FDA Clears IND for Crescent Biopharma's CR-001 Targeting Solid Tumors

Reuters01-05

FDA Clears IND for Crescent Biopharma's CR-001 Targeting Solid Tumors

Crescent Biopharma Inc. has announced regulatory clearance of its Investigational New Drug $(IND)$ applications for two cancer therapies: CR-001, a PD-1 x VEGF bispecific antibody, and CR-003, an ITGB6-targeted antibody drug-conjugate $(ADC)$, both intended for the treatment of advanced solid tumors. The U.S. Food and Drug Administration (FDA) cleared the IND for CR-001, enabling Crescent to proceed with a Phase 1/2 global clinical trial expected to begin in the first quarter of 2026. Additionally, Crescent’s partner, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., received IND approval for CR-003 (also known as SKB105) from the National Medical Products Administration (NMPA) of China. The collaboration grants Crescent exclusive rights to develop and commercialize CR-003 outside Greater China, while Kelun-Biotech holds exclusive rights to CR-001 in Greater China. Four clinical trials across Crescent’s portfolio are planned to commence in 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Crescent Biopharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9619697-en) on January 05, 2026, and is solely responsible for the information contained therein.

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The U.S. Food and Drug Administration (FDA) cleared the IND for CR-001, enabling Crescent to proceed with a Phase 1/2 global clinical trial expected to begin in the first quarter of 2026. Additionally, Crescent’s partner, <a href=\"https://laohu8.com/S/002422\">Sichuan Kelun</a>-Biotech Biopharmaceutical Co., Ltd., received IND approval for CR-003 (also known as SKB105) from the National Medical Products Administration (NMPA) of China. The collaboration grants Crescent exclusive rights to develop and commercialize CR-003 outside Greater China, while Kelun-Biotech holds exclusive rights to CR-001 in Greater China. Four clinical trials across Crescent’s portfolio are planned to commence in 2026.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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