Context Therapeutics Inc. announced the selection of CTIM-76, a T cell-engaging bispecific antibody, as its lead clinical development candidate to target Claudin 6 (CLDN6) positive cancers, resulting from its research collaboration and licensing agreement with Integral Molecular. CLDN6 is differentially expressed on cancer cells with no or very low expression in normal, healthy tissue. CLDN6-enriched cancers include ovarian, endometrial, testicular, and gastric, among others.

With the potential to reach a large patient population and selective expression on cancer cells, CLDN6 has emerged as an exciting drug target. Context's lead candidate, CTIM-76, is a CLDN6 x CD3 bispecific antibody that incorporates a highly selective CLDN6 binding arm and a CD3 binding single-chain Fv domain in an IgG format with a silenced Fc that is designed to be functionally monovalent to avoid aberrant T-cell activation and to enhance the safety profile. Research has demonstrated that CTIM-76 is potent with specific lysis of CLDN6+ cancer cells over normal cells and can activate cytotoxic T cells without concomitant activation of free cytokines – critical determinants of immunotherapy safety and activity.

Preclinical studies suggest the potential for convenient dosing with low immunogenicity risk and manufacturing can be scalable to address the significant number of patients who are potentially eligible for CTIM-76 therapy.