Context Therapeutics (NASDAQ:CNTX) Inc has designated CTIM-76, a T cell-engaging bispecific antibody, as its lead clinical development candidate to target Claudin 6 (CLDN6) positive cancers, the company announced.
The CLDN6 gene is differentially expressed on cancer cells but has no or very low expression in normal, healthy tissue. CLDN6-enriched cancers include ovarian, endometrial, testicular, and gastric, among others.
Context’s CTIM-76 incorporates a highly selective CLDN6 binding arm. Research has shown 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).
READ: Context Therapeutics ends 3Q with a substantial $39M cash runway to advance pipeline programs
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, the company said.
“We selected this bispecific based on the specificity which suggests its potential to address the need for potent therapeutic modalities for cancer without compromising patient safety,” Context CEO Martin Lehr said in a statement.
“With the selection of CTIM-76 as our lead CLDN6 candidate, we are well-positioned to rapidly advance our clinical development plan in CLDN6-positive tumors including, but not limited to, ovarian cancer. We have initiated IND-enabling studies and expect to submit our Investigational New Drug Application for CTIM-76 to the US Food and Drug Administration in Q1 2024.”
The company collaborated with Integral Molecular on the research.
“Despite being an attractive target, therapeutic monoclonal antibodies targeting CLDN6 are difficult to discover due to an abundance of closely related family members and an absolute need for high specificity,” said Joseph Rucker, vice president of R&D at Integral Molecular.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
Follow him on Twitter @andrew_kessel