Crescent Biopharma (CBIO) presented its pipeline and commercial strategy at a Cantor Fitzgerald conference, highlighting clinical milestones for its lead VEGF-PD-1 bispecific CR-001 and expanded combination therapy programs built through a partnership with China's Kelun-Biotech.
Crescent was assembled in October 2024 by Peter and Fairmount Funds around next-generation immuno-oncology assets. The company entered the clinic with CR-003, an integrin beta-6 Topo1i antibody-drug conjugate in-licensed via Kelun-Biotech, beginning dosing in China in the first quarter of 2024. Its internally developed PD-L1 Topo1i ADC, CR-002, is also advancing and is scheduled to enter the clinic in 2024.
CR-001 is the company's flagship VEGF-PD-1 bispecific, currently in Phase I/II testing. Crescent designed the molecule to mirror the profile of Merck's ivonescimab — the only approved PD-1/VEGF bispecific globally — while utilizing a pembrolizumab-matching PD-1 binding domain and an engineered scFv domain. Management said it can be formulated at 150 mg/ml, compared with ivonescimab's 10 mg/ml concentration, and expects a dose range of 20 mg/kg to 30 mg/kg, in line with ivonescimab's recommended Phase II dose of 20 mg/kg.
Chief Medical Officer Ellie Im said management is targeting an objective response rate between 50% and 70%, comparable to other leading PD-1 VEGF bispecifics, with second-line plus efficacy in the 10%-20% range. CR-001 is being studied across eight tumor types — non-small cell lung cancer, four gastrointestinal cancers, endometrial, ovarian and cervical cancer — with backfill cohorts of up to 12 patients per indication at each cleared dose level, including a frontline treatment-naive NSCLC cohort.
Standard-of-care combination studies are being expanded, with hundreds of patients enrolled and at least 20 to 30 per indication. Crescent said the Kelun-Biotech portfolio includes more than 10 ADCs across targets including B7H3, Nectin-4 and Claudin that may be combined with CR-001 over time, covering more than 40 indication opportunities.
"We believe in combining the next I-O backbone therapy of CR-001 with ADC assets and other modalities to benefit patients in cancer," CEO Josh Brumm said. He added that execution gains over the past year position the company to accelerate Phase III starts, particularly as competitive pressure from Chinese assets is unlikely to catch up globally before then.
Key data readouts are mapped for 2027. Comprehensive Phase I data for CR-001, monotherapy data for CR-003 and the first-line NSCLC cohort results are expected by the first quarter. Mid-2027 will bring standard-of-care combination data for CR-001 across gastrointestinal, thoracic and gynecologic cancers. Phase I/II data for CR-002 is targeted for the second half of the year. A broader update on Phase III timing, indication strategy, CR-002 status and the Kelun-Biotech relationship is expected in fall 2026.
Crescent held a market valuation of $826 million, closed at $19.34 on the session, and shares have gained more than 63% over the past year and nearly 69% year-to-date. The company reported a current ratio of 9.66 and a balance sheet holding more cash than debt.
