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        Poster to Highlight ENVASARC Pivotal Trial of Envafolimab (KN035) will be presented at the 2021 ASCO Annual Meeting

        May 24, 2021 08:11 Eastern Daylight Time

        Suzhou, May 24, 2021 - Alphamab Oncology (stock code: 9966.HK) 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 (" TRACON", NASDAQ: TCON) 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 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.


        Alphamab Oncology Forward-Looking Statements

        This press release contains statements related to our future business and financial performance and future events or developments involving Alphamab Oncology that may constitute forward-looking statements. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. We may also make forward-looking statements in other reports, in presentations, in material delivered to shareholders and in press releases. In addition, our representatives may from time to time make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Alphamab Oncology’s management and business operation, many of which are difficult to predict and generally beyond Alphamab Oncology’s control. These are subject to a number of risks and uncertainties, including but not limited to, uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Alphamab Oncology's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding and Alphamab Oncology’s disclosures. Should one or more of these risks or uncertainties materialize or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. Other than as required by applicable law, Alphamab Oncology undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.