Novartis Strengthens Its Immunotherapy Pipeline With Option, Collaboration And License Agreement With BeiGene For TIGIT Inhibitor Ociperlimab | Antibody


Novartis strengthens its immunotherapy pipeline with an option, collaboration and licensing agreement with BeiGene for ociperlimab, a TIGIT inhibitor

  • Ociperlimab Adds Innovative and Complementary Advanced TIGIT Inhibitor to Growing Oncology Portfolio
  • Two phase III trials underway in non-small cell lung cancer and additional studies underway in a wide range of solid tumors
  • Strategic Partnership Expands Development Opportunities with PD-1 Inhibitor Tislelizumab, a Potential Bridge to Synergistic Combinations in Novartis Immunotherapy Program
  • An innovative market development collaboration has also been signed, expanding the availability of certain Novartis oncology products in areas of China currently not covered by Novartis.

BASEL, Switzerland20 December 2021 – Novartis today announced the signing of an option, collaboration and license agreement with BeiGene, Ltd. for ociperlimab (BGB-A1217), expanding the company’s research and development activities in immuno-oncology. Ociperlimab is an advanced TIGIT inhibitor, a new class of cancer therapy that blocks the TIGIT protein receptor. Ociperlimab is currently being evaluated in two Phase III lung cancer trials and additional studies are underway in a wide range of solid tumors.

Under the agreement, Novartis will make an upfront payment of $ 300 million to BeiGene. A commission of up to $ 700 million would be paid to BeiGene if the option was exercised before the end of 2023. Upon exercise of the option, Novartis would obtain the rights to develop and commercialize the ociperlimab in the United States, Canada, Mexico and the European Union. , United Kingdom, Norway, Iceland, Liechtenstein, Switzerland, Russia and Japan. BeiGene is committed to providing 50% of the co-retail efforts in the United States after approval and will retain the rights to ociperlimab in China and all other countries.

“This agreement adds a potentially transformative new therapy to our expanding immunotherapy platform and is part of Novartis Oncology’s broader effort to lead the next wave of innovation in cancer treatments,” said Susanne Schaffert, PhD , President of Novartis Oncology. “Ociperlimab is a promising compound at an advanced stage in non-small cell lung cancer, with potential in a wide variety of solid tumors. We believe this is a strong candidate for a potentially synergistic combination with the PD-1 inhibitor, tislelizumab. We are proud of the strong and innovative partnership we have established with BeiGene, as it builds on our previous collaboration with tislelizumab and will continue to help us reinvent medicine for people living with cancer.

Ociperlimab is currently under investigation in Phase III trials for advanced non-small cell lung cancer, and its development complements Novartis’ development plan for the PD-1 inhibitor, tislelizumab. Early research suggests that TIGIT inhibitors may be active against a wide range of tumors, including cancer of the lung, esophagus, stomach, breast, and melanoma.

During the option period, Novartis and BeiGene will collaborate on the clinical development of ociperlimab in combination with tislelizumab, with Novartis designing, sponsoring, conducting and funding global combined clinical trials.

Novartis and BeiGene have also entered into a strategic business agreement whereby BeiGene will promote a number of Novartis oncology products in the large Chinese market, leveraging the operational resources and expertise of the BeiGene team in specific regions that are currently not covered by Novartis. Novartis will continue to market the same selected products and its broad portfolio in areas where it currently has a commercial presence. This market development partnership is expected to increase Novartis Oncology’s presence in China, where the company is committed to bringing new treatments to patients.

About ociperlimab and TGIT inhibition
An immune checkpoint molecule, ociperlimab is an experimental potent inhibitor of TIGIT with intact Fc function, considered essential for the anti-tumor activities of TIGIT antibodies.
Targeting of TIGIT provides a potential mechanism to rescue immune cells (eg, T cells, NK cells, and dendritic cells) from the immunosuppressive tumor microenvironment, to induce an effective anti-tumor immune response. The TIGIT pathway has been shown to cooperate with PD-1 to maximize suppression of immune cells infiltrating the effector tumor as well as to promote resistance to anti-PD-1 therapy. TIGIT represents a promising target with the potential to significantly improve and / or extend the therapeutic benefit of anti-PD-1 therapy to a larger number of patients.

Ociperlimab is currently being investigated in two global phase III clinical trials, AdvanTIG-301 and AdvanTIG-302, in combination with tislelizumab in non-small cell lung cancer. To date, approximately 600 patients have been enrolled in the ociperlimab development program, which includes six global trials in patients with lung cancer, squamous cell carcinoma of the esophagus and cervical cancer. ‘uterus.

Ociperlimab collaboration extends Novartis’ existing partnership with BeiGene
In an agreement signed earlier this year, BeiGene granted Novartis the rights to develop, manufacture and market tislelizumab in North America, Europe and Japan through a collaboration and license agreement. Tislelizumab is a humanized anti-PD-1 monoclonal antibody specially designed to minimize binding to FcγR on macrophages. In preclinical studies, it has been shown that binding to FcγR on macrophages compromises the anti-tumor activity of PD-1 antibodies by activating the destruction of effector cells by antibody-dependent macrophages. The clinical impact of these features is not yet known.

Novartis is advancing tislelizumab as a potential bridge to enable synergistic combinations, with the goal of extending the survival of more patients through novel combinations across tumors and treatment lines. Novartis owns the rights to develop, manufacture and market tislelizumab in North America, Europe and Japan through its collaboration and license agreement with BeiGene.

Novartis and lung cancer
Novartis is committed to working with the scientific and medical communities to reinvent the treatment of lung cancer and pursue medical advances that may prolong the survival of people with the disease. The company is developing experimental therapies that block the growth of cancer; learn more about ways to activate the body’s immune system; a better understanding of the relationship between chronic inflammation and the growth and progression of tumors; and explore the potential of advanced nuclear medicine to fight disease.

Lung cancer is one of the most common cancers in the world, accounting for more than 2 million new cases diagnosed each year. Each year, more people die from lung cancer than from any other cancer.

About Novartis
Novartis is reinventing medicine to improve and extend people’s lives. As a leading global pharmaceutical company, we use innovative scientific and digital technologies to create transformative treatments in areas of great medical need. In our quest for new drugs, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people worldwide and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world. Learn more about
https://www.novartis.com.

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Milton S. Rodgers