Program to initially focus on aging-related disorders
Phase 2b clinical study to commence in 2017
BOSTON--(BUSINESS WIRE)-- PureTech Health plc (LSE: PRTC), 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
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. 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 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.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is a cross-disciplinary advanced clinical stage biopharmaceutical company developing novel medicines that modulate the adaptive human systems. Our therapies target the dysfunctions in the immune, nervous, and gastro-intestinal systems by addressing the underlying pathophysiology of disease from a systems perspective rather than through a single receptor or pathway. We are advancing a rich pipeline that includes multiple human proof-of-concept studies and pivotal or registration studies expected to read out over the next two years. PureTech Health's growing research and development pipeline has been developed in collaboration with some of the world's leading scientific experts, who along with PureTech's experienced team and a stellar board analyze, identify and advance very selectively the opportunities the Company believes hold the most promise for patients. This experienced and engaged team and process place PureTech Health at the forefront of ground-breaking science and technological innovation and leads the Company between and beyond existing disciplines. For more information, visit www.puretechhealth.com or connect with us on Twitter @PureTech.
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This announcement contains inside information.
iThe ownership determination includes issued and outstanding shares as well as options to purchase shares and written commitments to issue shares or options, but excludes unallocated shares authorized to be issued pursuant to equity incentive plans and any convertible debt.
Source: PureTech Health plc
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