SUZHOU, China, March 27, 2020 /PRNewswire/ -- Alphamab Oncology (stock code: 9966HK) announced today that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of the Company, has entered a clinical supply agreement with Pfizer Inc. ("Pfizer") to advance a clinical study to investigate KN026 in combination with Ibrance® (palbociclib), an oral CDK4/6 inhibitor, in patients with previously-treated locally advanced and/or metastatic HER2-positive breast cancer. Jiangsu Alphamab, as the study sponsor, will oversee and run the trial, and Pfizer will supply palbociclib.
Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "Through the collaboration with Pfizer, we are on the right track to investigate the combination of KN026 and a CDK4/6 inhibitor for patients with HER2-positive breast cancer as a chemo-free regimen. By combining KN026 with palbociclib, we believe it has the potential to provide more effective treatment options for patients with HER2‑positive breast cancer."
This Phase Ib/II clinical trial is a multicenter, open-label study, aiming to evaluate efficacy, safety and tolerability of KN026 in combination with palbociclib in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.
KN026 received IND approval from the National Medical Products Administration of China and U.S. Food and Drug Administration in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trials in the United States, targeting HER2 expression solid tumors cancers, such as breast cancer, gastric cancer, urothelial cancer and gynecological cancers.
KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab w/o combination with Pertuzumab. KN026 has increased binding capacity as well as better inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines. KN026 phase I trials have shown good safety and preliminary efficacy.
About Alphamab Oncology
Alphamab Oncology is a biopharmaceutical company focusing on the research and development, manufacturing and commercialization of biologics 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 platform 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 proprietary CRIB and CRAM platforms for bi-specifics and antibody mixtures, and state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA's cGMP standards.
With multiple in-house proprietary platforms for innovative biopharmaceuticals, Alphamab Oncology has built a robust pipeline in oncology/immunology to benefit cancer 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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