Crescent Biopharma (NASDAQ: CBIO) received FDA approval to launch a Phase 1/2 study of its PD‑1 × VEGF bispecific antibody, CR‑001, and its partner, Sichuan Kelun‑Biotech, obtained National Medical Products Administration clearance for the integrin‑beta‑6‑targeted antibody‑drug conjugate, CR‑003 (SKB105). The approvals unlock a global portfolio of four clinical trials slated to begin in 2026, including the ASCEND study of CR‑001 in patients with a range of solid tumors.
CR‑001 combines checkpoint inhibition with anti‑angiogenic activity, aiming to restore T‑cell function while cutting off tumor blood supply. The ASCEND trial will enroll up to 290 participants across multiple tumor types—non‑small cell lung cancer, gastrointestinal, and gynecological cancers—and is scheduled to start in the first quarter of 2026. The dual‑mechanism design is intended to broaden the therapeutic window and accelerate the path to regulatory approval.
CR‑003 is a novel antibody‑drug conjugate that targets integrin‑beta‑6, a protein overexpressed in many solid tumors. Kelun‑Biotech’s NMPA clearance allows the drug to enter clinical development in China, while Crescent retains rights in the U.S., Europe, and other markets. The partnership structure gives each company access to the other’s geographic strengths and accelerates the global launch of the four planned trials.
The regulatory clearances are a critical milestone for Crescent’s pipeline and validate the company’s strategy of partnering to expand geographic reach. The approvals follow a December 2025 partnership announcement that included a $185 million private placement, which provided the capital needed to advance the clinical program. By securing IND status in both the U.S. and China, Crescent positions itself to generate early safety and efficacy data that will inform later‑stage development and potential commercialization.
Ellie Im, M.D., Crescent’s chief medical officer, said the approvals “give us strong momentum to begin 2026 with four clinical trials across our portfolio, starting with the ASCEND study of CR‑001.” The statement underscores the company’s confidence in its pipeline and the importance of the partnership in accelerating development timelines.
Investors view the IND clearances as a positive step toward bringing new oncology therapies to market, reinforcing Crescent’s growth narrative and supporting the company’s long‑term value proposition.
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