CALGARY, Alberta–(BUSINESS WIRE)–Parvus Therapeutics, a biopharmaceutical company developing disease-modifying nanomedicines to halt or reverse autoimmune disease without causing general immune suppression, has entered into a license and collaboration agreement with Novartis for its lead Navacim for treating type 1 diabetes. Navacims constitute a novel pharmacological class of therapeutic comprised of nanoparticles (NPs) coated with disease-relevant peptide-major histocompatibility complexes (pMHCs) that alter the behavior of disease-causing T lymphocytes. Navacims are the first biopharmaceuticals to demonstrate in preclinical models the ability to restore immune tolerance in a disease-specific manner through in vivo formation and expansion of regulatory T-cells (T-regs) without causing general immune suppression.
Under the terms of the agreement, Novartis receives exclusive, worldwide rights to use Parvus’ Navacim technology to develop and commercialize products for the treatment of type 1 diabetes (T1D) and will be responsible for clinical-stage development and commercialization activities. Parvus will be primarily responsible for conducting the ongoing preclinical work for the T1D program and filing the IND in collaboration with Novartis through a joint steering committee. Parvus has received an upfront payment and will receive research funding to support preclinical activities. In addition, Parvus is eligible to receive downstream development, regulatory, and sales milestone payments, as well as product royalties. Novartis has also made an equity investment in Parvus.
T1D Navacims are composed of an iron oxide nanoparticle conjugated with multiple copies of a peptide derived from a pancreatic autoantigen, presented in the context of an MHC molecule. Preclinical studies have shown that Navacims achieve their therapeutic effect by reprogramming cognate pathogenic T cells into tissue-specific beneficial T-regs and thereafter inducing their systemic expansion. The expanded T-regs target and suppress the autoimmune disease-causing immune cells, sparing other immune cells and restoring the immune system to the normal steady state. Navacims have the potential, therefore, to specifically treat the autoimmune disease without increasing the risk of infection.
“This is a transformative collaboration for Parvus. We are excited by this strong endorsement of the science behind our Navacim platform, as well as the opportunity to collaborate closely with a globally recognized leader in the field of immunology and autoimmune disease,” stated Janice M. LeCocq, CEO of Parvus. “This will augment our resources across the Navacim platform and accelerate the development of our T1D program. We are also pursuing the development of multiple Navacims that target autoimmune diseases where there is high unmet need for disease-modifying drugs without causing systemic immunosuppression.”
Type 1 diabetes (T1D) is caused by a chronic, progressive autoimmune response against the insulin-producing beta cells of the pancreas that ultimately leads to insulin-deficiency and high blood glucose levels. As a result, patients with T1D require insulin replacement therapy, usually involving multiple injections of insulin on a daily basis. Unfortunately, insulin is not a cure and does not treat the underlying cause of T1D. In addition, insulin replacement therapy cannot mimic the exquisitely tight control of glucose levels achieved by endogenous insulin production and, with time, can lead to serious complications, including blindness, stroke, myocardial failure, amputation and peripheral neuropathy. Currently, as many as 1.25 million Americans have T1D and the incidence of disease is steadily increasing. T1D is typically first diagnosed in children and young adults.
About Parvus Therapeutics Inc.
Parvus Therapeutics Inc. is a privately-held biopharmaceutical company engaged in the development and commercialization of Navacim therapeutics, novel nanoparticle based immune complexes that induce the in vivo expansion of specific regulatory cells resulting in the restoration of immune homeostasis. Navacims can be readily tailored to target a broad range of autoimmune diseases and have the potential to radically improve the lives of patients suffering from these diseases. Navacims were discovered by Pere Santamaria, M.D., Ph.D. Chief Scientific Officer and Founder of Parvus, Julia McFarlane Diabetes Research Professor of the Cumming School of Medicine at the University of Calgary and Group Leader at Institut D’Investigacions Biomediques August Pi i Sunyer.