After facing regulatory roadblocks, Novartis is returning the anti-PD-1 antibody to the cancer-focused biotech, which regains global rights to develop, manufacture and commercialize tislelizumab.
Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto
Novartis on Tuesday gave back the investigational monoclonal antibody tislelizumab to BeiGene, returning worldwide rights to develop, manufacture and commercialize the anti-PD-1 candidate to the cancer-focused biotech.
Also on Tuesday, BeiGene announced that the European Commission had approved tislelizumab for patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had previously failed platinum-based chemotherapy. The treatment will be marketed under the brand name Tevimbra.
After more than a year of regulatory delay, the FDA has also accepted BeiGene’s Biologics License Application (BLA) for tislelizumab as a first-line treatment option in this indication, according to Tuesday’s announcement.
Novartis and BeiGene first entered into a collaboration and license agreement over tislelizumab in January 2021 to develop tislelizumab in ESCC, as well as other malignant diseases such as non-small cell lung cancer and hepatocellular carcinoma.
In July 2022, however, the partners ran into a regulatory roadblock when the FDA decided to defer its action on tislelizumab’s BLA in ESCC until after it had completed an inspection of the company’s facilities in China. A year later, during its R&D day in July 2023, BeiGene announced that the FDA had completed its site inspections, Endpoints News reported.
As part of Tuesday’s hand-off, the companies have mutually agreed to terminate their 2021 contract. Instead, they have inked a new deal that will see Novartis provide transition services to BeiGene in order to avoid disrupting tislelizumab’s development and commercialization plans. This includes manufacturing, regulatory, clinical and safety support. In return, BeiGene will also continue to provide Novartis with tislelizumab supplies for its clinical trials.
With tislelizumab fully within BeiGene’s portfolio again, the company plans to accelerate its regulatory and development plans for the candidate, as well as study its therapeutic potential across a wider range of cancer types, CEO John Oyler said in a statement.
While Novartis is returning the rights to tislelizumab, BeiGene will nevertheless keep working with the Swiss pharma group on “development, regulatory and manufacturing priorities,” Oyler said. “Novartis will manufacture Tevimbra for many markets worldwide and explore its potential in combination with their oncology assets.”
Tislelizumab is a humanized monoclonal antibody that binds to the PD-1 protein and prevents it from interacting with Fc-gamma receptors on macrophages. In turn, tislelizumab helps the body’s immune system to exert its anti-cancer effects and attack tumor cells. The treatment is approved in 11 indications in China, where it also bears the brand name Tevimbra.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
