Context Therapeutics Gets FDA Approval for Phase 1 Trial of CTIM-76

Context Therapeutics Inc., a biopharmaceutical company focusing on solid tumor medicines, has announced a significant milestone. The U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application for CTIM-76, a bispecific antibody targeting Claudin 6 (CLDN6) and CD3 T cells. This approval clears the way for a Phase 1 clinical trial aimed at patients with CLDN6-positive gynecologic and testicular cancers. The company plans to begin patient enrollment in the dose-escalation phase of the trial by mid-2024.

Martin Lehr, CEO of Context Therapeutics, expressed enthusiasm about the FDA's approval, describing it as a crucial step for the company. Lehr indicated that they are eager to start dosing the first patient with CTIM-76 in the coming months. He is confident that Context Therapeutics is well-prepared to meet key milestones in the clinical program.

The upcoming Phase 1 clinical trial will be an open-label study, designed to assess both the safety and efficacy of CTIM-76. It will focus on patients with advanced or metastatic ovarian, endometrial, and testicular cancers that are CLDN6-positive. During the trial, the dose escalation and expansion phases will evaluate various parameters. These include safety, tolerability, and pharmacokinetics, as well as anti-tumor activity measured by overall response rate, duration of response, and disease control rate. The study aims to enroll up to 70 participants.

CTIM-76 is a bispecific antibody engaging both CLDN6 and CD3 T cells. CLDN6 is highly expressed in a variety of solid tumors, including ovarian, endometrial, lung, gastric, and testicular cancers. Preclinical studies suggest that CTIM-76 has the potential for convenient dosing, a low risk of immunogenicity, and scalable manufacturing, making it a viable option for many patients with CLDN6-positive tumors.

Context Therapeutics is headquartered in Philadelphia and focuses on developing treatments for solid tumors. Their lead product, CTIM-76, is a selective bispecific antibody targeting CLDN6-positive tumors. CLDN6 is a membrane protein found in multiple solid tumors but is either absent or present in low levels in healthy adult tissues. This characteristic makes it an attractive target for cancer therapy.

The approval of the IND application for CTIM-76 is a significant development for Context Therapeutics. It enables the company to initiate a Phase 1 clinical trial to explore the potential of this innovative treatment in combating CLDN6-positive gynecologic and testicular cancers. The trial's design will allow for a thorough evaluation of CTIM-76's safety and efficacy, potentially paving the way for future advancements in cancer treatment.