Alphamab Oncology announced the study design of the ENVASARC pivotal trial in the U.S. of Envafolimab (KN035), a recombinant humanized PD-L1 single domain antibody independently invented by Alphamab Oncology, will be presented by Alphamab's partner TRACON Pharmaceuticals in a Poster session at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021), being held June 4-8.

ENVASARC: A Pivotal Trial of Envafolimab, and Envafolimab in Combination with Ipilimumab, in Patients with Advanced or Metastatic Undifferentiated Pleomorphic Sarcoma or Myxofibrosarcoma who have Progressed on Prior Chemotherapy
Abstract No.: TPS11581
Session Category: Sarcoma
First author: Sandra P. D'Angelo, MD. Memorial Sloan Kettering Cancer Center

The ENVASARC (NCT 04480502) pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study being conducted at approximately 25 top cancer centers in the United States, that is expected to enroll a total of 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Ipilimumab. The primary endpoint is objective response rate (ORR) by blinded independent central review with duration of response a key secondary endpoint.

About Envafolimab (KN035)

Envafolimab (KN035) is a single domain Fc fusion PD-L1 antibody independently invented by Alphamab Oncology. Based on its unique design that allows rapid subcutaneous injection, it has advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not require an intravenous infusion which lowers medical costs. On December 20, 2019, Alphamab Oncology, 3D Medicines, and TRACON Pharmaceuticals reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and TRACON is responsible for the clinical development and commercialization of KN035 for the treatment of soft tissue sarcomas in North America.

At present, Envafolimab (KN035) has been studied in clinical trials for multiple tumor indications in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab (KN035) obtained orphan drug designation from the US FDA for advanced biliary tract cancer and the National Medical Products Administration (NMPA) accepted the biologic license application (BLA) for Envafolimab (KN035) in MSI-H/dMMR cancer and granted priority review.

About Alphamab Oncology

Alphamab Oncology is focusing on innovation, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong, S.A.R., China Stock Exchange with stock code 9966.

Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).

The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA's cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.