On January 05, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported regulatory clearances of Investigational New Drug (IND) applications for CR-001, a PD-1 x VEGF bispecific antibody, and CR-003, an integrin beta-6 (ITGB6)-targeted antibody drug-conjugate (ADC), both being developed for the treatment of advanced solid tumors.

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The U.S. Food and Drug Administration (FDA) has cleared Crescent’s IND for CR-001, and Crescent’s partner Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") has received IND approval for CR-003 (also known as SKB105) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.

"With regulatory clearances for CR-001 and CR-003, we are excited to begin 2026 with strong momentum as we work to deliver next generation therapies for people living with cancer," said Ellie Im, M.D., chief medical officer of Crescent. "We are on track to have four clinical trials initiate across our portfolio in 2026, starting with the ASCEND trial of CR-001 planned for this quarter. Based on its intentional design replicating a clinically validated approach and robust preclinical profile demonstrating cooperative pharmacology and anti-tumor activity, we believe CR-001 has the potential to be a best-in-class therapy and immuno-oncology backbone."

The Phase 1/2 ASCEND global clinical trial plans to enroll both treatment-naïve and previously treated patients with multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological tumors. The trial is expected to enroll up to 290 participants in the dose-escalation, back-fill and dose-optimization cohorts designed to enable robust assessment of the clinical profile of CR-001. Crescent anticipates reporting proof-of-concept clinical data from the ASCEND trial in the first quarter of 2027, including safety, pharmacokinetic, pharmacodynamic and early anti-tumor activity in first-line and previously treated patients.

In December 2025, Crescent announced a strategic collaboration with Kelun-Biotech for CR-001 and CR-003 (SKB105). Under the terms of the strategic collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105) in the United States, Europe and all markets outside of Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Crescent granted Kelun-Biotech exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China.

About CR-001 (also known as SKB118)

CR-001 (SKB118) is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. ASCEND, a global Phase 1/2 trial of CR-001 in patients with solid tumors, is anticipated to commence in the first quarter of 2026. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with Crescent’s antibody-drug conjugates (ADCs) in development. The first Phase 1/2 ADC combination trial with CR-001 is expected to initiate in the second half of 2026.

About CR-003 (also known as SKB105)

CR-003 (SKB105) is a differentiated ADC targeting integrin beta-6 (ITGB6) with a topoisomerase 1 inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. CR-003 (SKB105) incorporates proprietary Kthiol irreversible conjugation technology, linking anti-ITGB6 fully human IgG1 monoclonal antibody to a clinically validated cleavable linker. The design aims to enhance stability and tumor-specific payload delivery while reducing adverse effects. In preclinical models, CR-003 (SKB105) demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile.

(Press release, Crescent Biopharma, JAN 5, 2026, View Source [SID1234663675])