US-based Puretech Health has signed a licensing and equity agreement with Swiss company Novartis to advance two clinical-stage programmes targeting the mechanistic target of rapamycin complex 1 (mTORC1) pathway.
The new product candidates will be developed by PureTech in an operating subsidiary resTORbio, with a focus on diseases related to immunosenescence, an age-related decline in immune function.
Immunosenescence is associated with a decreased ability to fight infections, an increase in cancer incidence and a decline in organ function in the elderly.
PureTech and Novartis plan to start a Phase IIb study with these candidates this year.
PureTech Health chief scientific officer Joe Bolen said: “Consistent with our strategy of addressing the impairments of the brain, gut and immune systems, targeting the mTORC1 pathway offers us a compelling opportunity to address conditions impacting these adaptive systems.
“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 revitalise immune homeostasis.”
As part of a Phase II programme at Novartis, the immune-enhancing potential of mTORC1 inhibitors has been explored.
The programme included two successful Phase IIa studies in elderly patients.
The results from these studies will help the foundation of further clinical development in immunosenescence and other aging-related diseases by targeting the mTOR pathway.
Under the agreement, resTORbio will have an exclusive license to two clinical stage programmes for aging-related indications.
Novartis will receive equity in the subsidiary and is also eligible for future milestones payments and royalties based on a portion of net sales.
For the programme development, PureTech Health has allocated approximately $15m in several tranches and is expected to own about 58% of resTORbio on a diluted basis based on the allocation.