on april 17, 2021, alphamab oncology hosted a mid-term investigator' s meeting in hangzhou about “multi-center phase iii clinical study of efficacy and safety of kn046 in combination with platinum-containing chemotherapy compared with placebo combined with platinum-containing chemotherapy in patients with advanced squamous non-small cell lung cancer” (research number: enreach-lung-01). more than 70 researchers including professor caicun zhou, director of the department of oncology from shanghai pulmonary hospital affiliated to tongji university and professor nong xu, director of oncology department of the first affiliated hospital, zhejiang university school of medicine were invited to attend. researchers from many clinical trial centers across the country participated online to share the progress of the project. dr. ting xu, chairman and ceo of alphamab oncology, and dr. johannes nippgen, chief medical officer, and enreach-lung-01 team members attended the meeting as well.
enreach-lung-01 is a multi-center, randomized, double-blind, placebo-controlled phase iii clinical study of kn046 in combination of platinum-containing chemotherapy in patients with advanced unresectable or metastatic squamous non-small cell lung cancer. professor caicun zhou from the shanghai pulmonary hospital affiliated to tongji university is the principal investigator. the study is conducted in more than 60 clinical research centers nationwide. it plans to recruit about 500 patients to evaluate the safety and efficacy of kn046 plus chemotherapy as the new combination option for front line nsclc treatment.
at the meeting, professor caicun zhou, director of the department of oncology from shanghai pulmonary hospital affiliated to tongji university, gave an opening speech. from the perspective of academic research in the field of global lung cancer treatment, he highly praised the enreach-lung-01 trial and placed high expectations. professor caicun zhou commented, “immunotherapy is an important research progress in the field of lung cancer. numerous international studies have shown the obvious clinical benefit to patients, but the overall prognosis and long-term efficacy of patients still need to be improved. alphamab oncology is a leader among chinese pharmaceutical companies for developing novel oncology therapies. the enreach-lung-01 trial is the world’s first phase iii clinical trial for kn046, a bispecific antibody independently developed by the company, which has the potential to evolve new treatment option for lung cancer. we look forward to the joint efforts of all researchers to complete this study as soon as possible. promote the cutting-edge, high-quality immunotherapy drugs originally developed from china to the world, and contribute to the global lung cancer treatment."
dr. ting xu, chairman and ceo of alphamab oncology, delivered a welcome speech and gave an outline of alphamab oncology 's research and development in the field of novel biologics for cancer patients. dr. ting xu commented, “alphamab oncology always focuses on the development, production and commercialization of innovative anti-tumor drugs, and focuses on unmet medical needs. kn046 has a unique anti-tumor mechanism and has shown impressive patient survival benefits in clinical projects for multiple tumor types such as lung cancer, thymic cancer, and triple-negative breast cancer. the enreach-lung-01 trial is the first phase iii clinical trial for the bispecific antibody in the world. it will collect solid clinical evidence to bring new therapies for global cancer treatment. we look forward to the early completion of the trial with the joint efforts from our investigators; we appreciate the efforts of our patients and wish this trial bring significant survival benefit and well-being to them."
dr. johannes nippgen, chief medical officer of alphamab oncology, focused on the development strategy and clinical development plan of clinical stage new assets. dr. johannes nippgen commented, “kn046 has shown favorable safety and efficacy in clinical studies involving about 600 patients with multiple tumor types from early-stage clinical studies. we are looking forward to the world’s first large-scale phase iii clinical study of the pd-l1/ ctla-4 bispecific antibody. we hope that this study will not only provide new treatment options for lung cancer patients worldwide, but also provide new ideas and directions for us to continue to leverage the company's technology platform to develop new drugs.”
the meeting was hosted by professor caicun zhou, director of the department of oncology from shanghai pulmonary hospital affiliated to tongji university, and professor nong xu, director of oncology department of the first affiliated hospital, zhejiang university school of medicine. professor anwen xiong of shanghai pulmonary hospital and professor xingya li of the first affiliated hospital of zhengzhou university respectively shared enreach -lung-01 clinical research experience and non-small cell lung cancer research progress. at present, this multi-center phase iii clinical research has been launched in more than 50 research centers, and enrollment is progressing smoothly. it is expected that all about 60 research centers across the country will be launched in may, and the first interim analysis data expected to be seen by the end of this year.
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, tnbc, escc, hcc and pancreatic cancer 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. two 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 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 multifunctional 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 an 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.
