Crescent Biopharma Announces Regulatory Clearances Of IND Applications For CR-001, PD-1 X VEGF Bispecific Antibody, And CR-003, ITGB6-Targeted ADC, For Treatment Of Advanced Solid Tumors
Benzinga Newsdesk 10 months ago
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CR-001 IND cleared by U.S. FDA; Phase 1/2 ASCEND global clinical trial to evaluate CR-001 in first-line and previously treated patients on track to initiate in first quarter of 2026, with proof-of-concept data
CR-001 IND cleared by U.S. FDA; Phase 1/2 ASCEND global clinical trial to evaluate CR-001 in first-line and previously treated patients on track to initiate in first quarter of 2026, with proof-of-concept data anticipated in first quarter of 2027
Crescent partner Kelun-Biotech receives IND approval for CR-003 (SKB105) by NMPA of China
Four clinical trials across portfolio expected to initiate in 2026
WALTHAM, Mass., Jan. 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 regulatory clearances of Investigational New Drug (IND) applications for CR-001, a PD-1 x VEGF bispecific antibody, and CR-003, an integrin beta-6 (ITGB6)-targeted antibody drug-conjugate (ADC), both being developed for the treatment of advanced solid tumors.
The U.S. Food and Drug Administration (FDA) has cleared Crescent's IND for CR-001, and Crescent's partner Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") has received IND approval for CR-003 (also known as SKB105) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.