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    Parvus Announces First Human Subject Dosed in A Clinical Trial With PVT201, A First-in-Class Off-the-Shelf Regulatory T-Cell (Treg) Inducing PMHC Nanomedicine Therapy

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    Parvus Therapeutics, a private clinical-stage biopharmaceutical company developing a pipeline of novel treatments for autoimmune disease announced the successful dosing of the first subject in a Phase 1/2, first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PVT201 single ascending doses in healthy subjects and primary biliary cholangitis patients.

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    Parvus Announces First Human Subject Dosed in A Clinical Trial With PVT201, A First-in-Class Off-the-Shelf Regulatory T-Cell (Treg) Inducing PMHC Nanomedicine Therapy

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    Parvus Therapeutics, a private clinical-stage biopharmaceutical company developing a pipeline of novel treatments for autoimmune disease announced the successful dosing of the first subject in a Phase 1/2, first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PVT201 single ascending doses in healthy subjects and primary biliary cholangitis patients.

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    Parvus Announces First Human Subject Dosed in a Clinical Trial with PVT201, a First-in-Class Off-the-Shelf Regulatory T-cell (Treg) Inducing pMHC Nanomedicine Therapy

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    Parvus Therapeutics, a private clinical-stage biopharmaceutical company developing a pipeline of novel treatments for autoimmune disease announced the successful dosing of the first subject in a Phase 1/2, first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PVT201 single ascending doses in healthy subjects and primary biliary cholangitis patients.

    Copyright:

    © All Rights Reserved
    6 views3 pages

    Parvus Announces First Human Subject Dosed in A Clinical Trial With PVT201, A First-in-Class Off-the-Shelf Regulatory T-Cell (Treg) Inducing PMHC Nanomedicine Therapy

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    PR.com
    Parvus Therapeutics, a private clinical-stage biopharmaceutical company developing a pipeline of novel treatments for autoimmune disease announced the successful dosing of the first subject in a Phase 1/2, first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PVT201 single ascending doses in healthy subjects and primary biliary cholangitis patients.

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    © All Rights Reserved
    of 3

    Parvus Announces First Human Subject Dosed in a Clinical Trial with PVT201,

    a First-in-Class Off-the-Shelf Regulatory T-cell (Treg) Inducing pMHC


    Nanomedicine Therapy

    Parvus Therapeutics, a private clinical-stage biopharmaceutical company developing a pipeline of


    novel treatments for autoimmune disease announced the successful dosing of the first subject in a
    Phase 1/2, first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and
    pharmacodynamics of PVT201 single ascending doses in healthy subjects and primary biliary
    cholangitis patients.

    South San Francisco, CA October 17, 2024 --(PR.com)-- Parvus Therapeutics, a private clinical-stage
    biopharmaceutical company developing a pipeline of novel treatments for autoimmune disease
    announced the successful dosing of the first subject in a Phase 1/2, first-in-human study to evaluate the
    safety, tolerability, pharmacokinetics, and pharmacodynamics of PVT201 single ascending doses in
    healthy subjects and primary biliary cholangitis patients.

    Primary biliary cholangitis (PBC) is a chronic, progressive autoimmune disease of the liver which causes
    inflammation of the bile ducts and is associated with fatigue and severe itching, and can progress to
    cirrhosis, liver transplant and death. 40% of PBC patients are not adequately responsive to
    ursodeoxycholic acid - the standard-of-care treatment for PBC. Current treatments for PBC do not impact
    the underlying autoimmune pathogenesis of the disease.

    PVT201 consists of multiple copies of a peptide-major histocompatibility complex (pMHC) conjugated


    covalently to an iron-dextran nanoparticle. PVT201 has shown disease modification and hepatoprotection
    in preclinical models of primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune
    hepatitis and has received FDA Orphan Drug designation for PBC. Initial clinical studies of PVT201 are
    designed to demonstrate the safety and tolerability of PVT201 and confirm biologic and clinical activity
    in humans.

    “Dosing of the first human subject with PVT201 represents a significant advance in the field of treating
    autoimmune disease via antigen-specific Treg cells,” said Dr. Pere Santamaria MD, PhD, co-founder and
    Chief Scientific Officer. “Unlike cell therapy that requires ex vivo expansion of Treg cells, PVT201
    harnesses the patient’s own immune system to trigger in vivo formation and expansion of antigen-specific
    Treg cells. In model systems, these Treg cells traffic to inflamed tissues and suppress local pathogenic
    immune responses and restore immunological tolerance and as such, hold great promise for patients
    suffering from autoimmune disease.”

    “With the dosing of the first subject in a Phase 1/2 clinical trial, Parvus has made the successful transition
    from pre-clinical to clinical company,” said Dr. Hugh Young Rienhoff Jr. MD, Chairman of the Board of
    Directors and Chief Medical Officer. “We look forward to executing our clinical plan to assess safety,
    tolerability, biologic effects, and most importantly, clinical effects of PVT201. Insights learned from the
    initial PVT201 clinical trials will inform the further development of PVT201 as well as drug candidates
    for other autoimmune conditions.”

    Page 1 of 3
    PR.com Press Release Distribution Terms
    About Parvus Therapeutics and Our pMHC Nanomedicine Technology
    At Parvus, a clinical-stage company, we are developing proprietary pMHC nanomedicine drug candidates
    designed to trigger in vivo generation of antigen-specific Treg cells with the potential to halt and cure
    autoimmune disease by restoring organ-specific immune tolerance without compromising systemic
    immunity. Each such protein nanomedicine drug candidate consists of multiple copies of a
    human-specific peptide-major histocompatibility complex conjugated covalently to an iron-dextran
    nanoparticle with the peptide and major histocompatibility complex specific for each target autoimmune
    indication. In mouse models, Parvus pMHC nanomedicines delivered intravenously generate
    antigen-specific Treg cells in vivo that then home to the target site of tissue inflammation and restore
    immune tolerance. In multiple mouse models, Parvus pMHC nanomedicines have demonstrated broad
    therapeutic activity and disease reversal across a range of autoimmune disorders. Our lead pMHC
    nanomedicine drug candidate, PVT201, is being developed for liver autoimmune disease and is currently
    being studied in a Phase 1/2 clinical trial in Australia. Our second pMHC nanomedicine drug candidate,
    PVT401, is being developed for inflammatory bowel disease by Parvus in partnership with AbbVie.
    Other pMHC nanomedicine drug candidates are in development for type 1 diabetes, multiple sclerosis,
    rheumatoid arthritis, organ transplant rejection, and celiac disease.

    Page 2 of 3
    PR.com Press Release Distribution Terms
    Contact Information:
    Parvus Therapeutics U.S., Inc.
    Jord Cowan
    1-403-708-3401
    Contact via Email
    www.parvustx.com

    Online Version of Press Release:


    https://www.pr.com/press-release/922930

    Page 3 of 3
    PR.com Press Release Distribution Terms

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