Context announces FDA clearance of IND application for Phase 1 trial of CTIM-76

Context Therapeutics announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, application for CTIM-76, a Claudin 6 x CD3 T cell engaging bispecific antibody. The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. The Company anticipates the enrollment of the first patient in the dose escalation portion of its clinical trial 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,” 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 program milestones.”