august 16, 2020 - alphamab oncology (stock code: 9966 hk) announced that jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab”), a wholly-owned subsidiary of the company, hosted “a multi-center phase iii clinical trials to evaluate efficacy and safety of combination therapy of kn046 and platinum-based chemotherapy versus a combination therapy of placebo and platinum-based chemotherapy in patients with stage iv squamous non-small cell lung cancer" (study no.: kn046-301) researcher conference in shanghai, representing the official start of phase iii clinical trial for bispecific antibody kn046. researchers from more than 40 clinical trial centers across the country have attended the conference online and onsite, together with alphamab oncology teams and collaborators’ teams.
kn046 is the world's first recombinant humanized pd-l1/ctla-4 bispecific invented by alphamab oncology and obtained ind approval in 2018. kn046 entered phase i clinical trials in australia and china concurrently, and directly entered phase ii clinical trial in the united states in 2020. currently, there are about 20 clinical trials in different stages covering more than 10 types of tumors including nsclc, tnbc, escc and pancreatic cancer. the results of these clinical trials have shown a preliminary profile of good safety and promising efficacy.
the phase ii clinical study of combination therapy of kn046 and chemotherapy to treat non-small cell lung cancer patients was launched in august 2019. as of march 2020, clinical efficacy observations of 53 test patients have been completed and generated corresponding safety and efficacy data. the kn046-301 study launched this time is a randomized, double-blind, placebo-controlled trial, with professor zhou caicun from shanghai pulmonary hospital as the main research investigator. it will be carried out in about 60 research centers, with a plan to recruit about 500 volunteers to evaluate the safety and efficacy of combination therapy of kn046 with dosing of 5mg/kg and chemotherapy. the primary endpoint is the progression-free survival determined by irc according to the recist 1.1 standard.
professor zhou caicun, director of oncology department from shanghai pulmonary hospital commented, “immunotherapy is very important for the treatment of malignant tumors. we are very pleased to see that alphamab oncology has been consistently focusing on the unmet tumor treatment needs and has developed a variety of innovative drugs with significant potential. the prior clinical trial of kn046 has achieved encouraging results. we hope that in the upcoming phase iii clinical trial, researchers from all clinical trial centers across the country will work together to contribute to the research and development of innovative medicine for lung cancer treatment and benefit more patients.”
dr. ting xu, founder, chairman and ceo of alphamab oncology commented, “kn046 is the world's first recombinant humanized pd-l1/ctla-4 bispecific invented by alphamab. we are actively deploying comprehensive kn046 combination therapy development strategy to enter new clinical stage quickly. this phase iii clinical trial is for kn046's bla registration in china. kn046 will be the second of our pipeline of to enter the bla registration trial stage after kn035 entered the bla registration trial stage as the world's first subcutaneous injectable pd-l1 antibody, demonstrating alphamab oncology’s commitment to develop first-class biological therapies and benefit more patients.”
ms. yang liu, executive director and vice president of corporate operations of alphamab oncology commented, “thanks to many research institutions and research experts, we are very pleased to see the innovative immunotherapy drug candidate kn046 has delivered good safety and efficacy data. the phase iii researcher conference today is a new milestone, it marks that alphamab oncology has taken a step forward to introduce the bispecific antibody kn046 to the market and provide patients with an additional treatment option. the company's clinical, manufacturing, quality, supply chain, registration and other teams will work together seamlessly to ensure that the launch of kn046 as early as possible to serve more patients. we believe that with our joint efforts, we will develop more innovative biological drugs to contribute to enable tumors to become controllable and curable diseases.”
during the conference, alphamab oncology’s vice president of clinical operation paul kong, dr. junfang xu, dr. jiazhu fang, professor shengjian zhang from the department of radiology, oncology hospital affiliated with fudan university, and dr. wei li from shanghai pulmonary hospital elaborated on the discovery research data of kn046, the clinical research results, the clinical trial plan, irae and other related contents. moreover, experts conducted in-depth discussion on clinical trials related topics and provided valuable suggestions, laying a solid foundation to ensure that this clinical trial will be conducted according to ethically and scientifically sound principles.
about kn046
kn046 is the world's first recombinant humanized pd-l1/ctla-4 bispecific invented by alphamab. its innovative designs include: a proprietary ctla-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with pd-l1 antibody; engineered to target the tumor microenvironment with high pd-l1 expression, and treg clearing function. the preclinical and clinical study results of kn046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become the breakthrough immuno-oncology therapy.
previously, kn046's phase i clinical trials in australia and china have shown a preliminary profile of good safety and promising efficacy, and several phase ii clinical trials are ongoing in china for nsclc, tnbc, escc and pancreatic cancer. us fda has approved kn046 to enter phase ii trial based on the clinical results in china and australia.
about alphamab oncology
alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine in 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.
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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.
