CR-003 / Crescent Biopharma, Sichuan Kelun Pharma - LARVOL DELTA

Recent Business Highlights & Anticipated Milestones: CR-003 (The Manila Times) - "A Phase 1/2 trial of CR-003 (also known as SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. A Phase 1/2 combination trial of CR-003 and CR-001 is expected to initiate in the first half of 2027, with initial data anticipated by year-end 2027. Under the 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."

Licensing / partnership • New P1/2 trial • P1/2 data • Solid Tumor

SKB105 for Injection in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=256 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Phase 1 clinical stage (The Manila Times) - "SKB107 (RDC)[2]: The Phase 1 study is ongoing; SKB535/MK-6204 (novel ADC with potential FIC target): The Phase 1 clinical trial for SKB535 is ongoing in China; SKB445 (novel ADC with potential FIC target): The Phase 1 clinical trials for SKB445 is ongoing in China; SKB105/CR-003 (ITGB6 ADC): In January 2026, an IND application was approved by the CDE of NMPA for the treatment of advanced solid tumor. A Phase 1/2 trial is ongoing in China."

Trial status • Bone Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Non Small Cell Lung Cancer • Pancreatic Cancer • Squamous Cell Carcinoma of Head and Neck

SKB105 for Injection in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=256 | Not yet recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

New P1/2 trial • Solid Tumor

Kelun-Biotech and Crescent Biopharma Announce Strategic Partnership to Develop and Commercialize Novel Oncology Therapeutics (PRNewswire) - "The partnership involves Crescent's CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech's SKB105, an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload. Both candidates are being developed for the treatment of solid tumors and are expected to enter Phase 1/2 monotherapy clinical trials in the first quarter of 2026...In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105 in the United States, Europe and all other markets outside of Greater China."

Licensing / partnership • New P1/2 trial • Solid Tumor

…Sichuan Kelun-Biotech Biopharmaceutical…is pleased to announce that the Company’s Investigational New Drug (IND) application for SKB105 (also known as CR-003)…has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of advanced solid tumors (HKEXnews)

New trial • Solid Tumor

Crescent Biopharma Strengthens Leadership Team with Appointment of Three Key Executives (PRNewswire) - "...'Our lead asset CR-001 remains on track for IND filing in the fourth quarter of this year, with first clinical data readout anticipated in the second half of 2026. Likewise, our novel ADCs CR-002 and CR-003 remain on track, with an IND for CR-002 expected in mid-2026. We continue to expect our reverse merger with GlycoMimetics to close in the second quarter of 2025, and the addition of these new leaders, along with the wealth of industry experience they bring, ensures we are well positioned to continue our momentum and capitalize on the rich set of opportunities before us'."

Commercial • IND • Solid Tumor