Globenewswire·2026-01-05 12:00Core Insights - Crescent Biopharma has received regulatory clearances for its investigational new drugs CR-001 and CR-003, with plans to initiate multiple clinical trials in 2026 [1][2][3] Group 1: Regulatory Approvals - The U.S. FDA has cleared Crescent's IND for CR-001, a PD-1 x VEGF bispecific antibody [2] - Crescent's partner, Kelun-Biotech, has received IND approval for CR-003 (SKB105) from the NMPA of China [2] Group 2: Clinical Trials - The Phase 1/2 ASCEND global clinical trial for CR-001 is set to begin in the first quarter of 2026, targeting treatment-naïve and previously treated patients with various solid tumors [3] - The ASCEND trial aims to enroll up to 290 participants to assess the clinical profile of CR-001, with proof-of-concept data expected in the first quarter of 2027 [3] Group 3: Product Details - CR-001 (SKB118) is designed to block PD-1 and VEGF, aiming to enhance T cell activity against tumors and reduce blood supply to tumors [5] - CR-003 (SKB105) is an ADC targeting integrin beta-6 (ITGB6) with a topoisomerase 1 inhibitor payload, designed to minimize systemic toxicity [7] Group 4: Strategic Collaboration - Crescent has a strategic collaboration with Kelun-Biotech, granting Crescent exclusive rights to develop and commercialize CR-003 outside Greater China, while Kelun-Biotech has rights for CR-001 in Greater China [4]