Suzhou, February 11, 2022- Alphamab Oncology (stock code: 9966.HK) announced, that the company received the IND approval from the National Medical Products Administration (NMPA) for the company's innovative bispecific antibody KN052 (PD-L1/OX40 bispecific antibody) to initiate clinical trials for the treatment of advanced solid tumors. Currently, there is no PD-(L)1/OX40 bispecific antibody approved for marketing worldwide.
With recent development of immunotherapy, tumor therapy has entered a new era. KN052 is an innovative bispecific antibody developed by Alphamab Oncology using the company's bispecific antibody platform. It can simultaneously bind PD-L1 and OX40, effectively reversing tumor induced immune inhibition by blocking the PD-L1/PD-1 pathway and promoting the immune response by agonizing OX40. KN052 prevents the immune escape of tumor cell, on the other hand, it activates CTL T cells and attenuates Treg-mediated immunosuppression. Through synergistic mechanisms, KN052 is expected to exert strong antitumor efficacy.
OX40 related antibodies, monospecific or bispecific, are all in early clinical trials worldwide. In preclinical studies, KN052 showed significantly stronger activity than single antibody or in combination. Based on this IND approval, Alphamab Oncology will conduct a phase Ia/Ib clinical study of KN052 in advanced solid tumors to evaluate its safety, tolerability, PK/PD and efficacy. The study also includes expansion cohorts for appropriate tumor types at respective dose levels.
Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, “Alphamab Oncology’s leading technology platform allows us to continue to expand our product pipeline and explore next-generation anti-tumor therapies through internal R&D. KN052 is the world's first PD-L1/OX40 bispecific antibody entering clinical development. Based on its unique mechanism of action, KN052 is highly promising for solid and hematological malignancies.”
About KN052
KN052 is a PD-L1/OX40 bispecific antibody independently developed by Alphamab Oncology. It can simultaneously bind PD-L1 and OX40, effectively blocking the PD-L1/PD-1 pathway and agonizing OX40. In February 2022, the IND for KN052 was approved by the National Medical Products Administration (NMPA) to initiate Phase I clinical trials in China.
About Alphamab Oncology
Alphamab Oncology is focusing on innovation, including discovery, development, 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 a fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen anticancer monoclonal antibodies and bispecific antibodies and a Covid-19 bispecific antibody. Five products have advanced into phase I-III clinical trials in China, the United States, Japan and Australia and in November 2021, one of these products, the unique PD-L1 antibody for subcutaneous administration, Envafolimab, received marketing authorization from the Chinese National Medical Products Administration (NMPA) for the treatment of previously treated MSI-H/dMMR advanced solid tumors.
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.
