Parvus Eligible to Receive Upfront and Milestone Payments Exceeding $800 Million Plus Royalties on Net Sales

BURLINGAME, Calif. & CALGARY, Alberta–(BUSINESS WIRE) –- May 16, 2019 — Parvus Therapeutics, a biopharmaceutical company focused on the development of disease-specific immunoregulatory medicines to treat autoimmune diseases without impairing normal immunity, has entered into a worldwide collaboration and license agreement with Genentech, a member of the Roche Group, to develop, manufacture, and commercialize novel Navacim™ therapeutics for the treatment of inflammatory bowel disease (IBD), autoimmune liver diseases (ALD), and celiac disease (CD). Parvus will receive an undisclosed upfront payment and is eligible to receive research, development and commercialization milestone payments for each disease area within the collaboration, based on achievement of certain predetermined milestones. Parvus is also eligible to receive certain additional milestone payments in other disease areas, as well as royalties on net sales of products resulting from the collaboration.

“Our collaboration with Genentech is now the second partnership that we’ve entered into with a major biopharmaceutical company, which we believe reinforces the potential of our Navacim immunoregulatory therapeutic platform,” said Curtis Ruegg, Ph.D., President & CEO of Parvus. “Partnering with Genentech will enable Parvus to expand the Navacim pipeline to address several debilitating autoimmune diseases in gastroenterology.”

Under the terms of the Agreement, Parvus will conduct pre-clinical development and clinical development activities through Phase I. Genentech will be responsible for clinical development from Phase II and beyond, including global regulatory submissions and worldwide commercialization of products.

“Parvus’ technology represents a potentially transformative approach for treating autoimmune diseases by inducing immune tolerance without causing generalized immune suppression,” said James Sabry, M.D., Ph.D., Global Head of Pharma Partnering, Roche. “In preclinical testing, Parvus’ platform has shown the ability to induce and expand disease-specific regulatory T cells, which restore immune system balance and halt the autoimmune disease process. We look forward to working with the Parvus team to hopefully bring this exciting advancement to patients.”

About Navacims™
Navacims are a precision medicine platform designed to trigger a naturally occurring immunoregulatory mechanism of the mammalian immune system which has evolved to protect against autoimmune disease. As selected for each disease, Navacims present a singular, peptide-major histocompatibility complex (pMHC) at supra-physiological density, targeting cognate T cell receptors (TCR) on disease relevant T cells. Navacim binding causes a sustained assembly of TCR microclusters and prolonged signaling leading to disease-specific type 1 regulatory T (TR1) cell differentiation. Because Navacim activity depends on the presence of disease-causing, autoimmune T cells, their action is self-limiting. In preclinical disease models, Navacims have demonstrated broad therapeutic activity and disease reversal across a range of autoimmune disorders including diabetes, multiple sclerosis, ALD and IBD while consistently preserving immunocompetence to resist viral, microbial, and tumor challenges.

About Parvus Therapeutics Inc.
Parvus Therapeutics Inc. is a privately-held biopharmaceutical company engaged in the development and commercialization of Navacim therapeutics targeting autoimmune diseases. Navacims were discovered by Pere Santamaria, M.D., Ph.D. Chief Scientific Officer and Founder of Parvus, Julia McFarlane/Diabetes Canada Professor of the Cumming School of Medicine at the University of Calgary.

Contacts

Media
Burns McClellan
Nancie Steinberg / Robert Flamm
212-213-0006 x318 / 212-213-0006 x364
nsteinberg@burnsmc.com / rflamm@burnsmc.com

  Source: Parvus Therapeutics

— Peter M. Strumph, Chief Executive Officer

— Brendan Classon PhD, Executive Vice President, Research and Development

— Louis Demers, Vice President of Technical Operations

— Matthew J. Hogan, member of the Board of Directors

SOUTH SAN FRANCISCO, CALIFORNIA & CALGARY, Alberta  — July 6, 2021 — Parvus Therapeutics, a biopharmaceutical company focused on the development of medicines using the proprietary platform-based, disease-specific immunoregulator, Navacims, to treat autoimmune diseases without impairing normal immunity, today announced the appointment of Peter Strumph as Chief Executive Officer and a member of the Board of Directors, Matthew J. Hogan as a member of the Board of Directors, Brendan Classon as Executive Vice President, Research and Development, and Louis Demers as Vice President of Technical Operations.

