alphamab received u.s. fda ind clearance to initiate a phase ii pivotal clinical trial of kn046 (kn046-凯发vip

english 中文简体 中文繁体

alphamab received u.s. fda ind clearance to initiate a phase ii pivotal clinical trial of kn046 (kn046-205, enreach-thymic) in the u.s.

march 09, 2021 08:00 eastern daylight time

suzhou, march 9, 2021 - alphamab oncology (stock code: 9966.hk) announced that u.s. food and drug administration (fda) has cleared the company's investigational new drug application (ind) to initiate an open label, multi-center phase ii pivotal clinical study (clinical trial no.: kn046-205) in the united states to evaluate the efficacy, safety and tolerability of kn046 (pd-l1/ctla-4 bispecific antibody) for the treatment of thymic carcinoma.


thymic carcinoma is a rare but highly aggressive thymic tumor, and the most aggressive subtype of thymic epithelial tumors, accounting for about 20%. the number of patients with thymic carcinoma is about 4,200 to 6,000 in china per year, and 1,400 to 2,000 in the united states per year. inoperable or metastatic thymic carcinoma has a very poor prognosis, and there is currently no approved standard treatment for patients who have failed platinum-based chemotherapy. the median overall survival after late-line chemotherapy or targeted therapy is less than 12 months, and there is an urgent need for better options to improve the efficacy.


kn046 is a bispecific antibody targeting pd-l1 and ctla-4 immune checkpoints. it can more effectively activate t-cells and enhance the t-cells cancer killing ability. in a phase i clinical study conducted in australia, kn046 showed a 75% disease response rate and 100% disease control rate in patients with thymic epithelial tumors. the research data was presented at the 21st world conference on lung cancer (wclc 2020). in september 2020, kn046 was granted the orphan drug designation by the fda for the treatment of thymic epithelial tumors. in january 2021, the phase ii pivotal clinical trial of kn046 for the treatment of thymic carcinoma (clinical trial no.: enreach-thymic) completed enrollment of the first patient in china.


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 a biopharmaceutical company focusing on innovative biologics medicine for 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 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.