latest progress! another ind approval for combination therapy of alphamab’s bispecific antibody kn046-凯发vip

english 中文简体 中文繁体

latest progress! another ind approval for combination therapy of alphamab’s bispecific antibody kn046

august 20, 2020 16:43 eastern daylight time

suzhou, china, august 17, 2020 - alphamab oncology (stock code: 9966 hk) announced today that jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab”), a wholly-owned subsidiary of the company, has received approval for an ind application from national medical products administration (nmpa) of china for combination therapy of kn046, a recombinant humanized pd-l1/ctla-4 bispecific antibody, and donafenib tosylate (“donafenib”), a multi-target kinase inhibitor, for the treatment of late stage gastrointestinal tumors.


gastrointestinal tumors account for more than 40% of overall cancer incidence, causing severe disease burden to patients. among gastrointestinal tumors., liver cancer has new incident of 841,000 globally, representing no.6 in malignant tumors, and 782,000 deaths, representing no.2 in malignant tumors. primary liver cancer is particularly prevalent in china, being the fourth most common malignant tumor and the second leading cause of death by tumor. liver cancer has annual new incident of 466,000 and causes 422,000 death. the overall prognosis of liver cancer patients in china is poor with 5-year survival rate of only 12.1%. and the 5-year survival rate of patients with late stage liver cancer is less than 5%. in recent years, immunotherapy has become an important treatment for liver cancer, but pd-(l)1 and ctla-4 inhibitors have low response rate for patients with gastrointestinal tumors. alphamab is focusing on combination therapy of immunotherapy and other medicine to improve the efficacy in liver cancer and other gastrointestinal tumors.


on january 7, 2020, jiangsu alphamab and suzhou zelgen biopharmaceuticals co., ltd. (“zelgen”) reached an collaboration agreement for the clinical development of a combination therapy of kn046 and donafenib, focusing on the treatment of late stage hepatocellular carcinoma (“hcc”) with a plan to potentially expand to other gastrointestinal tumors


kn046 is an immune checkpoint bispecific antibody independently developed by alphamab, targeting two important validated immuno-modulating targets pd-l1 and ctla-4 simultaneously,  potentially reducing the inhibition of tumor-specific lymphocytes at two different aspects of immune regulation, thereby potentially activating t cells more effectively and enhancing immune anti-tumor capability. currently, there are about 20 clinical trials of kn046 in different stages covering more than 10 types of tumors including nsclc, tnbc, escc and pancreatic cancer. the results of multiple mono-therapy clinical trials have shown a preliminary profile of good safety and promising efficacy. alphamab oncology is actively deploying multiple combination therapy development strategies to unlock the significant potential of kn046. previously,  both the ind of combination therapy of kn046 and kn026 to treat her2-positive or her2 expression solid tumors,  and the ind application of the combination therapy of kn046 and ct053 to treat hematological tumors and solid tumors has received approval from national medical products administration (nmpa) of china in may 2020. the phase iii clinical trials to evaluate efficacy and safety of combination therapy of kn046 and platinum-based chemotherapy in patients with stage iv squamous non-small cell lung cancer have started in china.


donafenib tosylate is a multi-target kinase inhibitor developed by zelgen. it can not only inhibit multiple tyrosine kinase receptor, but also directly inhibit various signaling pathways  and inhibit tumor cell proliferation and tumor vessel formation to improve the tumor microenvironment. donafenib’s phase iii trial for late stage liver cancer has been completed and nda application has been submitted.


based on the excellent efficacy data of kn046 and donafenib, as well as the extensive and complimentary anti-tumor mechanism of action, the combination therapy of kn046 and donafenib could potentially create significant synergy. the first phase i/ii clinical trial of the combination therapy will adopt a single/multicenter, open, dose-escalation and dose-expansion design to evaluate the safety, tolerability and anti-tumor efficacy of combination of kn046 infusion and donafenib tosylate tablet in patients with late stage hepatocellular carcinoma or other late stage gastrointestinal tumor. this combination therapy could provide a better treatment option to treat late stage gastrointestinal tumor such as hepatocellular carcinoma.


about kn046

kn046 is the world's first recombinant humanized pd-l1/ctla-4 bispecific invented by 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 breakthrough immuno-oncology therapy.


currently, there are about 20 clinical trials of kn046 in different stages covering more than 10 types of tumors including nsclc, tnbc, escc and pancreatic cancer in australia and china. the results of these clinical trials have shown a preliminary profile of good safety and promising efficacy. kn046 has directly entered phase ii clinical trial in the united states in 2020 based on the result in australia and china. the phase iii clinical trials to evaluate efficacy and safety of combination therapy of kn046 and platinum-based chemotherapy in patients with stage iv squamous non-small cell lung cancer have started in china


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.


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.