South San Francisco, CA – August 06, 2024 – Parvus Therapeutics, a private preclinical company developing a pipeline of novel Navacim™ autoimmune disease drug candidates which trigger endogenous generation of regulatory T cells (Tregs) to provide organ specific immunoregulation, is pleased to announce the appointments of Joanne B.L. Tan, PhD as the Senior Vice President of Research and Development and Sarah Grimberg as the Senior Director of Clinical Operations.
Dr. Tan’s training and experience includes a PhD in Immunology and Developmental Biology from University of Toronto and industry experience with a focus on advancing drug candidates through development and clinical proof-of-concept studies. Dr. Tan joins Parvus from Sana Biotechnology, where she held the position Head of Translational Sciences. Sarah Grimberg has experience planning and leading Phase 1 single site to Phase 3 multi-site global clinical studies for multiple development programs 3 of which have received FDA approval.
“We are thrilled to welcome Dr. Tan and Sarah Grimberg to our leadership team,” said Peter Strumph, CEO of Parvus Therapeutics. “Their proven track record leading teams in drug development, translation, regulatory submissions and clinical operations strengthen our capability to execute current and future drug development activities.”
About Parvus Therapeutics: Parvus is developing products based on the novel Navacim™ platform technology which triggers endogenous generation of antigen-specific Tregs with the potential to halt and cure autoimmune disease by restoring 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 (PBC), Primary Sclerosing Cholangitis and Autoimmune Hepatitis. PVT201 has received FDA Orphan Drug Designation for PBC and Australian HREC approval for the first-in-human study. Initial clinical studies of PVT201 are designed to demonstrate Navacim safety, tolerability and confirm biologic activity in humans. Our second Navacim (PVT401) for Inflammatory Bowel Disease is being developed by Parvus in partnership with AbbVie. We have additional Navacim development programs for Type 1 Diabetes, Multiple Sclerosis, Rheumatoid Arthritis, transplant rejection and Celiac Disease.
Parvus Therapeutics announces that PVT201 has received Orphan Drug Designation for Primary Biliary Cholangitis and Australian Human Research Ethics Committee approval to begin clinical testingSOUTH SAN FRANCISCO, CALIFORNIA — July 29, 2024 — Parvus Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PVT201 for the treatment of Primary Biliary Cholangitis (PBC) and PVT201 has obtained Australian Human Research Ethics Committee (HREC) approval to initiate a first-in-human Phase I clinical trial.
“Orphan Drug Designation and HREC approval are the latest development milestones which represent significant progress and de-risking of our plans for a first-in-human clinical study start later in 2024,” said Peter Strumph, CEO of Parvus Therapeutics. “Continued product development progress brings us closer to fulfilling our mission to cure autoimmune disease.”
Parvus is developing products based on the novel Navacim™ platform technology which triggers endogenous generation of antigen-specific regulatory T cells (Tregs) with the potential to halt and cure autoimmune disease by restoring 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 (PBC), Primary Sclerosing Cholangitis (PSC), and Autoimmune Hepatitis (AIH). Parvus’ second Navacim (PVT401) for Inflammatory bowel disease (IBD) is being developed by Parvus in partnership with AbbVie. Parvus has additional Navacim development programs for Type 1 Diabetes, Multiple Sclerosis, Rheumatoid Arthritis, transplant rejection, and Celiac Disease.
FDA Orphan Drug Designation is granted to investigational drugs addressing rare medical diseases that affect fewer than 200,000 people in the United States and, for preclinical drugs, show compelling mechanistic and disease model data that demonstrate promise to treat the disease. Orphan drug status provides benefits to drug developers, including tax credits, exemptions from certain FDA fees and post-approval marketing exclusivity.
For more information contact
Jord Cowan
Vice President of Operations
Parvus Therapeutics Inc.
(403) 708-3401
jcowan@parvustx.com
www.parvustx.com
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.
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