Context Therapeutics gets FDA approval for clinical trials of cancer drug

On Thursday, Philadelphia-based Context Therapeutics, Inc. announced it had received clearance from the U.S. Food and Drug Administration (FDA) to begin Phase 1 clinical trials for its Investigational New Drug (IND) to treat gynecologic and testicular cancers.

The IND, called CTIM-76, a Claudin 6 CD3 T cell engaging bispecific antibody, will begin Phase 1 dose escalation expansion clinical trials in patients soon. The company said it expects to enroll the first patient in mid-2024.

“The FDA’s clearance of our IND marks an important achievement for Context, allowing us to proceed with the Phase 1 clinical program for this potentially best-in-class CLDN6-targeting therapy,” Martin Lehr, CEO of Context, said. “We look forward to the expected dosing of the first patient with CTIM-76 in the coming months, and we believe the Company is well-positioned to achieve key program milestones.”

The Phase 1 clinical trial is expected to be an open-label, dose escalation and expansion study, officials said, to evaluate the drug’s safety and efficacy in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancer. Officials said the study is expected to enroll up to 70 patients and test the safety, tolerability and pharmacokinetics of the drug, as well as its overall anti-tumor activity.

Context is a biopharmaceutical company headquartered in Philadelphia that focuses on advancing medicines for solid tumors. CTIM-76 is a bispecific antibody for CLDN6 positive solid tumors. Officials said the drug may also be effective for lung and gastric cancers. Preclinical research indicates it has the potential for convenient dosing with low immunogenicity risk.