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Alphamab Oncology Collaborates with HEC Research Institute on the Combination Therapy of KN046 and CT053

Janurary 25, 2019 17:00 Eastern Daylight Time

Suzhou & Dongguan, January 25, 2019 - Alphamab Oncology and HEC Pharmaceutical Group Research Institute (HEC Research Institute) announced that they will jointly develop the combination therapy of KN046, a PD-L1/CTLA-4 bispecific antibody, and CT053(Ningetinib Toluenesulfonate) for hepatocellular carcinoma (HCC), and advance the treatment to clinical development and commercialization in China.


KN046, a PD-L1/CTLA-4 bispecific antibody developed by Alphamab Oncology, is currently in Phase Ia/Ib clinical trials in China and Australia and will launch several Phase II clinical trials for multiple cancer indications soon. CT053, a novel small molecule drug independently developed by HEC Research Institute, is currently in phase Ib/IIa clinical trials. CT053’s indications include non-small cell lung cancer (NSCLC), which is in Phase IIa clinical trials, and renal cell carcinoma (RCC).  


KN046 is a bispecific antibody designed to target PD-(L)1 and CTLA-4, the only two commercially validated immuno-oncology targets. Alphamab Oncology has screened a new generation CTLA-4 antibody and combined it with a PD-L1 antibody to generate KN046, a dual-target antibody. KN046 has shown preliminary good safety and efficacy in clinical trials. Ningetinib is a multi-target small molecule inhibitor that can effectively inhibit multiple kinase activities such as VEGFR2/AXL/MER/c-Met. It has shown good clinical efficacy and safety in clinical trials in NSCLC, RCC, and AML. This collaboration is based on the synergetic mechanisms of action of the two drug candidates and the clinical safety and preliminary efficacy data observed. KN046 can block PD-L1 and CTLA-4 immune checkpoints in tumor microenvironment; while CT053 has the effect of improving the tumor immune microenvironment, including Treg, MDSC, antigen presentation, natural killer cells and T cell chemotaxis, in addition to its direct tumor suppressing effect. The Combination therapy is expected to generate synergistic anti-tumor effects.


Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, said: "We are very pleased to collaborate with HEC Research Institute on the combination therapy of KN046 and CT053 in liver cancer. The incidence of Liver cancer is quite high in China, where it is mostly caused by HBV infection, and the disease spectrum is very different from that in Europe and the United States. We hope the combination of KN046 and CT053 can demonstrate better efficacy profile. HEC Research Institute has strong strength in small molecule novel drugs, especially in tumor and viral infection field. We hope that this cooperation to advance smoothly and will be the starting point for our further collaboration.


Dr. Yingjun Zhang, president of HEC Research Institute, said: “HEC Group has been actively involved in the research and development of small molecule novel drugs for many years. We are looking forward to collaborating with Alphamab Oncology, a pioneer in biopharmaceutical field. The advantages in combination of multi-kinase inhibitors and immune checkpoint antibody have been verified in many clinical studies globally. Previous studies have shown that the unique activity spectrum of CT053 can produce synergistic anti-tumor effects when combined with immune checkpoint inhibitors, and I believe the combination of CT053 and KN046 could likely achieve good clinical results. Both of our two teams will cooperate effectively and communicate with the regulatory authorities actively to quickly advance the clinical trials of the combination therapy and to obtain efficacy verification in multiple indications, thus benefiting cancer patients in China."


About KN046

KN046 is the world's first PD-L1/CTLA-4 bispecific antibody solely developed by Alphamab Oncology internally. KN046 has shown good safety profile in both preclinical and clinical studies and encouraging preliminary efficacy results in Phase I clinical trials. The novel designs of KN046 makeit well ahead of peer PD-L1/CTLA-4 bispecific globally, with the potential to become the cornerstone of the second generation of immuno-oncology therapy.


About CT053

CT053 (nonproprietary name: Ningetinib Toluenesulfonate) is a multi-target small molecule inhibitor independently developed by HEC Research Institute. The main targets include c-Met, Axl, MER, VEGFR2, etc. With these targets, CT053 can, on the one hand, block MAPK/ERK and PI3K/AKT cancer signaling pathways by inhibiting HGF/c-Met and Gas6/AXL/Mer and directly inhibit tumor growth; on the other hand, block the formation of tumor neovascularization through inhibiting VEGF/VEGFR2 and thus inhibiting the growth of tumor cells indirectly. Ningetinib has shown better clinical results than some of its competing drugs and is expected to become an important drug for cancer treatment.


About Alphamab Oncology  

Alphamab Oncology is a leading biopharmaceutical company in China dedicated to the development of innovative biologics for cancer therapy globally. So far, four drug candidates in Alphamab Oncology's pipeline 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 HEC Research Institute

HEC Group, located in China, is a conglomerate which develops, manufactures and markets products for global market. It has three business segments, including electronic materials, pharmaceuticals and healthcare, and two listed companies, HEC Science (600673.SH) and HEC Pharm (1558.HK). Founded in 2005, HEC Research Institute is committed to the research and development of innovative. So far, the Institute has a rich product pipeline with 18 clinical stage small molecule new drugs, of which 5 products have entered phase II/III clinical trials. By the end of 2018, 32 generic drugs developed independently by the Institute has entered Europe and the United States markets, within which 9 are patent-challenging and first generic drugs.

Visit http://www.hec.cn for more information.


Contacts:
Alphamab Oncology
Fengzhang Guan, +86-512-62850800 Extension 8807
fengzhangguan@alphamabonc.com