Crescent Biopharma Receives Regulatory Approval for CR-001 and CR-003, Aiming for Advances in Cancer Treatment
WALTHAM, Mass., January 05, 2026 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a clinical-stage biotechnology company, has announced significant regulatory clearances for its Investigational New Drug (IND) applications concerning CR-001 and CR-003. These therapies are particularly focused on the treatment of advanced solid tumors, representing a major advancement in cancer treatment strategies.
Regulatory Approvals Overview
The U.S. Food and Drug Administration (FDA) has granted approval for Crescent's IND application for CR-001, a bispecific antibody that targets both PD-1 and VEGF. Concurrently, Crescent's partner, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has received IND approval for CR-003 (also known as SKB105) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).
Implications of Regulatory Clearances
Dr. Ellie Im, Chief Medical Officer of Crescent, expressed enthusiasm about the approvals, stating, "With regulatory clearances for CR-001 and CR-003, we are excited to begin 2026 with strong momentum."
The company is planning to initiate four clinical trials in 2026, with the ASCEND trial for CR-001 set to start in the first quarter of 2026. Initial proof-of-concept data is expected in early 2027.
Details of the ASCEND Trial
The Phase 1/2 ASCEND clinical trial aims to recruit patients with multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological tumors. The trial will focus on:
- Enrolment of up to 290 participants
- Evaluating treatment in both treatment-naïve and previously treated patients
- Assessing safety, pharmacokinetics, pharmacodynamics, and early anti-tumor activity
Data from the ASCEND trial will allow for a comprehensive evaluation of CR-001's clinical profile.
Understanding CR-001 and CR-003
About CR-001 (SKB118)
CR-001 is a tetravalent bispecific antibody targeting PD-1 and VEGF, designed to enhance T cell activity against tumors while limiting blood supply to tumors. In preclinical studies, CR-001 exhibited effective anti-tumor action with a promising safety profile. The combination therapy potential with other antibody-drug conjugates (ADCs) further bolsters its clinical significance.
About CR-003 (SKB105)
CR-003, a differentiated ADC, targets integrin beta-6 (ITGB6) and utilizes a topoisomerase 1 inhibitor payload. This targeted approach reduces systemic toxicity, making it potentially safer for patients. Preclinical data has shown that CR-003 (SKB105) offers promising efficacy and stability.
Crescent Biopharma's Vision and Future
Crescent Biopharma aims to lead in oncology by innovating therapies that offer improved outcomes for cancer patients. The company’s clinical-stage pipeline includes CR-001 and CR-003, and other potential transformative therapies designed for solid tumors. For ongoing updates, visit Crescent Biopharma’s website.
Forward-Looking Statements
This announcement includes forward-looking statements regarding Crescent Biopharma’s future plans and pipeline developments. These include expectations related to successful trial initiation, assessment, and regulatory progress for both CR-001 and CR-003.