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GlobeNewswire·

Crescent Biopharma Announces Clinical Pipeline Momentum, including Enrolling Patients in Standard of Care Chemotherapy Combination Cohorts of Global Phase 1/2 ASCEND Trial of CR-001, a PD-1 x VEGF Bispecific Antibody, and Initiation of Additional ADC Combination Studies with CR-001

CBIO
  • More than 125 patients have been dosed in the ASCEND trial across the United States, Europe, and South Korea with dose escalation complete
  • Initial monotherapy data from ASCEND is on track for reporting in Q1 2027, including antitumor response for a first-line NSCLC cohort
  • Patients are currently enrolling in ASCEND expansion cohorts combining CR-001 with standard of care chemotherapy for various solid tumors including NSCLC, colorectal, biliary tract, gastric, and endometrial cancers
  • Initial data from hundreds of patients in the ASCEND chemotherapy combination cohorts is expected in mid-2027
  • The first of multiple Phase 3 studies for CR-001 is anticipated to start in early 2028
  • Over 700 patients are participating in ongoing Phase 2 studies of sacituzumab tirumotecan (sac-TMT) plus CR-001, with initial data expected in mid-2027
  • Global Phase 1/2 APOLLO trial for CR-002, a PD-L1-targeted ADC, is on track to commence dosing this quarter with initial data expected in the second half of 2027
  • Phase 1/2 trial of CR-003 (SKB105), an ITGB6-targeted ADC, is ongoing in China with initial data expected in Q1 2027
  • Crescent Biopharma anticipates dosing more than 2,000 patients across its entire portfolio by mid-2027
  • CR-001 is being developed in collaboration with Kelun-Biotech, which holds exclusive rights to the asset in Greater China while both companies retain independent combination development rights