22 December 2021 | Wednesday | News
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Strategic collaboration expected to advance clinical development of ociperlimab in combination with tislelizumab, including initiation and funding by Novartis of additional studies
BeiGene expands commercial portfolio in China broad markets with marketing rights for five Novartis Oncology products
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global science-driven biotechnology company, today announced an option, collaboration and license agreement with Novartis Pharma AG to develop, manufacture and commercialize BeiGene’s investigational TIGIT inhibitor ociperlimab in North America, Europe, and Japan. In addition, the parties entered into an agreement granting BeiGene rights to market, promote and detail five approved Novartis oncology products, TAFINLAR® (dabrafenib), MEKINIST® (trametinib), VOTRIENT® (pazopanib), AFINITOR® (everolimus), and ZYKADIA® (ceritinib), across designated regions of China referred to as “broad markets.”
Building upon the collaboration between BeiGene and Novartis for anti-PD1 antibody tislelizumab announced in January 2021, BeiGene has granted Novartis an exclusive time-based option under which, upon exercise by Novartis prior to late 2023, the companies have agreed to jointly develop ociperlimab, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals in the licensed territory. During the option period Novartis will conduct and fund additional global clinical trials of ociperlimab in combination with tislelizumab in selected tumor types. In addition, following option exercise, both companies may conduct clinical trials globally to explore combinations of ociperlimab with other cancer treatments. Following approval, BeiGene will co-detail the product in the United States.
Ociperlimab is an investigational potent TIGIT inhibitor with intact Fc function, believed to be critical for the anti-tumor activities of TIGIT antibodies. An immune checkpoint molecule, ociperlimab is currently being investigated in two global Phase 3 clinical trials, the AdvanTIG-301 and AdvanTIG-302 trials, in combination with tislelizumab in NSCLC. To date, approximately 600 subjects have been enrolled across the ociperlimab development program, which includes six global trials in patients with lung cancers, esophageal squamous cell carcinoma, and cervical cancer.
“We are excited to expand our productive collaboration with Novartis to include the development of ociperlimab, one of the most advanced TIGIT inhibitor programs. Building on the work accomplished with Novartis on the tislelizumab program, we are excited to explore additional synergies among our pipelines, and to potentially expedite access to ociperlimab,” said John V. Oyler, Co-Founder, CEO, and Chairman of BeiGene. “In addition, our strong science-based commercial team in China, which is now more than 3,100 people, is well positioned to help deliver the five Novartis oncology medicines to the patients who need them across parts of China. This multi-faceted and important collaboration stands on the strong foundation our companies have built together, and our shared commitment to serving patients around the world.”