SUZHOU, China—Innovent Biologics, Inc. has announced that the company has entered into a strategic research and development collaboration with Roche Holding AG. The partnership covers multiple cell therapies and bispecific antibodies, and will focus on the discovery, clinical development and commercialization of bispecific antibodies and multiple cell therapies, directed toward the treatment of hematological and solid cancers.
“Innovent first entered the cellular therapy space a few years ago, and with this partnership with Roche we are taking a much bolder step forward as we build upon Roche’s novel, universal CAR-T cell technology to enhance our cellular therapy discovery platform, and on Roche’s 2:1 T-cell bispecific antibody platform for selected targets to discover, develop, and commercialize new proprietary bispecific molecules. We are excited about working together as we rapidly advance these technologies to proof of concept stage in China,” said Dr. Michael Yu, who is founder, chairman and CEO of Innovent Biologics.
Under the terms of the agreement, Innovent will pay upfront, development and commercial milestone payments, as well as royalties, to non-exclusively access certain Roche technologies that enable the discovery and development of specific 2:1 T-cell bispecific antibodies and the universal CAR-T platform. Innovent will create, develop, manufacture and commercialize the products.
Roche retains an option right to license each product for ex-China development and commercialization. Should Roche exercise all of its options, it will pay option exercise payments totaling $140 million plus additional development, approval and sales milestone payments up to $1.96 billion if all products are successfully developed and commercialized. Roche will also pay up to mid teen double-digit percentage royalties on each product.
In other news from both companies, Roche recently reported that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the company’s Elecsys IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6), and can be used to help identify patients with confirmed COVID-19 who could be at high risk of intubation with mechanical ventilation.
“The FDA EUA approval of Elecsys IL-6 is another step in our commitment to deliver fast and reliable diagnostic tests to help fight the coronavirus pandemic,” explained Thomas Schinecker, CEO of Roche Diagnostics, in a press release. “In the current situation, time is specifically critical. The test could help physicians in the quick identification of severe inflammatory response in patients infected with the SARS CoV-2 virus.”
The Elecsys IL-6 test can be run on Roche’s Cobas E analyzers, which are widely available. The fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour dependent upon the analyzer.
And Innovent just announced the preliminary results of a Phase 1 clinical study of the recombinant fully human anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody, known as IBI310, in the form of online publication at the 56th American Society of Clinical Oncology Annual Meeting.
“In recent years, several breakthroughs achieved in melanoma have brought more treatment methods for patients with melanoma,” stated Professor Jun Guo, vice president of Peking University Cancer Hospital and director of the Department of Melanoma Medicine of Renal Cancer. “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.”
The study is open-label, consisting of two parts. In the Phase 1a study, subjects with advanced solid tumors who have progressed from standard treatment were dosed with IBI310. In the Phase 1b study, subjects with advanced melanoma were treated with IBI310 in combination with TYVYT (sintilimab injection).
As of November 2019, 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. 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). In the Phase 1b study, three subjects in the 3mg combination dose group had at least one tumor assessment, and one of these subjects had an objective response.
“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,” noted Dr. Hui Zhou, vice president of Medical Science and Strategic Oncology at Innovent. “Currently, Phase 2/3 clinical studies of IBI310 in combination with sintilimab are ongoing in [multiple] 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.”