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Crescent Biopharma Announces Regulatory Clearances of IND Applications for CR-001, a PD-1 x VEGF Bispecific Antibody and CR-003, an ITGB6-targeted ADC, for the Treatment of Solid Tumors
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
About this update from Crescent Biopharma, Inc.
[{"type":"text","content":"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. “With regulatory clearances for CR-001 and CR-003, we are excited to begin 2026 with strong momentum as we work to deliver next generation therapies for people living with cancer,” said Ellie Im, M.D., chief medical officer of Crescent. “We are on track to have four clinical trials initiate across our portfolio in 2026, starting with the ASCEND trial of CR-001 planned for this quarter. Based on its intentional design replicating a clinically validated approach and robust preclinical profile demonstrating cooperative pharmacology and anti-tumor activity, we believe CR-001 has the potential to be a best-in-class therapy and immuno-oncology backbone.” The Phase 1/2 ASCEND global clinical trial plans to enroll both treatment-naïve and previously treated patients with multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological tumors. The trial is expected to enroll up to 290 participants in the dose-escalation, back-fill and dose-optimization cohorts designed to enable robust assessment of the clinical profile of CR-001. Crescent anticipa...