FDA clears Crescent Biopharma IND for CR-002 solid tumor ADC

Crescent Biopharma, Inc. (Nasdaq: CBIO) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for CR-002, a topoisomerase inhibitor antibody-drug conjugate targeting programmed cell death ligand 1 (PD-L1), intended for the treatment of advanced solid tumors.

The company said the Phase 1/2 APOLLO global clinical trial is on track to begin in the fourth quarter of 2026, with initial clinical data expected in the second half of 2027. The trial plans to enroll patients across the United States, Europe, and Asia Pacific with tumor types including non-small cell lung cancer, head and neck squamous cell carcinoma, and various gastrointestinal and gynecological tumors.

The dose escalation and tumor-specific backfill cohorts are expected to enroll approximately 200 participants, with the possibility of additional participants in expansion cohorts. Crescent said it anticipates reporting safety, pharmacokinetic, and preliminary antitumor activity data from the trial across multiple tumor types.

CR-002 was developed internally in collaboration with Paragon Therapeutics. According to a statement from Crescent's chief medical officer, Ellie Im, M.D., the IND clearance represents the third program in the company's portfolio to enter the clinic.

Crescent also said it plans to evaluate CR-002 in combination with CR-001, its PD-1 x VEGF bispecific antibody, as part of efforts to assess ADC and immuno-oncology combinations.

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