Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that its IND application for IBI101, a recombinant fully human anti-OX40 monoclonal antibody (mAb) drug candidate, has been approved by the US Food and Drug Administration (FDA), and plans to initiate the US phase I clinical trial based on results from the China phase I study in patients with advanced solid tumors.
IBI101 is the third molecule from Innovent approved for clinical trials by FDA. The company also has received FDA IND approvals for IBI308 (Sintilimab, an anti-PD-1 antibody) in January, 2018 and IBI188 (an anti-CD47 antibody) in September, 2018 respectively. Innovent is the first Chinese biopharmaceutical company to receive clinical trial approval from FDA for an anti-OX40 monoclonal antibody.
“Innovent was built according to international R&D and production standards and has been exploring the latest cutting-edge research in the area of biopharmaceutical development. The FDA IND approval of anti-OX40 monoclonal antibody once again demonstrates Innovent’s research and development capability. We hope that through our efforts, we can make more breakthroughs in the field of innovative biopharmaceuticals and benefit patients around the world,” said Michael Yu, Founder, Chief Executive Officer and Chairman.
IBI101 is a recombinant fully human anti-OX40 (tumor necrosis factor receptor superfamily member 4) monoclonal antibody. IBI101 was developed by Innovent and has independent intellectual property rights. Pre-clinical data confirm that IBI101 can significantly enhance the activation of effector T cells and mediate the clearance of regulatory T cells, thus inhibiting the growth of tumor cells. Compared with other published antibodies with same target, IBI101 has a stronger ability to activate T cells and generate anti-tumor effects. Agonistic OX40 candidates will be used in combination with other immunomodulation agents, including anti-PD-1 monoclonal antibody (IBI308) and other drugs in Innovent’s R&D pipeline, to meet more unmet medical needs of cancer patients. At present, no monoclonal antibody targeting OX-40 has been approved for marketing worldwide.
IBI188 is an anti-CD47 IgG4 monoclonal antibody developed by Innovent and has independent intellectual property rights. Both in vitro and in vivo experiments show that IBI188 can bind to the CD47 antigen on the surface of tumor cells, block the CD47-SIRPα signaling pathway, inhibit the “Don’t Eat Me” signal, and promote the phagocytosis of tumor cells by macrophages, thereby exerting an anti-tumor effect. Innovent will launch several clinical trials to assess its safety and efficacy for multiple tumor types, including non-Hodgkin’s lymphoma and ovarian cancer.
About IBI308 (Sintilimab)
Sintilimab (IBI308) is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, successor to CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin’s Lymphoma.
Inspired by the spirit of “Start with Integrity, Succeed through Action”, Innovent’s mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Since its establishment from 2011, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities, and a pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune and metabolic diseases. Innovent has built up a pipeline of 17 antibody drug candidates, with four core products in late-stage clinical development in China and two that have New Drug Applications (NDA) accepted by the NMPA including one with priority review status.
Innovent has a highly talented international team, including many expert returnees with experience in innovative biopharmaceutical drug discovery, development, production and commercialization. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, and other biopharmaceutical companies. Innovent wishes to work with all relevant parties helping the advancement of China’s biopharmaceutical industry, so as to improve drug availability to people and address their aspiration for a healthy, happy life.
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