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 vivoformation 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’InvestigacionsBiomediques August Pi i Sunyer.
For Parvus Therapeutics
Justin Jackson, 212-213-0006, ext. 327
Source: Parvus Therapeutics Inc.
Nanotechnology Approach Restores Glucose Regulation and Motor Function in In Vivo Preclinical Models of Diabetes and Multiple Sclerosis, Respectively; Joint Swelling and Destruction Resolved in In Vivo Model of Rheumatoid Arthritis – – Parvus’ Approach Can Be Tailored to Treat Diverse Diseases
CALGARY, Alberta–(BUSINESS WIRE)–Parvus Therapeutics today announced the publication in Nature of a seminal paper describing the discovery and applications of a novel therapeutic approach employing nanomedicines, referred to as “Navacims”™, to reprogram white blood cells to become regulatory cells capable of blunting autoimmune responses and restoring the equilibrium of the immune system. Navacims are nanoparticles (NPs) coated with disease-relevant peptide-major histocompatibility complexes (pMHCs) that alter the behavior of pathogenic T lymphocytes by binding directly to their antigen receptors. The peer-reviewed article, titled “Expanding antigen-specific regulatory networks to treat autoimmunity” reports on a body of work, including results in multiple in vivo disease models, built on more than eight years of research by Parvus Founder and Chief Scientific Officer, Pere Santamaria, M.D., Ph.D.
Dr. Santamaria commented, “Autoimmune diseases, including type 1 diabetes, multiple sclerosis, and rheumatoid arthritis, are extraordinarily complex responses of our immune system against some of our own tissues (e.g. pancreas, brain and joints, respectively), leading to chronic organ inflammation, organ dysfunction, and, in some cases, premature death. Blunting these incompletely understood immune responses without suppressing the normal components of our immune system that protect us against infection and cancer is not currently possible.”
“However, our work offers a pharmaceutical solution to this fundamental problem,” Dr. Santamaria continued. “Navacims essentially re-program disease-causing white blood cells to become disease-suppressing cells, known as regulatory cells, leading to sustained therapeutic effects in various spontaneous and experimental autoimmune diseases, as reported in our article in Nature. Essentially, we have found that Navacims can be tailored to treat a wide range of autoimmune diseases, while sharing a common structure. Importantly, they have been shown to affect human white blood cells in the same manner as they do murine cells. Furthermore, Navacims have shown promising safety findings in preclinical in vivo models. Based on our results to date, we believe Navacims represent a therapeutic platform with broad-ranging health care implications.”
Findings being reported in Nature include:
“The findings being reported in Nature represent a scientific advance for Parvus and also a major achievement in the field of Immunology,” said Janice M. LeCocq, CEO of Parvus. “We believe that Dr. Santamaria’s work has the potential to transform the treatment of many of the more than 80 major autoimmune diseases affecting humankind, alleviating the suffering of millions of patients and their families. Over the coming year, we will be dedicating much of our in-house efforts to the advancement of our two lead programs for type 1 diabetes and multiple sclerosis.”
“Dr. Santamaria’s work to target the immune system dysfunction that causes type 1 diabetes represents the kind of innovative work that JDRF believes will eventually get us to a cure for this disease,” said Juvenile Diabetes Research Foundation Vice President of Discovery Research Julia Greenstein, Ph.D. “He and his colleagues have made exciting progress towards possibly developing a new class of drugs that could rebalance certain T-cells and ultimately provide a cure for type 1 diabetes and other autoimmune diseases as well.” The JDRF has funded the work of Dr. Santamaria and his colleagues at Parvus to explore Navacim-based treatments for diabetes.
Parvus’ strategy is to establish partnerships with major pharmaceutical companies to undertake the clinical and commercial development of many of its product pipeline candidates while also reserving rights to others suitable for its own development and commercialization. Parvus currently is engaged in late stage discussions with multiple pharmaceutical companies with regard to the type 1 diabetes (T1D) program. Manufacturing scale-up is now underway to supply upcoming preclinical and clinical studies.
The work being reported in Nature was led by Dr. Pere Santamaria and largely executed at the University of Calgary, Cumming School of Medicine (animal models of disease) and the Institutd’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) (humanized mouse work), with significant contributions from investigators at Institutions in Europe and the US. Further, Innovate Calgary, the technology-transfer and business-incubation center for the University of Calgary, provided early support for the transfer of the Navacims technology to and incubation of Parvus Therapeutics, which was organized as a separate entity in 2012.
Navacims are nanoparticles (NPs) coated with disease relevant peptide-major histocompatibility complexes (pMHCs). As opposed to other NP-enabled therapeutic strategies, Navacims operate by directly binding to pathogenic antigen-specific T lymphocytes via their antigen receptors and by reprogramming these cells to become disease-specific regulatory T cells. The resulting regulatory T cell population then goes on to suppress all other autoreactive lymphocytes partaking in the autoimmune disease process, without compromising systemic immunity. Navacims need not have to target prevalent or disease-triggering autoreactive T cell specificities to blunt a given autoimmune disease process.
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 disease-specific T- and B-regulatory cells resulting in the restoration of immune homeostasis. Navacims can be readily be tailored to target a broad range of autoimmune diseases and have the potential to radically improve the lives of patients suffering from these diseases.
Janice M. LeCocq, 850-724-0532
Chief Executive Officer