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.”
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.
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.”
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.
Contact
Parvus Therapeutics U.S., Inc.
Jord Cowan
1-403-708-3401
www.parvustx.com
Jord Cowan
1-403-708-3401
www.parvustx.com
Contact
Categories