major progress in her2 bispecific antibody! alphamab oncology kn026 liquid formulation was approved for clinical use-凯发88

english 中文简体 中文繁体

major progress in her2 bispecific antibody! alphamab oncology kn026 liquid formulation was approved for clinical use

august 17, 2021 08:47 eastern daylight time

suzhou, china, august 17, 2021 - alphamab oncology (stock code:9966.hk), announced that recently, the company received the "notice of approval of supplementary application for drug clinical trials" from the national medical products administration (nmpa), which approved the supplementary application for the pharmaceutical change of kn026, a recombinant humanized anti-her2 bispecific antibody, to use a liquid formulation for clinical research. this is the world's first her2 bispecific antibody approved for clinical research in liquid formulations.

 

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). it can bind two non-overlapping epitopes of her2 simultaneously, leading to a dual her2 signal blockade. in pre-clinical studies, kn026 has demonstrated equivalent efficacy compared with the combinaton of trastuzumab and pertuzumab and was superior to either single agent in her2-positive tumor cell lines. in terms of production, the molecular size and shape of kn026 are the same as those of native igg antibodies. under current antibody production process, the product yield and quality have reached the world's leading level.

 

kn026 received ind approval from the national medical products administration (nmpa) of china and u.s. food and drug administration (fda) in 2018, and several phase i/ii clinical studies are undergoing, including her2 low expression or positive breast cancer, advanced her2 positive gastric and gastroesophageal junction cancer, her2-positive solid tumors, etc., showing good safety and significant anti-tumor activity.

 

dr. ting xu, chairman and ceo of alphamab oncology, commented, “kn026 has a unique competitive advantage among global her2 targeted agents. the approval of this liquid formulation for clinical research will provide more convenience to patients and medical staff for administration,and lay a good foundation for the development of subcutaneous injection administration in the future. this is in line with our mission to make cancer manageable and curable. we will continue to improve the quality of life of patients through innovation.”

 

about kn026

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. kn026 has demonstrated potentially equivalent efficacy compared with trastuzumab and pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor 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 received ind approval from the national medical products administration (nmpa) of china and u.s. food and drug administration (fda) in 2018. currently, it is in multiple phase i/ii clinical trials in china and phase i clinical trial in the united states. the results of phase i clinical trials show kn026 has good safety, tolerance and potentially superior anti-tumor activity in her2-positive breast cancer patients who progressed after multiple lines of anti-her2 treatment.

 

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.