“Parvus’ Navacim technology has the promise to deliver treatments for many autoimmune diseases, with primary biliary cholangitis (PBC) as the first indication. The Board of Directors is confident this leadership team has the skills and experience to execute the Parvus strategy to bring our first Navacim into the clinic and soon, other Navacims™ for additional indications,” said Hugh Young Rienhoff, Jr. MD, Chairman of the Board.

“Recent progress has been made in developing our Navacim platform, specifically improvements to meet manufacturability requirements and the generation of the production cell line to support our lead PBC clinical program,” stated Peter Strumph, CEO. “I am thrilled to assume this leadership role at Parvus, to be given the opportunity to build the company, and to develop a series of Navacim based products to address the unmet need of patients afflicted with autoimmune disease.”

Peter Strumph has more than two decades of experience in executive leadership and technical roles supporting successful development and commercialization of 7 FDA approved novel therapies. Peter’s prior experience includes CEO at Amygdala Neurosciences, CEO at Codexis, SVP of Operations at Portola Pharmaceuticals, SVP of Operations at CV Therapeutics, and manager of Operations & Planning at Biogen. Peter served as a Lieutenant in the US Navy, earned a BAS in Systems Engineering from the University of Pennsylvania and earned an MBA from the Wharton School.

Brendan Classon has more than two decades of biopharmaceutical industry experience in discovery, research, and preclinical development of small molecule and biologic therapeutics for autoimmune disease. Brendan has held positions of increasing responsibility in research leadership at Genocea Biosciences, Kiniksa Pharmaceuticals, Novo Nordisk, Sanofi, Regeneron Pharmaceuticals and Bristol-Myers Squibb. Brendan earned a BS with Honors from Monash University and a PhD in Immunology from The University of Melbourne.

Louis Demers has more than two decades of experience in the biopharma industry with large and small companies like J&J, Genentech/Roche, XOMA, and, most recently, Rezolute. Louis has managed CMC programs across a wide array of technologies with a focus on large molecules and Antibody-Drug Conjugates. He is experienced in setting up and managing virtual global supply chains to advance pre-clinical, clinical commercial manufacturing. Louis earned a BE in Chemical Engineering from McGill University in Montreal and an MBA from the UC Berkeley Haas School of Business.

Matt Hogan has extensive experience in the field of healthcare corporate finance. Matt served as the CFO of DURECT Corporation from 2006 to 2018 and serves as a corporate finance advisor to DURECT and other biopharmaceutical companies. Prior to joining DURECT, Matt was the CFO of Ciphergen Biosystems, Avocet Medical, and Microcide Pharmaceuticals. Matt has also held positions as an investment banker with Merrill Lynch for ten years and a commercial banker with Manufacturers Hanover Trust. Matt earned a BA in Economics, cum laude, from Dartmouth College and an MBA from the Amos Tuck School of Business Administration.

About Navacims
Navacims are a novel first-in-class nanomedicine designed to treat autoimmune disease by selectively modulating disease-specific cellular responses without impairing normal immunity. Navacims specifically target and act only on disease causing effector T cells, delivering a signal that programs effector T cells to differentiate into regulatory T (Treg) cells specific for self-antigens relevant to the patient’s disease. These disease- or tissue-specific Treg cells induce immunological tolerance to block undesired immune responses to self-antigens, while maintaining normal immune surveillance and activity.

About Parvus Therapeutics Inc.
Parvus Therapeutics Inc. is a privately held biopharmaceutical company developing Navacims, a platform technology based on foundational research published in 2016 (Nature 530:434), to treat autoimmune diseases. Parvus’ mission is to shift the treatment paradigm toward Navacim-directed immune regulation, avoiding non-specific immune suppression associated with current therapies. Parvus’ innovative approach has the potential to benefit millions of patients suffering from debilitating autoimmune diseases and other chronic inflammatory conditions. Parvus is advancing a pipeline of proprietary drug candidates for multiple autoimmune indications through preclinical development and

— Hugh Young Rienhoff, Jr., M.D., appointed as Chairman of the Board

— Charles A. Johnson, M.D., appointed to Board of Directors

— Alain Delcayre, Ph.D., appointed Senior Vice President of Research

SOUTH SAN FRANCISCO, Calif. & CALGARY, Alberta — (BUSINESS WIRE) — July 16, 2019 — Parvus Therapeutics, a biopharmaceutical company focused on the development of disease-specific immunoregulatory medicines to treat autoimmune diseases without impairing normal immunity, today announced the appointment of Hugh Young Rienhoff, Jr., M.D., as Chairman of the Board, Charles A. Johnson, M.D., to the Board of Directors, and Alain Delcayre, Ph.D., as Senior Vice President of Research.

