The collaboration will combine AbbVie’s expertise in Immunology with Parvus’ innovative Navacim™ regulatory T cells (Treg) immune tolerization platform technology to develop therapies for Inflammatory Bowel Disease

SOUTH SAN FRANCISCO, CA, March 20, 2024 — Parvus Therapeutics announced today that it has entered into an exclusive worldwide license collaboration and option agreement with AbbVie Inc. (NYSE: ABBV) for the development and commercialization of novel treatments for Inflammatory Bowel Disease (IBD), utilizing Parvus’ Navacim™ Treg immune tolerization platform technology. Navacims™ present multivalent peptide major histocompatibility complexes (peptide-MHCs) to T cells, triggering the endogenous expansion and differentiation of the T cells into antigen-specific Tregs. This approach is being evaluated as a potential to halt or cure autoimmune disease by restoring organ-specific immune tolerance without compromising normal immunity.

“We are excited to collaborate with AbbVie, an industry leader with global development and commercialization expertise, to advance our shared mission of transforming patient care through scientific innovation,” said Peter Strumph CEO of Parvus. “This agreement represents a significant validation of our Navacim technology as a Treg immune tolerization platform capable of generating novel development candidates for autoimmune disease.”

Under the terms of the agreement, AbbVie receives an exclusive worldwide option to develop and commercialize Navacim therapies for IBD resulting from the collaboration. Parvus will receive an upfront payment and a potential equity investment and is eligible to receive downstream development and commercial milestone payments and royalties on net sales of products.

About Parvus
Parvus is a preclinical-stage private company developing the proprietary novel Navacim™ platform technology with the potential to halt and cure autoimmune disease. Navacims present multivalent peptide-MHCs to T cells which triggers the endogenous expansion and differentiation of the T cells into antigen-specific regulatory T cells (Tregs) which provide potentially curative organ-specific immune tolerance without compromising normal immunity to infections and cancer. Parvus’ lead Navacim (PVT201) has shown disease modification and hepatoprotection in preclinical models of Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, and Autoimmune Hepatitis. Parvus’ pipeline includes Navacim development programs for IBD, Type-1 Diabetes, Multiple Sclerosis, Rheumatoid Arthritis, transplant rejection prevention, and Celiac Disease. For more information, please visit www.parvustx.com.

Parvus Therapeutics announced today the publication of data showing that peptide-MHC class II-coated nanoparticles (Navacims) operate by triggering the expansion of cognate T follicular helper (TFH) cells.

SOUTH SAN FRANCISCO, CALIFORNIA— May 9, 2023 — Parvus Therapeutics, a biopharmaceutical company developing the proprietary Navacim™ platform technology which triggers endogenous generation of regulatory T cells (Tregs) to provide organ specific immunoregulation without impairing normal immune function, announced today the publication of data showing: (i) that peptide-MHC class II-coated nanoparticles (Navacims) operate by triggering the expansion of cognate T follicular helper (TFH) cells and their immediate transdifferentiation into autoimmune disease-suppressing T regulatory type 1 (TR1) cells in vivo; and (ii) that BLIMP 1 is a gatekeeper for this novel cellular reprogramming event.

The data which identifies progenitor cells and describes the reprogramming sequence were published in an article published in the journal Cellular& Molecular Immunology: Solé et al. (2023), A T follicular helper cell origin for T regulatory type 1 cells. Cellular and Molecular Immunology. View

“The data described in this manuscript enhance our understanding of why and how Navacims re-program autoreactive T cells to comprehensively suppress organ-specific autoimmunity,” said Dr Pere Santamaria, the senior author of this publication and Parvus founder and chief scientific officer.

About the Parvus Navacim Platform
Navacims present a high-density array of peptide-MHCII complexes to cognate T cell receptors on autoimmune disease-relevant, autoantigen-experienced T cells, leading to the formation and expansion of cognate autoimmune disease-suppressing T-regulatory type 1 (TR1) cells in vivo. The resulting TR1 Treg cells specifically suppress autoimmune attacks in diseased organs through direct and bystander immunoregulation.

About Parvus
Parvus is a preclinical-stage private company developing the proprietary novel Navacim™ platform technology with the potential to halt and cure autoimmune disease. Navacims trigger endogenous generation of antigen-specific regulatory T cells (Tregs) which provide organ specific immune tolerance without compromising normal immunity to infections and cancer. Our lead Navacim (PVT201) has shown disease modification and hepatoprotection in preclinical models of Primary biliary cholangitis, Primary sclerosing cholangitis, Autoimmune hepatitis and Nonalcoholic steatohepatitis. Our pipeline includes Navacim development programs for Inflammatory bowel disease, Type-1 diabetes, Multiple sclerosis and Celiac Disease.

For more information contact

Jord Cowan
Vice President of Operations
Parvus Therapeutics Inc.
(403) 708-3401
jcowan@parvustx.com
www.parvustx.com

SOUTH SAN FRANCISCO, CALIFORNIA— November 29, 2021 — Parvus Therapeutics, a biopharmaceutical company developing Navacim™ platform-based disease-specific immunoregulator therapeutics to treat autoimmune diseases by activating endogenous generation of disease-specific regulatory T cells (Tregs) without impairing normal immune system function, today announced an agreement with National Resilience, Inc. (Resilience), for the tech transfer, scale-up and GMP manufacturing of PVT201, Parvus’ lead Navacim™ drug candidate being developed to treat Primary Biliary Cholangitis.

