Crescent Biopharma has administered the first patient in its ASCEND Phase 1/2 trial of CR‑001, a PD‑1 x VEGF bispecific antibody designed to treat advanced solid tumors. The trial is a global, open‑label study that will enroll up to 290 patients across multiple tumor types, including non‑small cell lung cancer, gastrointestinal, and gynecological cancers, in both treatment‑naïve and previously treated patients.
The ASCEND study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. Proof‑of‑concept data are expected in the first quarter of 2027, and the results will inform the recommended Phase 2 dose and support the broader development strategy for CR‑001, including potential combination therapies with Crescent’s antibody‑drug conjugate (ADC) pipeline.
CR‑001 is engineered to combine PD‑1 checkpoint inhibition with VEGF blockade, aiming to restore T‑cell function while reducing tumor blood supply. The bispecific design is intended to replicate the cooperative pharmacology of ivonescimab, a benchmark in the field, and to position CR‑001 as a “best‑in‑class” immuno‑oncology backbone.
The first‑patient dose marks a critical operational milestone that moves CR‑001 from preclinical development into early‑phase human testing. The milestone also supports Crescent’s broader pipeline, which includes ADC candidates CR‑002 (targeting PD‑L1) and CR‑003 (targeting integrin beta‑6). A Phase 1/2 ADC combination trial with CR‑001 is planned for the second half of 2026, and the ASCEND trial is the first of four clinical studies slated to begin in 2026.
Crescent has secured a $185 million private placement that closed on December 8 2025, providing cash runway through 2028 and supporting key clinical data readouts. The company also maintains a strategic collaboration with Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd., under which Kelun has exclusive rights to develop and commercialize CR‑001 in Greater China, while Crescent retains rights to Kelun’s ADC, SKB105 (CR‑003), outside of Greater China.
Chief Medical Officer Ellie Im said the initiation of ASCEND is a significant milestone for Crescent and the development of CR‑001, adding that the company is excited to work with clinicians worldwide to improve the standard of care for cancer patients.
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