“We are delighted to announce the addition of Hugh, Charlie, and Alain to the Parvus team as we continue to expand and build out our R&D organization and Board of Directors following the close of our second license and collaboration agreement,” said Curtis Ruegg, Ph.D., President & CEO of Parvus. “Hugh’s leadership and experience as a successful entrepreneur and venture capitalist is an ideal fit with Parvus as we set and implement the Company’s direction and strategy. Together with Charlie’s strong background in biopharma in clinical development and overall product development strategies, these two board additions enrich Parvus with valuable guidance as we invest more resources toward the selection of additional Navacim drug candidates for development. With the addition of Alain as SVP of Research, we are further positioned to successfully execute on our expanding R&D plan.”

Dr. Rienhoff is a San Francisco Bay area physician and entrepreneur and the founder and CEO of Imago Biosciences, his fourth start-up. Prior to Imago, he was the founder and CEO of FerroKin BioSciences, which was acquired by Shire Plc in 2012. Earlier in his career, Dr. Rienhoff was involved in venture capital as a Director at Abingworth Management in London and a partner at New Enterprise Associates (NEA). Throughout his career, Dr. Rienhoff has held numerous board positions in life science companies, many of which lead to successful exits. He obtained his B.A. from Williams College, studied mathematics at Harvard University and earned an M.D. from the Johns Hopkins University School of Medicine. He trained in internal medicine as a member of the Osler Medical House staff at the Johns Hopkins Hospital where he was later a fellow in hematology and clinical genetics. Dr. Rienhoff continued his training at the Fred Hutchinson Cancer Research Center in Seattle, Washington as a Howard Hughes Investigator.

“I am delighted to assume the position of Chairman at Parvus as the company transitions to the clinical stage with products of such great promise,” said Dr. Rienhoff.

Dr. Johnson is an accomplished physician and pharmaceutical executive with more than 40 years of experience in clinical practice and biopharmaceutical clinical development. Most recently, he was the Chief Medical Officer of Neurotech, where he was responsible for all clinical programs using encapsulated cell technology to treat retinal diseases. Before Neurotech, he was the Vice President of Global Medical Affairs at Vertex and held leadership positions at Inspire Pharmaceuticals and APT Pharmaceuticals. Dr. Johnson began his biotechnology career at Genentech where he was the Vice President and Head of the Immunology and Tissue Repair clinical group. At Genentech, he was the Chair of the Development Review Committee where he led the team responsible for reviewing and assessing pipeline candidates. Dr. Johnson received his M.D. from the University of Cape Town in South Africa, attained Board Certification in Pediatrics at the Red Cross War Memorial Children’s Hospital, and completed his Pediatric Pulmonology Fellowship at Washington University.

Dr. Delcayre is a seasoned biotechnology professional with considerable experience translating early stage research into clinical drug candidates, primarily in the field of nanoparticle-based immunotherapy. He has consulted on and co-founded several start-ups/entities focused on the commercialization of exosome-based therapeutics. Notably, while VP of Research and Development at Anosys, Dr. Delcayre and his team co-discovered Exosome Display, a technique to manipulate exosome protein content that is now broadly implemented by many companies in exosome-based targeted drug delivery. Dr. Delcayre received his Ph.D. in Molecular and Cellular Biology at the Université Pierre et Marie Curie (PARIS VI) and completed postdoctoral studies at the California Institute of Biological Research and Stratagene (La Jolla, CA).

About Parvus Therapeutics Inc.

Parvus Therapeutics Inc. is a privately-held biopharmaceutical company engaged in the development and commercialization of Navacim therapeutics targeting autoimmune and other inflammatory diseases. Navacims were discovered by Pere Santamaria, M.D., Ph.D., Chief Scientific Officer and Founder of Parvus, Julia McFarlane/Diabetes Canada Professor of the Cumming School of Medicine at the University of Calgary.

