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        English 中文簡體 中文繁體

        IND Application for Pivotal Clinical Study of PD-L1/CTLA-4 Bispecific Antibody KN046 for PD-(L)1 Refractory NSCLC was Approved by CDE

        September 23, 2021 16:34 Eastern Daylight Time

        Suzhou, China, September 23, 2021 - Alphamab Oncology (stock code: 9966.HK), announced that a new IND application for the company’s proprietary recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046 was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), to initiate a multi-center, open-label, randomized-controlled phase II/III pivotal clinical study (ENREACH-LUNG-02/KN046-302) to evaluate the efficacy, safety, and tolerability of KN046 combined with lenvatinib versus docetaxel in patients with advanced NSCLC  who have progressed on anti-PD-(L)1 treatment. This is the third pivotal clinical study of KN046 after the first one in treatment naïve squamous NSCLC and the second one in thymic carcinoma.

         

        Lung cancer is the most fatal malignant tumor both in China and worldwide. According to the 2020 global cancer data from the International Agency for Research on Cancer (IARC) of the World Health Organization, Lung cancer accounts for over 18% of all cancer-related deaths worldwide, more than any other cancer type. In China, there are 820,000 new cases and 710,000 deaths each year, both rates ranked first. NSCLC accounts for approximately 85% of all lung cancers. For NSCLC patients with negative driver mutations, the standard of care is anti-PD-1 monotherapy (PD-L1 expression ≥50%) or in combination with platinum-based chemotherapy, but more than 70% of patients progressed on first-line anti-PD-(L)1 treatment. There is no effective option for PD-(L)1 refractory NSCLC patients, thus there are huge unmet needs.

         

        KN046 is a tetravalent bispecific antibody that simultaneously recognizes PD-L1 and CTLA-4. It can more effectively prime and activate T cells. KN046 has shown good safety and potential clinical benefits in two clinical studies for the treatment of patients who failed prior immune checkpoint inhibitor therapy.

         

        The ENREACH-LUNG-02/KN046-302 study will enroll patients with locally advanced unresectable or metastatic NSCLC who progressed on anti-PD-(L)1 treatment. It is an open-label, randomized controlled multi-center study, with OS and PFS as co-primary endpoints.

         

        Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, “Lung cancer is a huge global health threat. In recent years, immunotherapy has been changing the paradigm of NSCLC treatment, but there is still no effective treatment in patients who progressed on anti-PD-(L)1 treatment. Several clinical studies have shown that KN046 has the potential to become the cornerstone drug of the immuno-oncology therapy in the post-PD-(L)1 era. In a prospective clinical study in patients who failed prior immune checkpoint inhibitor therapy, KN046 monotherapy achieved positive PFS and OS data. By initiating this pivotal clinical study, we hope to further confirm the efficacy of KN046 in PD-(L)1 refractory advanced NSCLC patients and bring hope to patients in need.”

         

        About KN046

        KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a different mechanism CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg(suppress tumor immunity) clearing function.

         

        There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab has received FDA clearance to enter phase Ⅱ trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA's orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.

         

        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 bispecific 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.