suzhou, january 4, 2022- alphamab oncology (stock code: 9966.hk) and cspc pharmaceutical group co., ltd. (stock code: 1093.hk) jointly announced that the ind application for the pivotal clinical trial (kn026-csp-001) of the anti-her2 bispecific antibody kn026 combined with chemotherapy was approved by the center for drug evaluation (cde) of nmpa.
kn026-csp-001 is a randomized, multi-center, phase ii/iii clinical study to evaluate the efficacy and safety of kn026 combined with chemotherapy in patients with her2-positive gastric cancer (including gastroesophageal junction cancer) who have failed first-line treatment, with professor jianming xu from the chinese people's liberation army general hospital as principal investigator.
gc/gej is one of the common malignant tumors and there are more than 1 million new cases each year in the world. the incidence of gastric cancer is high in china, with about 410,000 new cases and 294,000 deaths each year, accounting for more than 40% of both new and death cases of gc/gej worldwide. gastric cancer in china is characterized by low diagnosis rate of early gastric cancer, high proportion of metastatic stage (>80%) and low 5-year survival rate (about 35.1%), which seriously threatens the life and health of people. her2 is overexpressed in many tumors, including about 15-20% in gastric cancer. her2 overexpression is related to tumor aggressiveness and poor prognosis. with the development of targeted therapies, her2-positive advanced gastric cancer patients have achieved better efficacy compared to traditional chemotherapy when treated with a combination of targeted drugs. however, for patients with her2-positive gastric cancer who have progressed or recurred after first-line treatment, there is no effective drug approved in china, and there is a huge unmet clinical need.
kn026 is a her2 bispecific antibody developed by alphamab oncology. data from the phase ii clinical study of kn026, published at asco in 2021, demonstrated favorable safety and promising efficacy in chinese her2 overexpressing gc/gej patients, pretreated either with or without anti her2 treatments. in patients with high expression, the orr was 55.6% and the dcr was 72.2%, and the 9-month pfs rate was 60.4%. among patients receiving prior-her2 treatment, the orr was 44.4%, and the dcr was 66.7%. the approval of the clinical trial application is a touchstone for the cooperation between alphamab oncology and cspc to accelerate the clinical development and commercialization of kn026 in mainland china. we hope to see more positive data from the study, and bring hope to patients with advanced gastric cancer who are in urgent need of new treatment options.
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.
in august 2021, the company entered an agreement with jmt-bio, a wholly-owned subsidiary of cspc pharmaceutical group co., ltd. (stock code: 1093.hk), for the development and commercialization of kn026 in mainland china. according to the terms of the agreement, jmt-bio will obtain the exclusive license rights of kn026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (gc/gej) in mainland china (excluding hong kong, macau and taiwan).
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. in november 2021, envafolimab received marketing authorization from the chinese national medical products administration (nmpa) for the treatment of previously treated msi-h/dmmr advanced solid tumors.
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.
about cpsc
cpsc, listed on the hong kong stock exchange (stock code: 1093), was selected as a constituent stock of the hang sang index in 2018 and was the first constituent stock in the pharmaceutical sector since the launch of the index. currently, it is one of constituent stocks of hang seng composite index, hang seng healthcare index, hang seng mainland healthcare index, hang seng stock connect index, hang seng (hong kong-listed) 100 index and hang seng china enterprise index. as of the date of this announcement, cpsc has total assets of more than rmb30billion and more than 23,000 employees. cspc has a national top research and development team with research and development bases in shijiazhuang, shanghai, beijing and the united states, focusing on the discovery, research and development of small molecule targeted drugs, nanodrugs, monoclonal antibody drugs, bispecific antibody drugs, antibody-drug conjugates，mrna vaccines, small nucleic acid drugs and biological drugs in the immune field.
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.