Contacts

Burns McClellan
Ryo Imai / Robert Flamm
212-213-0006 x315 / 212-213-0006 x364
rimai@burnsmc.com / rflamm@burnsmc.com

Source: Parvus Therapeutics  

Research underpins part of the recently executed license and collaboration agreement to develop, manufacture and commercialize Navacimtherapeutics for treatment of gastrointestinal inflammatory diseases, including autoimmune liver disease

Article published in Nature Communications

BURLINGAME, Calif. & CALGARY, Alberta — June 26, 2019 — (BUSINESS WIRE) Parvus Therapeutics, a biopharmaceutical company focused on the development of disease-specific immunoregulatory medicines to treat autoimmune diseases without impairing normal immunity, today announced publication of preclinical proof-of-concept research demonstrating that Navacim therapeutics induce immune tolerance to specific autoantigens resulting in disease reversal while maintaining normal immune system function in multiple preclinical models of autoimmune liver disease (ALD). The findings from this research underpin part of the recently announced license and collaboration agreement to develop Navacim therapeutics for gastrointestinal inflammatory diseases, including autoimmune liver diseases (ALD). The article was published in Nature Communications (https://doi.org/10.1038/s41467-019-09893-5).

“Although current treatments for chronic inflammatory diseases, such as IBD, ALD, and rheumatoid arthritis, offer significant therapeutic benefits to patients, their generalized immune suppressive activity can result in a range of potentially serious side effects, including infection and possibly malignancy,” said Pere Santamaria, M.D., Ph.D., founder and chief scientific officer of Parvus, and senior author of the paper. “Parvus was founded to leverage the discovery of Navacims to develop a better approach to treating these diseases. This study demonstrates that our Navacim platform technology can generate a precision therapeutic outcome in several validated animal models for ALD and, thus, has the potential to do the same in humans.”

The article, entitled “Suppression of a Broad Spectrum of Liver Autoimmune Pathologies by Single Peptide-MHC-Based Nanomedicines,” investigated the ability of Navacim therapeutics (a peptide-major histocompatibility complex class II-based nanomedicine) that displayed tissue-specific autoantigenic peptides associated with primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC) or autoimmune hepatitis (AIH) to reprogram CD4+ T cells into disease-suppressing type 1 regulatory T (TR1) cells in animal models. The investigators found that administration of the Navacim therapeutic was able to blunt PBC, PSC and AIH, without suppressing general immunity or local immunity against infection or metastatic tumors. Therapeutic activity was associated with TR1 recruitment to the site of the disease, the liver, as well as suppression of other pro-inflammatory processes in the liver. The authors concluded that from a translational standpoint, this study identified disease-modifying compounds for several complex liver autoimmune diseases that represent unmet medical needs.

“Our objective is to leverage our Navacim technology to develop highly innovative, well-tolerated, disease modifying treatments for a broad range of autoimmune diseases,” said Curtis Ruegg, Ph.D., President and CEO of Parvus. “This important research provides further in vivoproof-of-concept results that we are able to induce immune tolerance to a specific autoantigen while leaving normal immune system function intact. Our conviction in the potential of our Navacim technology is affirmed by our partnerships with two top-tier biopharmaceutical companies to develop Navacim therapeutics for several autoimmune and inflammatory diseases including ALD.”

About Navacims™

Navacims are a precision medicine platform designed to trigger a naturally occurring immunoregulatory mechanism of the mammalian immune system which has evolved to protect against autoimmune disease. As selected for each disease, Navacims present a singular, peptide-major histocompatibility complex (pMHC) at supra-physiological density, targeting cognate T cell receptors (TCR) on disease relevant T cells. Navacim binding causes a sustained assembly of TCR microclusters and prolonged signaling leading to disease-specific type 1 regulatory T (TR1) cell differentiation. Because Navacim activity depends on the presence of disease-causing, autoimmune T cells, their action is self-limiting. In preclinical disease models, Navacims have demonstrated broad therapeutic activity and disease reversal across a range of autoimmune disorders including diabetes, multiple sclerosis, ALD and IBD while consistently preserving immunocompetence to resist viral, microbial, and tumor challenges.

About Parvus Therapeutics Inc.

