On June 2, 2020 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported the preliminary results of a Phase 1 clinical study (NCT03545971) of the recombinant fully human anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody (IBI310) in the form of online publication at the 56th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, JUN 2, 2020, View Source [SID1234560770]). (Online publication, Abstract # 302489)

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The NCT03545971 study is an open-label study and was consisted of two parts, namely Phase 1a study and Phase 1b study, which were designed to evaluate the tolerability, safety and anti-tumor activity of IBI310 and its combination with TYVYT (sintilimab injection) in the treatment of subjects with advanced malignant tumors, respectively. In the Phase 1a study, subjects with advanced solid tumors who have progressed from standard treatment were dosed with IBI310; while in the Phase 1b study, subjects with advanced melanoma were treated with IBI310 in combination with TYVYT (sintilimab injection). The main clinical data includes:

As of November 12, 2019, a total of 10 subjects were enrolled in Phase 1a study and 17 subjects were enrolled in Phase 1b study. There were no dose limiting toxicities (DLTs) in both phases, and the dose expansion in Phase 1b is currently ongoing. The most common treatment related adverse event (TRAE) was pruritus in both Phase 1a and Phase 1b studies, and no Grade 3 or higher adverse events occurred in Phase 1a and only one subject in Phase 1b experienced a grade 3 or higher TRAE (AST increased). There were no TEAE caused death.
In Phase 1b study, three subjects in the 3mg combination dose group had at least one tumor assessment and one of these subjects had objective response.
Professor Jun Guo, Vice President of Peking University Cancer Hospital and Director of the Department of Melanoma Medicine of Renal Cancer, said: "In recent years, several breakthroughs achieved in melanoma have brought more treatment methods for patients with melanoma. The 1-year survival rate of patients with advanced melanoma has been prolonged from 25% ~ 35% in the 1990s to 75% by today, and immunotherapy is one of the most critical breakthroughs for this improvement. The results of Checkmate-067 study showed that double immunotherapy for first-line treatment of advanced melanoma can significantly improve the prognosis compared to single immunotherapy. The preliminary results of NCT03545971 study show that IBI310 have acceptable safety profile and preliminary efficacy. We hope to see more positive data in the next studies."

Dr. Hui Zhou, Vice President of Medical Science and Strategic Oncology of Innovent, said: "CTLA-4 is an important immunosuppressive receptor, and there are a number of CTLA-4 related clinical studies on-going both in domestic and abroad, while currently only one has been approved. IBI310 is the CTLA-4 monoclonal antibody of fastest progress in China. The preliminary clinical results of IBI310 in combination with sintilimab show acceptable safety and anti-tumor activity, suggesting a synergistic enhancement effect. Currently, Phase 2/3 clinical studies of IBI310 in combination with sintilimab are on-going in multi tumors. We hope to evaluate the clinical results of IBI310 in combination with sintilimab and bring this therapy to more patients in need as soon as possible. "

About IBI310 (Anti-CTLA-4 Monoclonal Antibody)

IBI310 is a fully human monoclonal antibody blocking Cytotoxic T Lymphocyte-associated Antigen-4 (CTLA-4). CTLA-4 inhibits the immune escape of tumor cells and improves the body’s own immune response against tumor cells by up-regulating the anti-tumor immune response mediated by human effector T cells and weakening the immunosuppressive activity mediated by regulatory T cells, so as to achieve the purpose of treating a variety of tumors.