first patient dosed in phase i/ii clinical study of pd-凯发88

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first patient dosed in phase i/ii clinical study of pd-l1/ctla-4 bispecific antibody kn046 in combination with donafenib for the treatment of advanced & metastatic hepatocellular carcinoma(hcc)

february 08, 2021 08:00 eastern daylight time

recently, alphamab oncology (stock code: announced that first patient was dosed with key product kn046 (pd-l1/ctla-4 bispecific antibody) in combination with zelgen’s donafenib (vegfr multi-target kinase inhibitors) in phase i/ii clinical study (clinical trial no.: kn046d- c-101) for the treatment of advanced or metastatic hepatocellular carcinoma (hcc).

liver cancer is one of the most common malignant tumors and leading cause of death around the world. it is the second most fatal tumor in china, which accounts for about 50% of new cases and deaths worldwide. about 90% of liver cancers is hepatocellular carcinoma (hcc), and most of the patients are locally advanced or metastatic when they are diagnosed. only 20% can be treated by surgery, and the recurrence or metastasis rate is high. it is urgent to explore more effective systemic treatments, including combination therapies, to further improve the efficacy and survival.

the clinical study of kn046 in combination with donafenib for the treatment of liver cancer (kn046d-c-101) is a multi-center, open label, dose escalation and dose expansion trial, based on the synergistic anti-tumor mechanism of the two drugs, aiming to evaluate the safety, tolerability and efficacy of kn046 in combination with donafenib in patients with advanced & metastatic hepatocellular carcinoma(hcc). the trial is led by professor shukui qin from the hospital of the east china military command of people's liberation army and professor tianshu liu from the zhongshan hospital of fudan university. it is planned to be carried out in about 6 research centers nationwide.

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 registrational 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 fourteen 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.

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