Parvus Therapeutics Inc. is a privately-held biopharmaceutical company engaged in the development and commercialization of Navacim therapeutics targeting autoimmune diseases. Navacims were discovered by Pere Santamaria, M.D., Ph.D., Chief Scientific Officer and Founder of Parvus, Julia McFarlane/Diabetes Canada Professor of the Cumming School of Medicine at the University of Calgary.

Contacts

Media
Burns McClellan
Ryo Imai / Robert Flamm
212-213-0006 x315 / 212-213-0006 x364
rimai@burnsmc.com / rflamm@burnsmc.com

  Source: Parvus Therapeutics

Burlingame, CA – (BUSINESS WIRE) – Parvus Therapeutics, a biopharmaceutical company developing disease-modifying nanomedicines to halt or reverse autoimmune disease without causing general immune suppression, announced today the appointment of Curtis Ruegg, Ph.D., as Chief Executive Officer and a member of the Company’s Board of Directors. Dr. Ruegg brings to Parvus over 25 years of leadership experience in the biopharmaceutical industry.

“Curtis possesses an industry-leading track record in advancing successful R&D programs through clinical development, launch and commercialization,” stated Janice M. LeCocq, Parvus’ Chairman of the Board. “During his career, Curtis has spearheaded programs that have advanced multiple novel biotherapeutic products from research through IND-enabling and clinical development, resulting in outcomes including the expedited FDA review and approval of a drug/device combination therapeutic for an orphan disease and commercialization of novel immune-oncology therapeutics. His experience will be invaluable as Parvus progresses its novel Navacims™ into clinical testing to meet compelling patient needs across diverse therapeutic indications in autoimmune disease.”

Pere Santamaria, Ph.D., MD., Founder & Chief Scientific Officer of Parvus, stated, “Parvus’ Navacim programs represent a transformative approach to treating disease, employing a mechanism that reprograms disease-causing immune cells to suppress autoimmunity without affecting normal functions of the immune system. Based on broad validation across preclinical in vivo models of a variety of autoimmune diseases, Parvus is poised to progress its lead efforts toward the clinic, including in our partnered program with Novartis. We are very pleased that Curtis, with his exceptional experience advancing novel therapies, will take the helm of the Company at this critical time.”

Dr. Ruegg commented, “I am thrilled to work with Parvus’ accomplished team, Board members, and advisors to launch the next chapter for the Company as our Navacims move through formal preclinical development and toward the clinic. Our Navacim programs are advancing on plan, including internal development candidates targeting autoimmune liver disease and inflammatory bowel disease, as well as our lead program in Type 1 diabetes in collaboration with Novartis. Our goal at Parvus is to leverage the power of our immunoregulatory technology to produce breakthrough nanomedicines that will usher in a new treatment paradigm for patients suffering from autoimmune diseases who are underserved by current approaches.”

Prior to joining Parvus, Dr. Ruegg held leadership positions at Revance, including as Executive Vice President, Technical Operations. During his tenure, he established and managed the biologics development program and supply chain to support the company’s lead candidate, DaxibotulinumtoxinA for Injection (RT002), from IND through Phase 3 development. Previously, he was Senior Vice President, Technical Operations at Cotherix, where he was instrumental in the NDA filing and expedited FDA review and approval for VENTAVIS® (iloprost), a drug/pulmonary delivery device combination therapeutic for pulmonary arterial hypertension. Dr. Ruegg also served in the leadership roles of Vice President, Preclinical and Process Development at InterMune (acquired by Roche), and Vice President, Research and Development at AP Cells. He began his career at Dendreon playing a key role in the development of Provenge® (sipuleucel-T). Dr. Ruegg received his Ph.D. degree from Johns Hopkins University School of Medicine pursuing research on retroviral-mediated immunosuppression. He was a Cancer Research Institute Fellow at Stanford University School of Medicine working on novel immune cell surface receptors for therapeutic development under Dr. Edgar Engleman in the Department of Pathology and Stanford Medical Center Blood Center.

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.

Contacts
For Parvus Therapeutics
Justin Jackson, 212-213-0006, ext. 327
jjackson@burnsmc.com

Source: Parvus Therapeutics Inc.

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.”

About T1D
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.

Contacts
For Parvus Therapeutics
Justin Jackson, 212-213-0006, ext. 327
jjackson@burnsmc.com

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.

About Navacims™
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.

Contacts
Parvus Therapeutics
Janice M. LeCocq, 850-724-0532
Chief Executive Officer