Date: 2017-03-24
Type of information: Establishment of a new subsidiary in the EU
Compound: two clinical-stage programs targeting the mechanistic target of rapamycin complex 1 (mTORC1) pathway
Company: PureTech Health (USA - MA) Novartis (Switzerland)
Therapeutic area: Immunological diseases
Type agreement: licensing
Action mechanism: mTOR inhibitor. Mechanistic target of rapamycin (mTOR) is a protein serine/threonine kinase that regulates multiple cell functions, including cell growth and metabolism, via two complexes: TORC1 and TORC2. Inhibition of the mTOR pathway has been shown to extend lifespan in multiple species studied including yeast, worms, flies and mammals, and to potentially ameliorate immunosenescence in aging animals and humans. TORC1 inhibition has been found to have many beneficial effects on aging, while TORC2 inhibition has been associated with adverse events including hyperglycemia and hypercholesterolemia. The immune-enhancing potential of mTORC1 inhibitors has been explored in a Phase 2 program at Novartis that included two successful Phase 2a studies in hundreds of elderly patients. The results of these studies form the foundation for further clinical development in immunosenescence and other aging-related diseases by targeting the mTOR pathway.
Disease: diseases related to immunosenescence
Details: * On March 24, 2017, PureTech Health announced a licensing and equity agreement with Novartis to advance two clinical-stage programs targeting the mechanistic target of rapamycin complex 1 (mTORC1) pathway. PureTech Health will develop these new product candidates in an operating subsidiary, resTORbio, with an initial focus on diseases related to immunosenescence, an age-related decline in immune function. The mTORC1 inhibitors being developed by PureTech Health potentially result in selective inhibition of mTORC1 and may therefore have therapeutic potential to ameliorate multiple aging-related conditions with a favorable safety profile. A Phase 2b study with these candidates is planned to commence in 2017. “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,” said Joe Bolen, PhD, Chief Scientific Officer for PureTech Health.
Financial terms: Under the terms of the agreement, PureTech’s resTORbio, will have an exclusive license to two clinical stage programs for aging-related indications. Novartis will receive equity in the resTORbio subsidiary and be eligible for future milestones payments and royalties based on a portion of net sales. PureTech Health has allocated approximately $15 million in several tranches to the development of the program as it progresses and continues to be de-risked. PureTech Health is expected to own approximately 58% of resTORbio on a diluted basis based on the allocation of $15 million. PureTech Health’s ownership may be increased over time to up to approximately 67% through the allocation of an additional $10 million to the program.
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