China-based Biocytogen (Beijing) Co., Ltd and US-based Tracon Pharmaceuticals Inc. (Nasdaq: TCON) announced that the US FDA has approved an IND application to conduct a clinical trial of YH001 in combination with envafolimab or doxorubicin for sarcoma patients, including those who have not been previously treated.
Trial Design
The Phase I/II trial will focus on rare sarcoma subtypes, including alveolar soft part sarcoma and chondrosarcoma, and will assess the safety and efficacy of the combination therapy in common subtypes such as leiomyosarcoma and dedifferentiated liposarcoma.
Drug Profiles
- YH001: An IgG1 antibody targeting CTLA-4, discovered by Biocytogen and licensed to Tracon. Preclinical data suggest it may outperform Yervoy (ipilimumab).
- Envafolimab: A PD-L1 inhibitor licensed by Tracon from China’s Alphamab and co-developed with 3D Med. It is the only PD-L1 drug suitable for subcutaneous injection.
Strategic Collaboration
The partnership leverages Biocytogen’s discovery capabilities and Tracon’s oncology expertise to advance treatments for rare and common sarcoma subtypes. The trial aims to evaluate the potential of YH001 in combination therapies to improve outcomes for sarcoma patients.-Fineline Info & Tech
