suzhou, june 19, 2020 - alphamab oncology (stock code: 9966 hk) announced that jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab” or “alphamab oncology”), a wholly-owned subsidiary of the company, has entered a partnership agreement with sinovent, to jointly develop the combination therapy of pd-l1 / ctla-4 bispecific antibody kn046 and small-molecule inhibitor xnw7201 in oncology indications.
this collaboration will explore the safety, tolerability, and efficacy of the combination therapy of kn046 and xnw7201 for advanced malignant tumors such as pancreatic cancer. pancreatic cancer is one kind of malignant tumors with the worst prognosis and known as the “king of cancer”. globally, there were about 459,000 new cases of pancreatic cancer and 432,000 deaths in 2018. in china, the morbidity and mortality rate of pancreatic cancer among malignant tumors was ranked 10th and 6th respectively, with 95,000 new cases and 85,000 deaths in 2015. pancreatic cancer is extremely malignant, and the 5-year survival rate of advanced pancreatic cancer is less than 5%. there is an urgent need for better treatments to prolong patients’ survival period and improve patient’s quality of life.
kn046 is a recombinant humanized pd-l1/ctla-4 bispecific antibody independently developed by jiangsu alphamab, xnw7201 is a small-molecule porcupine protein inhibitor developed by sinovent by targeting the wnt pathway. based on the mechanism of kn046 and xnw7201, the combination therapy of two drugs is expected to improve the anti-tumor efficacy. according to the agreement, alphamab oncology and sinovent will establish a joint-development committee to jointly finance their cooperation on the pre-clinical development, the application of ind, clinical development and registration for the anti-tumor combination theraoy.
dr. ting xu, founder, chairman and ceo of alphamab oncology commented, “kn046 is a bispecific antibody focusing on pd-l1 and ctla-4 which are the two clinically validated immuno-oncology targets, with the potential to become the breakthrough immuno-oncology therapy. currently there are about 20 kn046 clinical trials covering more than 10 oncology indications globally and have shown good safety and preliminary efficacy in various tumor types. based on the results and experiences from these clinical trials, alphamab oncology will continue to develop various combination therapies for kn046. it has shown preliminary promising efficacy signal for last line pancreatic cancer in a phase i clinical trial. through cooperation with sinovent, we look forward to realizing the synergy from the combination of kn046 and xnw7201, and achieving significant efficacy in the treatment of pancreatic cancer and other advanced malignant tumors with insufficient immune response.”
mr. jing qiang, founder and chairman of sinovent commented, “xnw7201 is a small-molecule inhibitor which can inhibit porcupine, block wnt signaling pathway, and inhibit the proliferation of tumor cells and differentiation of tumor stem cells to achieve anti-tumor effect. wnt pathway is a popular global anti-tumor research target, commonly seen in gastrointestinal tumors. xnw7201’s efficacy has been well studied in various animal vivo experiments and has shown a preliminary promising inhibitory effect on pancreatic cancer, gastric cancer and other gastrointestinal tumors. currently, xnw7201 has started clinical development in china and australia and it is expected to become a global first-in-class drug candidate. moreover, excessive activation of the wnt pathway is an important reason for the poor infiltration of immune cells into tumor tissues. we look forward to the improved the efficiency and efficacy of the immune response from the combination therapy of kn046 and xnw7201.”
about kn046
kn046 is the world's first recombinant humanized pd-l1/ctla-4 bispecific antibody independently developed by jiangsu alphamab. its innovative designs include: a proprietary ctla-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with pd-l1 antibody; engineered to target the tumor microenvironment with high pd-l1 expression, and treg clearing function. the preclinical and clinical study results of kn046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become the backbone of next generation immuno-oncology therapy in the future.
previously, kn046's phase i clinical trials in australia and china have shown a preliminary profile of good safety and promising efficacy, and several phase ii clinical trials are ongoing in china for nsclc, tnbc, escc and pancreatic cancer.
about xnw7201
xnw7201 is a small-molecule inhibitor developed by sinovent that targets the wnt pathway porcupine protein which plays the critical role of blocking or stagnating in the wnt pathway. inhibiting porcupine protein can block abnormally activated wnt signaling pathway to inhibit the proliferation of tumor cells and differentiation of tumor stem cells to achieve anti-tumor effect. wnt mutation is highly expressed in gastrointestinal tumors and becomes a popular global anti-tumor research target. however, due to r&d difficulty, there are only a few companies including sionvent globally which are at the clinical stage. extensive research has indicated that excessive activation of the wnt pathway may be associated with tumor immuno-escaping. also, the activated wnt pathway in tumor may cause the poor infiltration of immune cells into tumor tissues so the wnt pathway inhibitor is expected to enhance the efficacy of immune-oncology therapy.
xnw7201 has excellent selectivity and pk characteristics, the pre-clinical efficacy has been verified in various animal vivo studies, and has shown a significant inhibitory effect on gastric cancer, colorectal cancer, pancreatic cancer and esophageal cancer. currently, xnw7201 has started phase i clinical trials in china and australia and has shown good safety and preliminary efficacy.
about alphamab oncology
alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine in 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 consists of eight anti-cancer drug candidates, four of which have advanced into phase i – iii clinical development phases in china, us and japan.
the company also has state-of-the-art manufacturing capability designed and built to meet nmpa and eu/fda’s cgmp standards. alphamab oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world.
visit http://www.alphamabonc.com for more information.
about sinovent
founded in 2016, sinovent is an innovative pharmaceutical company focusing on small molecules to address significant unmet clinical needs with global intellectual property rights.
headquartered in suzhou, sinovent has offices in beijing, shanghai, australia and boston, with a complete global r&d and manufacturing system. the team includes top talents in scientific research, clinical development, manufacturing and sales in the industry. it has won many important awards such as suzhou unicorn cultivation enterprise, jiangsu province entrepreneurship and innovation plan, and leading talents of suzhou.
the company has 2 strategic focus on the next generation candidates on mature targets as well as first-in-class products focusing on new targets. there are 4 drug candidates that have entered the clinical stage in china and abroad. 4 other drug candidates are currently in the ind enabling stage, covering oncology and antibiotics areas.
visit http://www.sinovent.com.cn for more information.
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.
