With the latest partnership, the Swiss drugmaker intends to expand its capabilities in the research and development of immuno-oncology therapeutics


Novartis headquarters in Basel, Switzerland. (Credit: Silesia711/Wikipedia.)

Novartis has entered into an option, collaboration and license agreement with Chinese biotechnology company BeiGene for the latter’s cancer drug ociperlimab.

The agreement expands the company’s existing collaboration and license deal signed earlier this year to develop, manufacture, and market BeiGene’s tislelizumab.

With the ociperlimab partnership, the Swiss drugmaker intends to expand its capabilities in the research and development of immuno-oncology therapeutics.

Under the terms of the agreement, Novartis will make an upfront payment of $300m, in exchange for development and marketing rights to ociperlimab in various countries.

The countries include the US, Canada, Mexico, the European Union (EU), UK, Norway, Iceland, Liechtenstein, Switzerland, Russia and Japan.

BeiGene would retain the rights to ociperlimab in China and all remaining countries. It is also responsible for providing half of the co-detailing efforts in the US, after regulatory approval.

Also, the Swiss drugmaker is liable to pay a fee of up to $700m to BeiGene, if its option is exercised after the agreed deadline of 2023.

Both companies would collaborate on the clinical development of ociperlimab in combination with tislelizumab, during the option period.

Novartis will be responsible for designing, sponsoring, conducting, and funding global combination clinical trials.

Novartis Oncology president Susanne Schaffert said: “This agreement adds a potentially transformative new therapy to our expanding immunotherapy platform and is part of the broad Novartis Oncology effort to drive the next wave of innovation in cancer treatments.

“Ociperlimab is a promising late-stage compound in non-small cell lung cancer, with potential in a wide range of solid tumours. We believe it is a strong candidate for potentially synergistic combination with the PD-1 inhibitor tislelizumab.

“We’re proud of the strong and innovative partnership we’ve established with BeiGene, as it builds on our previous collaboration with tislelizumab and will continue to help us reimagine medicine for people living with cancer.”

Ociperlimab is a late-stage T cell immunoreceptor with Ig and ITIM domains (TIGIT) inhibitor, a member of anti-cancer therapies that blocks the TIGIT protein receptor.

It is currently being studied in two Phase 3 trials AdvanTIG-301 and AdvanTIG-302 trials, in combination with tislelizumab, for treating advanced NSCLC.

The studies are in line with Novartis plan for the development of PD-1 inhibitor tislelizumab.

The two companies have also signed a strategic commercial agreement, under which BeiGene has agreed to promote a few Novartis’ oncology products in the China market.

The marketing partnership is expected to enhance Novartis Oncology’s presence in China.

In a separate development, Sandoz, a generics and biosimilar medicines subsidiary of Novartis, has submitted a Biologics License Application (BLA) to the US FDA for a potential biosimilar to EirGenix’ trastuzumab.

Trastuzumab is a monoclonal antibody intended to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers.