Crescent Biopharma receives FDA IND clearance for CR-002 in Solid tumors

CAR-T Digest - August 2020

Weekly Digest - October 2026

05 October 2026: Crescent Biopharma receives FDA IND clearance for CR-002 in Solid tumors

Crescent Biopharma announced that the U.S. FDA has cleared the Investigational New Drug application for CR-002, its investigational PD-L1-targeted topoisomerase inhibitor antibody-drug conjugate, enabling clinical development in patients with advanced solid tumors
CR-002 will be evaluated in the global Phase 1/2 APOLLO trial, planned to initiate in Q4 2026, with approximately 200 patients expected across dose-escalation and tumor-specific cohorts. The study will include multiple tumor types, such as non-small cell lung cancer, head and neck squamous cell carcinoma, and gastrointestinal and gynecological cancers, with initial clinical data anticipated in the second half of 2027
The program aims to address unmet needs across advanced solid tumors, where treatment resistance and disease progression continue to drive demand for new targeted therapies, particularly in tumors expressing PD-L1
CR-002 is designed to combine a highly internalizing PD-L1-targeting antibody with a topoisomerase inhibitor payload, using a linker intended to remain stable in circulation and enable intracellular payload release. The approach is intended to concentrate cytotoxic activity within tumor cells while limiting premature payload release
Strategically, CR-002 becomes the third distinct Crescent Biopharma program to enter clinical development, expanding its ADC portfolio alongside its PD-1 × VEGF bispecific antibody, CR-001. Crescent also plans to evaluate CR-002 in combination with CR-001, reflecting its broader strategy of integrating ADCs with immuno-oncology approaches across solid tumors