suzhou, november 24 2021 - alphamab oncology (stock code: 9966.hk) announced that the ind application for phase 3 registration study (kn046-303) of the pd-l1/ctla-4 bispecific antibody kn046 plus nab-paclitaxel/gemcitabine for the treatment of advanced pancreatic ductal adenocarcinoma (pdac) was approved by the center for drug evaluation (cde) of the nmpa.
kn046-303 is a randomized, double-blind, multicenter phase iii study in patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (pdac) who have not previously received systemic treatment. 408 patients will be randomized 1:1 and receive kn046 (or placebo) plus nab-paclitaxel/gemcitabine. the primary endpoints are progression-free survival (pfs) assessed by independent review committee (irc) and overall survival (os). key secondary endpoint is the objective response rate (orr) assessed by irc.
pancreatic cancer is one of the common malignant tumors in digestive tract with a high fatality rate. pancreatic ductal adenocarcinoma (pdac) originates in the exocrine tissue and is the most common type of pancreatic cancer (about 90%), which is difficult to diagnose, progresses quickly with poor prognosis. globocan 2020 estimates that pancreatic cancer caused about 466,000 deaths and 496,000 new cases each year. there were an estimated 125,000 new cases and 122,000 deaths as a result of pancreatic cancer in china in 2020. compared with 2015 data, the incidence rates increased by about 32%, showing a strong upward trend, with annual deaths almost equal to new cases. the 5-year survival rate for pancreatic cancer is only 9% globally, and only 3% to 5% in china. improving diagnosis and treatment of pancreatic cancer and the prognosis of patients are urgent unmet clinical needs to be addressed.
the current standard of care treatment for advanced pdac is combination chemotherapy, e.g., the combination of nab-paclitaxel and gemcitabine. however the orr is only about 25%, and patients progress quickly, still indicating urgent unmet medical needs.
kn046 is a pd-l1/ ctla-4 bispecific antibody independently developed by alphamab oncology. in an investigator-initiated phase ii clinical study, kn046 plus nab-paclitaxel and gemcitabine in the first-line treatment of pdac more than doubled the objective response rate (orr) vs the ag regimen. primary results from this study were first presented in a poster session at the asco 2021. the updated results from this clinical study with more patients included in the efficacy analysis were presented at 24th annual meeting of csco.
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 registrational 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.
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.
