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Jiangsu Alphamab Reaches Clinical Collaboration with Zelgen to Develop the Combination Therapy of KN046 and Donafenib

Janurary 07, 2020 19:00 Eastern Daylight Time

Suzhou, January 7, 2020 – Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab” or “the Company”), a wholly-owned subsidiary of Alphamab Oncology (stock code: 9966.HK), today announced that it has reached an agreement with Suzhou Zelgen Biopharmaceuticals Co., Ltd. (“Zelgen”, with its IPO registration document approved by the science and technology innovation board,stock code: 688266) for the clinical development of a 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 malignant tumors such as advanced hepatocellular carcinoma.


KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Currently, it is the only anti-PD-L1/CTLA-4 bispecific antibody drug in clinical development phase, and clinical trials have shown good safety and preliminary efficacy. PD-(L)1 and CTLA-4 are two clinically validated immune checkpoints. The efficacy of the combination therapy of PD-(L)1 and CTLA-4 has been verified in clinical trials of multiple tumor types.


Donafenib can not only inhibit the activity of multiple receptor tyrosine kinases, but also directly inhibit various signaling pathways. Therefore, it can inhibit tumor cell proliferation and tumor vessel formation, and improve the tumor microenvironment, thus exerting dual inhibition and blocking multiple targets. Donafenib is the first innovative anticancer drug that has shown a significant increase in overall survival and good safety in a large-scale phase III confirmatory clinical trial of head-to-head control with Sorafenib for the first-line treatment of advanced hepatocellular carcinoma in the past 12 years.


Based on the extensive anticancer spectrum of KN046 and Donafenib, the clinical development of this combination therapy may bring significant benefits to patients with advanced cancer.


Dr. Ting Xu, Founder, Chairman and CEO of Jiangsu Alphamab, said, "Jiangsu Alphamab is a leading clinical stage biopharmaceutical company in China. KN046 is an important program under development in our bispecific antibody product pipeline. It may have huge potential in multiple indications.  As a key part of KN046 clinical development,we are very happy to collaborate with Zelgen and look forward to exploring the potential efficacy of KN046 and Donafenib combination therapy, which may offer better treatment options for cancer patients."


Dr. Zelin Sheng, Chairman and General Manager of Zelgen, commented, “Donafenib is a new molecularly targeted drug that has shown clear efficacy in a variety of malignancies such as advanced hepatocellular carcinoma. We are very pleased to work with Jiangsu Alphamab, an innovative company developing dual-targeting immuno-oncology antibodies, to collaborate on clinical innovation and jointly develop treatment options that can benefit more cancer patients. We believe that the combination of Donafenib and KN046 will provide potential treatment for cancer patients in improving their survival benefits and quality of life."


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 bispecific antibody fused with PD-L1 antibody; engineered to target the tumor microenvironment with high PD-L1 expression; a proprietary CTLA-4 domain antibody with a significantly improved safety profile; Treg clearing function. The preclinical and clinical study results of KN046 have shown promising efficacy and 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 an initial profile of good safety and promising efficacy, and several phase II clinical trials are ongoing in China for NSCLC, TNBC and ESCC.


About Donafenib


Donafenib is an innovative small-molecule drug independently developed by Zelgen. It is a multi-target kinase (VEGFR, PDGFR, Raf/MEK/ERK, etc.) inhibitor. Donafenib has good therapeutic activities  on a variety of malignancies. It has fully met the pre-set primary study endpoints and statistical requirements in the phase III registration clinical study of first-line treatment of advanced hepatocellular carcinoma, with much improved overall survival benefits in patients treated with Donafenib,, compared to that of existing standard treatment Sorafenib, which has important scientific significance and clinical value;  Donafenib also has better safety and is well tolerated by patients.


Donafenib is in clinical trials for multiple indications, and more than 1,000 patients with advanced malignancies have been treated with Donafenib. Currently, in addition to the first-line treatment of advanced hepatocellular carcinoma, many other clinical trials are ongoing for Donafenib, including a phase III clinical trial of third-line treatment for advanced colorectal cancer, a phase III clinical trial for locally advanced / metastatic radioactive iodine refractory differentiated thyroid cancer, a phase Ib clinical trial for advanced nasopharyngeal cancer and a phase I clinical trial for acute myeloid leukemia.


About Alphamab Oncology (Stock code: 9966.HK)


Alphamab Oncology is a leading clinical-stage biopharmaceutical company in China with fully integrated proprietary biologics platform 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 clinical development phase. With multiple in-house proprietary platforms for innovative biopharmaceuticals, Alphamab Oncology has built a robust pipeline in oncology / immunology to benefit cancer patients around the world.

Visit http://www.alphamabonc.com for more information.


About Zelgen (Stock code: 688266)


Zelgen is an innovation-driven new drug research and development company focusing on multiple therapeutic areas such as oncology, blood disorders, and liver and gallbladder diseases.  Its listing registration document have been approved by the science and technology innovation board. Zelgen has three research and development centers separately in Shanghai Zhangjiang, Jiangsu Kunshan, and California. The company has successfully established two core technology platforms, i.e. small-molecule drug precision development and industrialization platform, and complex recombinant protein new drug development and industrialization platform. Currently, Zelgen has 11 innovative drugs in its pipeline, six of which have advanced into clinical development phase.

Visit www.zelgen.com for more information.