“Our collaboration with Resilience, a world class partner with facilities and expertise well matched to the Navacim manufacturing process, de-risks our CMC activities and our overall IND enabling program,” stated Peter Strumph, CEO. “Recent progress by Parvus research and development includes manufacturability improvements to the Navacim platform. Now, through our partnership with Resilience for protein manufacturing, conjugation, and fill/finish services, we have the capabilities to scale the process and manufacture material suitable for clinical studies.”

Resilience, with a network of sites across North America, will work with Parvus out of its facility in Mississauga, Ontario. That biomanufacturing site currently provides process and analytical development, scale up, drug substance and drug product / fill finish manufacturing for a variety of medicines across multiple modalities.

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 re-programs effector T cells to differentiate and expand 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 Navacim™ Manufacturing
Navacims, in their final form, represent a novel nanoparticle/protein molecule with targeted pharmacologic activity. Navacims are made by combining two types of component parts, each with precedent in drug development, found in approved therapeutics, and which are manufactured using well established processes. Specifically, the two component parts of Navacims are nanoparticles made from an iron oxide-core coated with polymer and peptide-major histocompatibility complex (pMHC) proteins. The unit operations to make a Navacim (polymerizing an iron core, CHO cell expression of the pMHC protein, purification with Protein-A, room temperature conjugation of the nanoparticle with the pMHC, and standard buffered saline drug product fill) are well established and readily available in a competitive ecosystem of qualified contract manufacturers.

About Parvus Therapeutics Inc.
Parvus Therapeutics Inc. (Parvus) 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 into the clinical. Parvus’ leadership team is experienced in successful drug discovery, development, manufacturing, regulatory approval, and commercialization. For more information, visit https://parvustx.com

About Resilience
Resilience is a manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions with the aim to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to offer regulatory capabilities and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience aims to free partners to focus on the discoveries that improve patients’ lives. For more information, visit www.Resilience.com.

SOUTH SAN FRANCISCO, CALIFORNIA & CALGARY, ALBERTA — November 19, 2021 — Parvus Therapeutics is a biopharmaceutical company developing Navacim™ platform based disease-specific immunoregulating therapeutics to treat autoimmune diseases by activating endogenous generation of disease-specific regulatory T cells (Tregs) without impairing normal immune system function. Today Parvus announced it has entered into an agreement with Ardena, a specialist pharmaceutical Contract Development and Manufacturing Organization (CDMO), for process development, scale-up and GMP manufacturing of NavacimTM nanoparticles, a key building block for all of our Navacim platform drug development candidates.

Under the agreement, Ardena will manufacture polymer coated iron oxide-core nanoparticles used in Navacim production. Recent progress with Ardena includes a successful nanoparticle engineering run at a scale suitable for clinical and commercial manufacturing. Nanoparticles made at Ardena are used at Parvus to manufacture Navacims for research and development and will be used at a second supply chain manufacturing partner to manufacture Navacims for clinical studies.

“Parvus continues to make progress with the overall IND enabling development and in particular Parvus has made progress with Navacim manufacturing,” stated Peter Strumph, CEO. “The partnership with Ardena gives Parvus access to world-class process development and manufacturing expertise and a partner that has successfully manufactured Navacim nanoparticles to support Navacim platform research and development.”

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 re-programs effector T cells to differentiate and expand 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 Navacim™ Manufacturing

Navacims, in their final form, represent a novel nanoparticle/protein molecule with targeted pharmacologic activity. Navacims are made by combining two types of component parts, each with precedent in drug development, found in approved therapeutics, and which are manufactured using well established processes. Specifically, the two component parts of Navacims are nanoparticles made from an iron oxide-core coated with polymer and peptide-major histocompatibility complex (pMHC) proteins. The unit operations to make a Navacim (polymerizing an iron core, CHO cell expression of the pMHC protein, purification with Protein-A, room temperature conjugation of the nanoparticle with the pMHC, and standard buffered saline drug product fill) are well established and readily available in a competitive ecosystem of qualified contract manufacturers.

About Parvus Therapeutics Inc.

Parvus Therapeutics Inc. (Parvus) 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 into the clinical. Parvus’ leadership team is experienced in successful drug discovery, development, manufacturing, regulatory approval, and commercialization. For more information, please visit https://parvustx.com

About Ardena Group

The Ardena Group (Ardena) is a world-class Contract Development and Manufacturing Organization (CDMO). Ardena assists pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecules to the clinic and the market. Ardena provides a comprehensive range of services from early drug substance development to finished dosage form, including: drug substance development & manufacturing; solid state research; drug product development & manufacturing; drug product packaging, labelling & supply; bioanalysis; dossier development and nanomedicine. For more information, please visit https://ardena.com/

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

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