CR-002 - (APOLLO)

October 5, 2026: Crescent Biopharma (NASDAQ: CBIO) said the FDA cleared the IND for CR-002, a PD-L1-directed topoisomerase inhibitor antibody-drug conjugate, for advanced solid tumors. The company plans to start the global Phase 1/2 APOLLO trial in Q4 2026.

APOLLO is expected to enroll about 200 patients across the U.S., Europe, and Asia Pacific, with dose-escalation and tumor-specific backfill cohorts and possible expansion cohorts. Tumor types named include non-small cell lung cancer, head and neck squamous cell carcinoma, and gastrointestinal and gynecological tumors.

Initial clinical data are expected in 2H 2027 and are planned to include safety, pharmacokinetics, and preliminary antitumor activity across multiple tumor types.

Crescent said CR-002 was internally developed in collaboration with Paragon Therapeutics and also plans to evaluate CR-002 in combination with CR-001, its PD-1 x VEGF bispecific antibody.