China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving approval from the US FDA to conduct a single-arm, multi-center Phase II study assessing the safety and efficacy of envafolimab (KN035) in treating deficient mismatch repair (dMMR) advanced solid tumors. The study will involve one subcutaneous injection every three weeks.
About Envafolimab
Envafolimab is the world’s first PD-L1 single-domain antibody and human IgG1 Fc fusion protein capable of subcutaneous injection. It is also stable at room temperature. The drug was originated by Alphamab Oncology (HKG: 9966), with 3D Medicines acting as a co-development partner under a January 2019 deal. Envafolimab was previously approved in November last year for treating adult patients with microsatellite instability-high (MSI-H) or dMMR-positive tumors. It has also obtained orphan drug designations in the US for use in advanced biliary tract cancer and soft tissue sarcoma.
Development and Commercialization Rights
The development and commercialization rights to envafolimab in North America belong to US-based Tracon Pharmaceuticals Inc. (Nasdaq: TCON) through a 2019 licensing deal. This strategic partnership aims to accelerate the global development and commercialization of envafolimab, positioning it as a potential new treatment option for patients with advanced solid tumors.-Fineline Info & Tech
