suzhou, november 23, 2021 - alphamab oncology (stock code: 9966.hk) and cspc pharmaceutical group co., ltd. (stock code: 1093.hk) jointly announced that data from a phase ii clinical study（kn026-203）of kn046 in combination with kn026 in patients with metastatic her2-positive breast cancer will be presented as a poster at the 44th san antonio breast cancer symposium (sabcs 2021) from 7-10 december 2021.
sabcs is the world's largest, highest-level and most influential international academic conference in the field of breast cancer. since 1977, it has developed into a seminar attended by researchers and doctors from more than 90 countries around the world. sabcs aims to provide international academia, physicians and researchers with cutting-edge information on experimental biology, etiology, prevention, diagnosis and treatment of breast cancer and precancerous breast diseases.
poster title: preliminary safety and efficacy results of kn046 (an anti-pd-l1/ctla-4 bispecific antibody) in combination with kn026 (a her2-targeted bispecific antibody) in patients with metastatic her2-positive breast cancer: a phase ii trial
first author: professor jieqiong liu, guangdong provincial key laboratory of malignant tumor epigenetics and gene regulation, breast tumor center, sun yat-sen memorial hospital, sun yat-sen university, guangzhou, guangdong, china
professor chuangui song，department of breast surgery, fujian medical university union hospital, fuzhou, fujian, china
breast cancer is the most common cause of cancer death for women worldwide. according to the latest global cancer burden data released by the world health organization's international agency for research on cancer (iarc) in 2020, the number of new breast cancer cases worldwide has increased to 2.26 million in 2020, surpassing the number of new lung cancer cases (2.21 million) for the first time, becoming the world's number one cancer. although significant achievement has been made in early detection of breast cancer, metastasis is found in up to 5% of the female patients with breast cancer at diagnosis. her2-targeted therapies combined with chemotherapy have improved the survival outcomes of patients with metastatic her2-positive breast cancer. however, some patients progressed after several lines of anti-her2 combinational therapies, and their overall survival (os) needs to be improved with effective therapies.
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 kn046
kn046 is pd-l1/ctla-4 bispecific antibody independently developed by jiangsu alphamab. its innovative designs include: a different mechanism ctla-4 fused with pd-l1 single domain antibody; engineered to target the tumor microenvironment with high pd-l1 expression, and treg（suppress tumor immunity） clearing function.
there are about 20 clinical trials of kn046 in different stages covering more than 10 types of tumors including nsclc, thymic cancer, pancreatic cancer, hcc, escc and tnbc in australia and china. the results of these clinical trials have shown an advantage in survival for patients. alphamab has received fda clearance to enter phase ⅱ trial of kn046 based on the clinical results in china and australia. moreover, kn046 has obtained the u.s. fda's orphan drug designation for thymic epithelial tumor in september 2020. four pivotal clinical trials are currently being conducted.
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 oncology 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.
about cspc
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.
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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.
