Context Therapeutics receives US FDA clearance of IND application for phase 1 clinical trial of CTIM-76
Overview
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.
Words from CEO: Context
- “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.”
- Phase 1 clinical trial
- 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
- 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.
