● enreach-lung-01 is a multi-center, randomized, double-blind, placebo-controlled phase iii clinical study of kn046 combined with platinum-containing chemotherapy in patients with advanced unresectable or metastatic squamous nsclc. enrollment of all 482 patients has been completed according to the study design in 61 clinical research centers nationwide.
suzhou, china, october 18, 2021 - alphamab oncology (stock code: 9966.hk), announced that the first phase iii pivotal clinical study of pd-l1/ctla-4 bispecific antibody kn046 in china (enreach-lung-01) has successfully completed enrollment of all patients. a first interim analysis is going to be performed in the first quarter of 2022. based on the data, the process of a first bla submission of kn046 for the treatment of squamous nsclc will be discussed with authorities and might be submitted as early as 2022.
enreach-lung-01 is a multicenter, randomized, double-blind, placebo-controlled phase iii clinical study of kn046(5 mg/kg) combined with platinum-containing chemotherapy in patients with advanced unresectable or metastatic squamous nsclc to evaluate the safety and efficacy over standard treatments. 482 patients were enrolled in 61 clinical research centers nationwide.
the principal investigator professor caicun zhou, director of the department of oncology from shanghai pulmonary hospital affiliated to tongji university, commented, " we are very pleased to lead the enreach-lung-01 study, which is the first phase iii clinical study of a bispecific antibody for the treatment of nsclc in china. lung cancer is one of the most common malignant tumors globally and poses a great threat to human health. patients with advanced lung cancer have poor prognosis and there is an urgent need to improve the overall survival. through this clinical study, we hope that the bispecific antibody kn046 could bring long-term survival benefits to patients. we look forward to evolving a new treatment option for lung cancer and bringing significant clinical benefits to more advanced lung cancer patients in need."
dr. ting xu, chairman and ceo of alphamab oncology, commented, “the successful completion of patient enrollment in enreach-lung-01 is an important milestone in the clinical development and commercialization of kn046. we believe that kn046 combined with chemotherapy can bring better treatment options for advanced squamous nsclc patients. we sincerely thank the investigators and patients who participated in this clinical trial. we look forward to seeing data from first interim analysis, and the company is well prepared for the bla of kn046 planned to be submitted in 2022 after discussions with authorities.”
about kn046
kn046 is pd-l1/ctla-4 bispecific antibody independently developed by jiangsu alphamab. its innovative designs include: a novel mechanism ctla-4 domain fused with a 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 promising data in terms of survival for patients. alphamab oncology has received fda clearance to enter later stage trials 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 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.
