Novartis offloads phase 2 mTORC1 programs to PureTech

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PureTech plans to test the Novartis' mTORC1 assets in diseases linked to immunosenescence.

Novartis has offloaded two midphase mTORC1 inhibitors to PureTech Health. The agreement will see PureTech create a subsidiary, resTORbio, to move the assets into a phase 2b trial in diseases linked to the age-related deterioration of the immune system.

Under the terms of the deal, Novartis is gaining an equity stake in resTORbio and a source of future milestones and royalties. PureTech will handle the heavy lifting from here on out. The Boston-based company—which is listed on the stock exchange in London—has allocated $15 million (€14 million) to development of the candidates, a commitment that will give it a 58% stake in resTORbio. PureTech could up its stake to 67% by putting a further $10 million into its subsidiary.

The first tranches of funding will enable resTORbio to set up and a run a phase 2b trial. PureTech is initially focusing on diseases linked to immunosenescence, the process through which the body’s ability to fight infections and develop immune memory declines with age.

Novartis’ work on mTORC1—an abbreviation of mechanistic target of rapamycin complex 1—is best known for everolimus, a drug sold as Afinitor or Zortress depending on whether it is being used in cancer or transplant patients. But the Swiss Big Pharma and other companies including 2014 Fierce 15 winner Navitor Pharmaceuticals have also explored research showing inhibition of the mTOR pathway extends the lifespan of mice—while delaying the onset of age-related diseases—and boosts the efficacy of vaccines.

This led Novartis to test everolimus in elderly volunteers. A paper published in 2014 showed the drug boosted immune responses to flu vaccines by around 20%. Novartis is set to publish more data on the use of mTORC1 inhibitors in elderly patients. And PureTech, having taken a look at the results, thinks the approach warrants further investigation.

“Impairment of adaptive and innate immune system robustness underlies age-associated immunosenescence. Inhibition of the mTORC1 pathway has proven to be effective in re-establishing T-cell composition and function, which in turn can revitalize immune homeostasis,” PureTech CSO Joe Bolen, Ph.D., said in a statement.

Novartis saw the same evidence but decided it was best served by handing off responsibility for further development.

The deal is reminiscent of an agreement Novartis struck with Phase 4 Partners and institutional investors in 2015. That transaction spun off three of Novartis’ midphase assets to create a British biotech, Mereo BioPharma. In return for the assets, Novartis took an equity stake in Mereo and put itself in line to receive milestones and royalties as the programs advance.

In both cases, Novartis has moved midphase programs off its balance sheet while keeping a way to profit from their progress and potential commercial success. Mereo was founded in the belief pharma company pipelines are stocked with more midphase clinical assets than they can afford to develop. And, while Mereo is yet to grow its pipeline beyond the three ex-Novartis assets, the deal with PureTech shows at least one Big Pharma is still interested in trimming its pipeline.