On September 19, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize TEVIMBRA (tislelizumab) (Press release, BeiGene, SEP 19, 2023, View Source [SID1234635240]).

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"We are excited to regain the global rights to TEVIMBRA, which enables us to build out our in-house solid tumor commercial capabilities and complements our deep pipeline presented at our recent R&D Day. With more than 12,000 patients enrolled in our TEVIMBRA global clinical trial program, we plan to rapidly accelerate our regulatory and development plans across a wider range of tumor types," said John V. Oyler, Co-Founder, Chairman and CEO of BeiGene. "BeiGene will continue to work with Novartis on development, regulatory and manufacturing priorities. Novartis will manufacture TEVIMBRA for many markets worldwide and explore its potential in combination with their oncology assets."

BeiGene has launched more than 20 potentially registration-enabling trials with TEVIMBRA, of which 10 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts. Through these trials, TEVIMBRA has demonstrated its ability to safely deliver clinically meaningful improvements in survival benefits and quality of life for hundreds of thousands of cancer patients across a range of tumor types – in many cases, regardless of PD-L1 status – both as a monotherapy and in combination with other regimens. More than 750,000 patients have been prescribed TEVIMBRA to-date.

"TEVIMBRA is the backbone of our diverse solid tumor development pipeline focused on developing novel combination regimens with precision medicine targets – such as OX40, HPK1, and LAG3 – in our next wave immuno-oncology portfolio. It also nicely complements our diversified research portfolio, which includes additional modalities such as antibody drug conjugates and bispecific antibodies, many of which have blockbuster potential," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "We are eager to continue to explore TEVIMBRA’s full potential to address unmet clinical needs around the world, including in combination with our deep and diverse solid tumor pipeline, which has over 20 immuno-oncology and targeted molecules that could be paired with TEVIMBRA to help more patients."

Terms of the Agreement
The parties mutually agreed to terminate the previous collaboration and license agreement entered into on January 11, 2021, and, pursuant to the new agreement, BeiGene regained full global rights to TEVIMBRA with no royalty payments due to Novartis. In addition, Novartis will provide transition services and support to BeiGene to enable key aspects of the TEVIMBRA development and commercialization plan to proceed without disruption, including manufacturing, regulatory, safety and clinical support. BeiGene has agreed to provide Novartis with ongoing clinical supply of TEVIMBRA to support its clinical trials.

Under the previous agreement, BeiGene and Novartis were jointly developing TEVIMBRA in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. Under the agreement, Novartis was responsible for regulatory submissions and had the right to commercialize in these licensed countries following regulatory approval.

About TEVIMBRA (tislelizumab)
TEVIMBRA is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

TEVIMBRA is currently under review by the U.S. Food and Drug Administration and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. The EMA is reviewing a marketing authorization application for TEVIMBRA as a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated locally advanced or metastatic NSCLC. Regulatory submissions for TEVIMBRA are also under review by authorities in the U.K., Australia, China, New Zealand, Brazil, Korea, Switzerland, Israel and Indonesia. Tislelizumab is approved as a treatment in 11 indications in China and is the leading PD-1 inhibitor in the country.

The tislelizumab development program encompasses 21 registration-enabling clinical trials in more than 30 countries and regions. To date, BeiGene has announced positive readouts from 10 Phase 3 pivotal studies across multiple tumor types and disease settings such as NSCLC, small cell lung cancer, gastric cancer, ESCC, hepatocellular cancer, and nasopharyngeal cancer. More information on the clinical trial program for tislelizumab can be found at: View Source