Context Therapeutics Bags US FDA Nod of IND Application

Context Therapeutics Inc, a biopharmaceutical firm creating therapies for solid tumors based in Philadelphia, reported that the US FDA has approved its Investigational New Drug application for CTIM-76, a bispecific antibody that targets Claudin 6 (CLDN6) and CD3 T cells. 

The IND supports the start of a phase 1 dose-escalation and expansion clinical trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular malignancies. The company expects to enroll the first patient in the dose escalation phase of its clinical study in mid-2024.

“The US FDA’s clearance of our IND marks an important achievement for Context, allowing us to proceed with the phase 1 clinical programme for this potentially best-in-class CLDN6-targeting therapy,” said Martin Lehr, CEO of Context. “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 programme milestones.”

The phase 1 clinical trial will be an open-label, dose-escalation and expansion research to assess the safety and efficacy of CTIM-76 in people with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancer.

The trial's dose escalation and dose expansion phases are anticipated to assess anti-tumor activity by looking at overall response rate, duration of response, and disease control rate in addition to safety, tolerability, and pharmacokinetics. Up to 70 participants are anticipated to enroll in the research.