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Philadelphia-headquartered Context Therapeutics Inc, a biopharmaceutical company advancing medicines for solid tumors, announced that the US FDA has cleared its Investigational New Drug application for CTIM-76, a Claudin 6 (CLDN6) 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 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 is expected to be an open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancer. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity by overall response rate, duration of response, and disease control rate. The study is expected to enroll up to 70 patients.
CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy.
Context’s clinical stage product candidate, CTIM-76, is a selective CLDN6 x CD3 bispecific antibody for CLDN6-positive tumours. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors, including ovarian, endometrial, testicular, and lung, and absent from or expressed at low levels in healthy adult tissues.
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