Novartis Licenses BeiGene’s Antibody for a Potential $2.8 Billion After Its Own Drug Disappoints

Novartis is exploring new possibilities for its immuno-oncology pipeline, having struck a deal worth around $2.8 billion with Beijing-based BeiGene to license ociperlimab, a late-stage TIGIT inhibitor. The same day, the Swiss drug giant had posted disappointing trial results on their own antibody, ligelizumab, in an autoimmune disease. 

Under the agreement, Novartis will pay BeiGene $300 million upfront to get an option to co-develop ociperlimab, while BeiGene will get an additional $600 or $700 million if Novartis exercises the option before late 2023. Novartis will conduct and fund clinical trials of ociperlimab in combination with tislelizumab in a variety of tumor types, and help file for approval of the drug in the licensed territory, which includes the US, the EU, and Japan. BeiGene could stand to receive $1.9 billion in regulatory and sales milestones.  

Furthermore, BeiGene gets the rights to market five Novartis’ commercialized anticancer drugs in China. The drugs are: Tafinlar (dabrafenib), Mekinist (trametinib), Votrient (pazopanib), Afinitor (everolimus) and Zykadia (ceritinib). 

“Ociperlimab is a promising late-stage compound in non-small cell lung cancer, with potential in a wide range of solid tumors,” said Susanne Schaffert, President of Novartis Oncology, adding that ociperlimab could potentially synergize with tislelizumab, a PD-1 inhibitor licensed from BeiGene in January.   

Ociperlimab in Immune Cell Rescue and Antitumor Activity 

Originally discovered by BeiGene, ociperlimab is an investigational IgG 1 monoclonal antibody that inhibits TIGIT. The TIGIT pathway is known to work with PD-1, an immunosuppressive protein, to suppress tumor infiltrating immune cells. By blocking TIGIT, ociperlimab rescues these immune cells and allows them to carry out their anti-tumor activity. 

Ociperlimab is being investigated in combination with tislelizumab in two global Phase 3 clinical trials in non-small cell lung cancer (NSCLC). The combination immunotherapy is also involved in eight other early- and late-stage trials covering cancers of the lung, liver, esophagus, and cervix. 

Novartis’ Ligelizumab Fails to Beat Standard of Care

Novartis is in need of more successes in its immuno-oncology pipeline. The company announced that its ligelizumab failed to show superiority to the standard of care, omalizumab, in the treatment of chronic spontaneous urticaria (CSU), an autoimmune disease which causes the skin to recurrently break out in hives. 

Results from an extended Phase 2b study had suggested that ligelizumab could induce earlier and better outcomes than omalizumab in patients previously treated with omalizumab. 

However, top-line results of ligelizumab from the Pearl 1 and Pearl 2 Phase 3 studies showed that while the treatment met the primary endpoint of superiority over placebo at Week 12, it was not superior to omalizumab. 

“We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU,” said John Tsai, head of global drug development and chief medical officer at Novartis. “We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is a significant unmet need.” 

A full readout of Pearl 1 and Pearl 2 is expected in the second half of 2022, when the trials complete, said Novartis.

Author

Joy Lin

Without knowledge, there is no imagination. Without imagination, knowledge is meaningless