English 中文简体 中文繁体

Alphamab Oncology will Present Phase I Clinical Data of KN046 and KN026 at the 2020 ASCO Annual Meeting

May 14, 2020 12:55 Eastern Daylight Time

Suzhou, May 14, 2020 - Alphamab Oncology (stock code: 9966 HK) announced today that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab”), a wholly-owned subsidiary of the Company, has achieved promising results for the Phase I clinical trials of KN046 (PD-L1/CTLA4 bispecific antibody) and KN026 (HER2 bispecific), these clinical data will be presented at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.


ASCO is the world’s largest and unarguably the most influential oncology organization. The ASCO Annual Meeting brings together tens of thousands of oncology professionals from around the world each year and is widely recognized as one of the world's most important oncology conferences. Due to the outbreak of COVID-19, 2020 ASCO annual meeting will take place online. Jiangsu Alphamab will present:


Title: The preliminary efficacy and safety data of KN046 (bispecific anti-PD-L1/CTLA4) in patients failed on prior immune checkpoint inhibitors therapy

Abstract No.:#3020

Time: May 29, 2020, 8:00 AM – 11:00 AM, EDT


Title: Preliminary Safety, Efficacy and Pharmacokinetics Results of KN026, a HER2-targeted Bispecific Antibody in Patients with HER2-positive Metastatic Breast Cancer

Abstract No.:#1041

Time: May 29, 2020, 8:00 AM – 11:00 AM, EDT


Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, said: "KN046 and KN026 are innovative biological drug candidates developed using our two bispecifics platforms. We are pleased to see that the latest clinical data further validate the safety and efficacy of KN046 and KN026, and that will continue to support the development of subsequent clinical trials. Currently, PD-1 is only effective in less than 30% solid cancer patients. Patients who fail to respond to PD-1 only have very limited options. We will further validate the efficacy of K046 as monotherapy and combos with other drugs in late stage cancer patients who have failed PD-1 treatments. For KN026, based on the favorable efficacy, we will conduct clinical trials as first line therapy in HER2-positive solid tumors as soon as possible. We look forward to bringing these two promising innovative oncology drugs to market soon, and making these new treatment options available to patients globally.”


KN046 is the world's first recombinant humanized PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. It is currently in Phase II clinical trials in China and the United States, with results showed that KN046 is in line with the safety data of other single-target immuno-checkpoint inhibitors previously reported. KN046 also has shown exciting preliminary clinical results in patients with advanced solid tumors who previously failed immuno-checkpoint inhibitor treatment.


KN026 is an anti-HER2 bispecific antibody developed by Jiangsu Alphamab using the proprietary Fc-based heterodimer bispecific platform technology called CRIB. Currently, KN026’s Phase I dose expansion clinical research has been carried out in China and the United States, with several Phase II clinical trials are ongoing in China, including combo with chemotherapy as HER2-positive metastatic breast cancer first-line treatment, monotherapy for metastatic breast cancer with HER2 low and medium expression which have failed standard treatment, monotherapy as the second-line therapy for late stage gastric cancer with HER2 overexpression or medium-to-low HER2 expression, to further explore the efficacy and safety of KN026 in different patients with advanced solid tumors. The results of Phase I clinical trials show KN026 has encouraging anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.


We will release posters simultaneously on our website on May 29, 8:00 AM – 11:00 AM, EDT. Click here (www.alphamabonc.com)to find out the latest clinical data of KN046 and KN026 published on ASCO.


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.