL, will provide a platform for Context to present key data on CT-95, a bispecific T cell engager (TCE) targeting mesothelin (MSLN) and CD3, as it moves closer to first-in-human clinical trials.
The data presentation will emphasize the method used to determine the initial clinical dose for CT-95. Context employed the minimal anticipated biological effect level (MABEL) approach, which is designed to ensure safety in first-in-human studies for immune agonist drugs. Based on this analysis, the proposed starting dose of 0.1 μg/kg is expected to safely initiate a minimal biological effect in humans.
CT-95 represents a novel innovation in cancer immunotherapy. This fully humanized bispecific TCE redirects T-cell activity against malignant cells that overexpress mesothelin, a protein found in approximately 30% of cancers. One of the key challenges in targeting mesothelin has been the presence of soluble or “shed” MSLN fragments in both the blood and tumor microenvironment. These fragments can act as a decoy, reducing the efficacy of MSLN-targeted therapies. CT-95 is engineered with a moderate affinity but high avidity for membrane-bound MSLN, which is designed to circumvent this issue and enhance its therapeutic impact.
The poster, titled Determination of first in human dose of the T cell-redirecting bispecific antibody CT-95 targeting mesothelin, will be presented on Monday, April 28, 2025, from 9:00 a.m. to 12:00 p.m. CT at the AACR Annual Meeting. This session, focused on therapeutic antibodies, will provide new insights into the potential of CT-95 to address cancers with high mesothelin expression.
With CT-95, Context Therapeutics is taking a significant step toward addressing challenges in cancer immunotherapy while advancing innovative approaches to improve patient outcomes. The research presented at AACR 2025 is expected to contribute to the broader understanding of T cell-based therapies and their role in cancer treatment.
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