Context Therapeutics Inc.

Context Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing T cell engaging (TCE) bispecific antibodies (bsAb) for solid tumors. The company aims to build a portfolio of these TCE bispecific therapeutics. Its pipeline includes CTIM-76, a Claudin 6 (CLDN6) x CD3 TCE, CT-95, a Mesothelin (MSLN) x CD3 TCE, and CT-202, a Nectin cell adhesion protein 4 (Nectin-4) x CD3 TCE. CTIM-76 is designed to redirect T-cell-mediated lysis towards malignant cells expressing CLDN6, a protein found in multiple solid tumors and at low levels or absent in healthy adult tissues. IND-enabling studies for CTIM-76 have been completed. On May 2, 2024, the U.S. Food and Drug Administration (FDA) cleared the company's IND application for a Phase 1 dose escalation and expansion trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. The first patient in this trial was dosed in January 2025. Phase 1a interim data for the CTIM-76 trial are expected in June 2026. CT-95 is an MSLN x CD3 TCE intended to redirect T-cell-mediated lysis towards malignant cells expressing MSLN, a membrane protein overexpressed in approximately 30% of cancers. The first patient in the CT-95 Phase 1 trial was dosed in April 2025. Phase 1a interim data for the CT-95 trial are expected in September 2026. CT-202 is a Nectin-4 x CD3 TCE that targets Nectin-4, a cell surface protein frequently overexpressed in various solid tumors, including bladder, colorectal, lung, and breast cancers. Nectin-4 is a clinically validated target for cancer therapy, though traditional antibody-drug conjugates (ADCs) targeting it are associated with adverse events like neuropathy and rash. CT-202 is a pH-dependent TCE designed for preferential activity within the tumor microenvironment. The company submitted an application to the Australian Bellberry Human Research Ethics Committee (HREC) in March 2026 to support the initiation of a first-in-human trial for CT-202.