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.”