Alphamab Oncology announced that Jiangsu Alphamab Biopharmaceuticals Co., Ltd., a wholly-owned subsidiary of the Company, received Safe to Proceed Letter from the US Food & Drug Administration for its recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046, to initiate Phase II clinical trial in anti-PD-1 refractory or relapsed Non-Small-Cell Lung Cancer.
SUZHOU, China, April 16, 2020 /PRNewswire/ -- Alphamab Oncology (stock code: 9966 HK) announced today that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab”), a wholly-owned subsidiary of the Company, received Safe to Proceed Letter from the US Food & Drug Administration (“FDA”) for its recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046, to initiate Phase II clinical trial in anti-PD-(L)1 refractory or relapsed Non-Small-Cell Lung Cancer (“NSCLC”). KN046’s Phase I clinical trials in Australia and China, along with multiple Phase II trials in China have shown a good safety profile and promising efficacy.
KN046 is a global first-in-class programmed death ligand 1 (“PD-L1")/ cytotoxic T-lymphocyte-associated protein 4 (“CTLA-4") bispecific antibody developed by the Jiangsu Alphamab. PD-(L)1 and CTLA-4 are the only two clinically validated immune checkpoints, and their combo therapy has been approved for the treatment of melanoma, colorectal cancer and kidney cancer, but application of the combo therapy has limited application due to its toxicity. Through innovative drug design, Jiangsu Alphamab has fused a novel CTLA-4 single-domain antibody with PD-L1 antibody to form KN046, a bispecific antibody with acceptable safety. KN046 has the capacity to block both PD-(L)1 and CTLA-4, effectively activate T-cells and strengthen anti-tumor immune activity.
KN046 is the only anti-PD-L1/CTLA-4 bispecific antibody drug in clinical development phase globally, and also Jiangsu Alphamab’s third drug candidates which have been approved to enter clinical trial in the United Sates. KN046 is currently undergoing multiple Phase II clinical trials for NSCLC, triple-negative breast cancer (“TNBC”), esophageal squamous cell carcinoma (“ESCC”) and pancreatic cancer. The result from these clinical trials is scheduled to be released in various occasions including international medical conferences. This Phase II clinical trial in the United States aims to evaluate the safety, tolerability and efficacy of KN046 monotherapy or in combination with chemotherapy in locally advanced unresectable or metastatic NSCLC.
Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, “We are unwaveringly committed to providing world class therapeutic biologics to global patients. Represented by KN046, our innovative bispecific antibodies pipeline has given us a head start to fulfill this mission. The IND approval from FDA is an important milestone for KN046’s the global development. We will accelerate clinical development on multiple oncology indications, and work hard towards an earlier market launch and provide cancer patients with a safe and more effective treatment option.”
About KN046
KN046 is the world’s first recombinant humanized PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a proprietary CTLA-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with PD-L1 antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg clearing function. The preclinical and clinical study results of KN046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become the backbone of next generation immuno-oncology therapy in the future.
Previously, KN046’s phase I clinical trials in Australia and China have shown a preliminary profile of good safety and promising efficacy, and several phase II clinical trials are ongoing in China for NSCLC, TNBC, ESCC and pancreatic cancer.
About Alphamab Oncology
Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. 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 consists of eight anti-cancer drug candidates, four of which have advanced into Phase I – III clinical development phases in China, US and Japan.
The Company also has state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA’s cGMP standards.
Alphamab Oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world.
Visit http://www.alphamabonc.com for more information.
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.
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SOURCE Alphamab Oncology
Company Codes: HongKong:9966
