PureTech Health, an advanced clinical stage biopharmaceutical company, today 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. A Phase 2b study with these candidates is planned to commence in 2017.
“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,” said Joe Bolen, PhD, Chief Scientific Officer for PureTech Health. “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.”
Immunosenescence, the age-dependent decline in immune function, is associated with a decreased ability to fight infections, an increase in cancer incidence and a decline in organ function in the elderly. With a rapidly aging population, there is a significant need to address aging-related diseases and conditions. 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.
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. Results will be detailed in an upcoming peer-reviewed publication. The results of these studies form the foundation for further clinical development in immunosenescence and other aging-related diseases by targeting the mTOR pathway.
“Drug discovery and development is a team sport and we are excited to enter into this agreement with the seasoned leadership at PureTech Health,” said Jay Brander, M.D., President of the Novartis Institutes for Biomedical Research (NIBR). “We regard the further development of these compounds by PureTech Health for the potential treatment of conditions such as immunosenescence, as a prime example of our continued commitment to work more openly with innovators beyond our walls to advance projects that have the potential to help patients lead healthier lives.”
“mTORC1 inhibitors could lead us to a new paradigm for treating several aging-related conditions,” said Chen Schor, a PureTech Senior Executive and the leader of the resTORbio program. “We have a robust clinical development plan for the first indication and plan to explore the program across multiple aging-related diseases.”
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.i