suzhou, china, november 3 2021 - alphamab oncology (stock code: 9966.hk) announced that, the first patient was dosed in china's taiwan region in a clinical trial of pd-l1/ctla-4 bispecific antibody kn046 in combination with alk-1 antibody (gt9001) from kintor pharma (stock code: 9939.hk) for the treatment of advanced or refractory solid tumors.
this study (nct04984668) is a two-phase, multi-center, open-label phase ib/ii clinical trial to evaluate the safety, tolerability, pharmacokinetics (pk) and anti-tumor activity of kn046 in combination with alk-1 antibody in patients with advanced or refractory solid tumors, including hepatocellular carcinoma (hcc), gastric carcinoma/gastroesophageal junction adenocarcinoma (gc/gej), urothelial carcinoma (uc) and esophageal square cell carcinoma (escc).
dr. ting xu, chairman and chief executive officer of alphamab oncology, commented, “kn046 is a bispecific antibody that targets both pd-l1 and ctla-4 immune checkpoints, with a unique anti-tumor mechanism. data from clinical studies of kn046 in pd-(l)1 refractory nsclc, thymic cancer, pancreatic cancer and liver cancer have demonstrated impressive survival benefits. we are also advancing the clinical research of kn046 in combination with other therapies to fully explore its clinical value. we look forward to exploring new mechanisms of tumor immunotherapy through the combination of kn046 with kintor pharma’s alk-1 antibody, and bringing new treatment options for patients.”
dr. youzhi tong, founder, chairman, and chief executive officer of kintor pharma, commented, “we are continuously enriching the pipeline of biological drugs surrounding the alk-1 antibody. the phase ii clinical trial of alk-1 antibody combination therapy on patients with advanced hepatocellular carcinoma (“hcc”) was commenced in taiwan, china, the preliminary data of which showed positive antitumor activity and good safety profile. recently, the clinical trial of alk-1 antibody combination therapy for the first-line treatment of advanced hcc has also been approved by china nmpa. in 2020, we collaborated with alphamab to further explore the clinical strategies of alk-1 antibody in combination with kn046. following the first patient enrolled and dosed in this clinical trial, we hope to accelerate the clinical process and benefit more patients with advanced or refractory solid tumors.”
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 pivotal clinical trials are currently being conducted.
about alk-1 antibody
alk-1 antibody is a fully humanized monoclonal, potential first-in-class antibody that inhibits alk-1/tgf-β signal transduction and tumor angiogenesis.
kintor pharma obtained an exclusive global license for alk-1 antibody from pfizer, inc., in february 2018. the preliminary data of the ongoing taiwan phase ii clinical trial was released at the asco gi 2021 and showed positive efficacy and safety results. the overall response rate (“orr”) was 40 percent.
in february 2021, the u.s. food & drug administration (fda) granted kintor pharma an investigational new drug ("ind") application of alk-1 antibody for a multi-regional phase ii clinical trial for the combination treatment for the second-line treatment of hcc. on 9 october 2021, the clinical trial of combination therapy of alk-1 antibody for the first-line treatment of advanced hcc was approved by the national medical products administration of china.
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 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.
about kintor pharmaceutical limited
kintor pharmaceutical limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including covid-19, prostate, breast and liver cancer, alopecia, and acne.
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.
