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Novartis brings on first TIGIT drug in massive billion-dollar biobucks deal with BeiGene

After watching Gilead Sciences and Roche dive deeper into TIGIT immunotherapies, Novartis is heading straight for the senior class. The Swiss pharma is getting in on the game via a blockbuster deal with BeiGene, which could ultimately net $1 billion for a late-stage asset.

Novartis will pay $300 million upfront and could shell out up to $700 million down the line in milestones for the TIGIT inhibitor ociperlimab if an option is exercised before 2023, according to a Monday statement. This is Novartis’ first TIGIT therapy, and a late-stage asset at that, the company confirmed this morning.

TIGIT, or T-cell immunoreceptor with immunoglobulin and ITIM domain, is a promising new target for cancer immunotherapy that provides the possibility to rescue immune cells such as T cells, natural killer cells and dendritic cells from the immunosuppressive tumor microenvironment. That means the therapy is expected to induce an efficient anti-tumor response.

BeiGene has been testing ociperlimab in two phase 3 non-small cell lung cancer (NSCLC) trials called AdvanTIG-301 and AdvanTIG-302 in combination with tislelizumab, an anti-PD-1 antibody that is approved for several uses in China. Novartis is developing tislelizumab in North America, Europe and Japan through an agreement with BeiGene that was signed in January.

RELATED: BeiGene’s Novartis-partnered PD-1 drug hits goal in phase 3

Early research on TIGITs suggests they could target a range of tumors including those in the lungs, esophagus, gastric, breast and melanoma. BeiGene said that 600 patients have been enrolled in trials featuring ociperlimab in lung cancers, esophageal squamous cell carcinoma and cervical cancer.

Susanne Schaffert, Ph.D., president of Novartis Oncology, said ociperlimab and tislelizumab go hand in hand.

This new tie-up will expand the previous one for tislelizumab and also give BeiGene Chinese marketing rights to five approved Novartis meds: Tafinlar, Mekinist, Votrient, Afinitor and Zykadia. The deal also allows Novartis to expand into a region not currently covered by its oncology program.

Novartis and BeiGene will work together on clinical development of the ociperlimab and tislelizumab combo. All of the milestones in the deal are contingent on Novartis optioning ociperlimab by 2023. If that happens, the Big Pharma will have development and commercialization rights in a handful of important markets including the U.S., Canada, EU, U.K. and more. BeiGene will provide half of the codetailing efforts in the U.S. upon approval and will still hold rights to the therapy in China and all other countries not listed in the deal.

RELATED: Roche posts ‘impressive’ TIGIT combo lung cancer data, but trial deaths weigh down shares

If the combination is approved, the collaboration may continue with new clinical studies of ociperlimab in combination with other medications, according to BeiGene.

TIGITs have drawn huge bucks and interest from Novartis’ Big Pharma peers. Roche is trialing a combination of tiragolumab with Tecentriq in certain lung cancers. The combo showed that it can shrink tumors compared to Tecentriq alone, but more recent data were plagued by two deaths in the combo arm.

Then there’s Gilead, which recently doubled down on a partnership with Arcus that includes a TIGIT asset called domvanalimab, which is in phase 2 and 3 trials for NSCLC in combination with another TIGIT dubbed AB308. But Gilead stopped short of a full buyout with Arcus, which was on the table through the $3 billion licensing deal.

GlaxoSmithKline also made a move into the drug class in June through a $625 million upfront licensing deal with iTeos Therapeutics for the phase 1 anti-TIGIT monoclonal antibody EOS-448. Bristol Myers Squibb and Merck & Co. also have TIGIT assets under development.

Annalee Armstrong

https://www.fiercebiotech.com/biotech/novartis-brings-1st-ever-tigit-drug-massive-billion-dollar-biobucks-deal-beigene

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