On October 10, 2019 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) and Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported the expansion of their global collaboration agreement to evaluate the safety and efficacy of Innovent’s Tyvyt (sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody, in combination with Chi-Med’s surufatinib, a novel inhibitor of vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor 1 (FGFR1) and colony stimulating factor-1 receptor (CSF-1R), in patients with advanced solid tumors (Press release, Innovent Biologics, OCT 10, 2019, https://www.prnewswire.com/news-releases/innovent-and-chi-med-expand-global-collaboration-to-evaluate-the-combination-of-sintilimab-and-surufatinib-in-solid-tumors-300936292.html [SID1234540941]). The expansion builds on the existing global collaboration agreement between the two companies on sintilimab in combination with Chi-Med’s highly selective VEGFR inhibitor, fruquintinib.
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The expansion of the global collaboration will allow Innovent and Chi-Med to jointly explore the potential application of Tyvyt and surufatinib combination therapy in solid tumors with global unmet medical needs. Clinical studies with this new combination will be conducted both in the United States and in China. The combination of Tyvyt and surufatinib is expected to have synergistic anti-tumor effects by simultaneously targeting multiple cell types and signaling pathways in the tumor microenvironment. Preclinical studies have suggested that surufatinib is able to inhibit angiogenesis, block the accumulation of tumor associated macrophages and promote infiltration of effector T cells into tumors, all of which could contribute to improve anti-tumor activity of Tyvyt.
"Sintilimab, co-developed by Innovent and Eli Lilly and Company, has gained broad recognition by the market, due to its profiles in safety and efficacy. Through partnership with other companies, we are exploring more sintilimab-based combination therapies. We already saw some promising results out of such combinations," said Dr. Michael Yu, Chairman and Chief Executive Officer of Innovent. "We are excited to further collaborate with Chi-Med to develop the combination therapy of sintilimab and surufatinib, hoping more patients will benefit from this potential therapy globally."
"We believe that the future of oncology treatments increasingly lies in combining therapies, utilizing multiple mechanisms of action to greatly improve the treatment of solid tumors," said Mr. Christian Hogg, Chief Executive Officer of Chi-Med. "Our unique next-generation anti-angiogenesis VEGFR inhibitors, with high selectivity and tolerability, make them ideal candidates for combinations with immunotherapy agents such as PD-1/L1 monoclonal antibodies. Our existing collaboration with Innovent on fruquintinib is progressing well. We are excited to expand our collaboration to include surufatinib and look forward to bringing the benefits of these combined therapies to more patients in China and around the world."
About Tyvyt (Sintilimab Injection)
Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including eight registration or pivotal clinical trials.
About Surufatinib
Discovered and developed solely by Chi-Med, surufatinib (previously known as HMPL-012 or sulfatinib) is a novel, oral drug candidate that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which both inhibit angiogenesis, as well as CSF-1R, which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib’s unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.
Surufatinib is in several late-stage and proof-of-concept clinical trials in China, for indications such as neuroendocrine tumors and biliary tract cancer. In June 2019, an interim analysis of a Phase III study in patients with non-pancreatic neuroendocrine tumors in China confirmed that the study had met its primary endpoint early. Detailed results from this study were orally presented at the 2019 European Society for Medical Oncology Congress on September 29, 2019, and preparations are underway for a New Drug Application submission in China.
Surufatinib is also in proof-of-concept clinical trials in the United States. Chi-Med currently retains all rights to surufatinib worldwide.