Crescent Biopharma Announces FDA Clearance of IND Application for CR-002, a PD-L1-targeted Topoisomerase Inhibitor ADC, for the Treatment of Solid Tumors
Key Highlights
- ➤FDA cleared Crescent Biopharma’s CR-002 IND for advanced solid tumor treatment
- ➤APOLLO Phase 1/2 trial targeting approximately 200 participants starts in Q4 2026
- ➤Initial APOLLO clinical data expected in the second half of 2027
- ➤CR-002 will be evaluated across NSCLC, HNSCC, gastrointestinal and gynecological tumors
Expert Statements
Ellie Im, Chief Medical Officer of Crescent Biopharma
“FDA clearance of the CR-002 IND is an important milestone for Crescent and is the third distinct program in our portfolio to enter the clinic.”
Ellie Im, Chief Medical Officer of Crescent Biopharma
“The strong scientific rationale and encouraging preclinical profile of CR-002 underscores its promise in addressing a range of solid tumors.”
Ellie Im, Chief Medical Officer of Crescent Biopharma
“We look forward to initiating the APOLLO trial this quarter and working with global investigators to generate important clinical insights and advance our mission of bringing new treatment options to patients living with difficult-to-treat cancers.”
Phase 1/2 APOLLO global clinical trial to evaluate CR-002 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC), on track to initiate in the fourth quarter of 2026
WALTHAM, Mass., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CR-002, a topoisomerase inhibitor antibody drug-conjugate (ADC) targeting programmed cell death ligand 1 (PD-L1), being developed for the treatment of advanced solid tumors.
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