Alphamab Oncology (HKG: 9966) and 3D Medicines’ envafolimab (KN035) has obtained fast-track status from the US Food and Drug Administration (FDA) for the treatment of locally advanced, unresectable, or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) that have progressed after chemotherapy. This designation is expected to accelerate the development and review process for the drug, bringing it closer to potential approval for these indications.
Innovation in PD-L1 Therapy
Envafolimab is the world’s first PD-L1 single-domain antibody and human IgG1 Fc fusion protein capable of being injected subcutaneously. It is also stable at room temperature, making it a convenient and accessible treatment option. The drug was originated by Alphamab Oncology, with 3D Medicines acting as co-development partner under a January 2019 deal.
Regulatory Milestones and Partnerships
Envafolimab was first approved in China in November last year for the treatment of adult patients with advanced solid tumors with unresectable or microsatellite instability-high (MSI-H) or deficient mismatch repair gene (dMMR). The drug has also obtained orphan drug designations in the US for use in advanced biliary tract cancer and soft tissue sarcoma. Development and commercialization rights to the drug in North America belong to US-based Tracon Pharmaceuticals Inc. (NASDQ: TCON) via a 2019 licensing deal.-Fineline Info & Tech
