suzhou, china, march 31, 2022 - alphamab oncology (stock code: 9966.hk), announced that the first phase iii clinical study of its proprietary pd-l1/ctla-4 bispecific antibody kn046 (enreach-lung-01), has successfully completed the first interim analysis and met its prespecified endpoint of improving progression-free survival (pfs).
enreach-lung-01 is a multicenter, 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 to evaluate the safety and efficacy over standard treatments. the trial is led by professor caicun zhou from shanghai pulmonary hospital. 482 patients were enrolled in 61 clinical research centers nationwide.
according to the first interim analysis conducted by an independent data monitoring committee (idmc) on enreach-lung-01, based on the assessment of the blinded independent review committee (birc), kn046 significantly extended the progression-free survival (pfs) of the intention-to-treat (itt) patients. the pfs benefit reached the prespecified target. the safety profile is consistent with the relevant clinical research results of kn046 that we reported before. no new safety signal was observed. this interim analysis does not include os analysis, and we expect to obtain the os data as the trial ongoing. detailed clinical results of enreach-lung-01 are expected to be published at international academic conferences in the future. based on this result, the nda is going to be filed as scheduled.
key milestones in the enreach-lung-01 study
in august 2020, the enreach-lung-01 study was initiated.
in september 2020, first patient was dosed.
in october 2021, the enrollment of 482 patients completed ahead of schedule.
in march 2022, the first interim analysis for pfs reached prespecified target.
about kn046
kn046 is pd-l1/ctla-4 bispecific antibody independently developed by jiangsu alphamab. its innovative designs include: a novel 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, the us and china. the results of these clinical trials have shown an advantage in survival for patients. alphamab oncology 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, including discovery, development, 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 a fully integrated proprietary biologics platforms in bi-specifics and protein engineering. its highly differentiated in-house pipeline consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. five products have advanced into phase i-iii clinical trials in china, the united states, japan and australia and in november 2021, one of these products, the unique pd-l1 antibody for subcutaneous administration, 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.
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.
