Parvus Therapeutics, Inc.
Clinical-stage biopharmaceutical company developing peptide–MHC (pMHC) nanomedicine candidates that induce antigen-specific regulatory T cells in vivo to restore organ-specific immune tolerance. The company advances preclinical programs into early clinical studies, manages CMC and GMP scale-up through CDMO partnerships, and structures licensing and development collaborations with large pharmaceutical partners.
Industries
N/A
Nr. of Employees
small (1-50)
Parvus Therapeutics, Inc.
Products
PVT201
A peptide–MHC (pMHC) nanomedicine candidate composed of multiple copies of a pMHC conjugated to an iron-dextran nanoparticle, developed for autoimmune liver diseases; advanced into first-in-human studies and granted FDA Orphan Drug designation for primary biliary cholangitis.
PVT401
A peptide–MHC (pMHC) nanomedicine candidate in development for inflammatory bowel disease; progressed through nonclinical pharmacology and manufacturing criteria toward IND-enabling activities under a collaboration agreement with a major pharmaceutical partner.
PVT201
A peptide–MHC (pMHC) nanomedicine candidate composed of multiple copies of a pMHC conjugated to an iron-dextran nanoparticle, developed for autoimmune liver diseases; advanced into first-in-human studies and granted FDA Orphan Drug designation for primary biliary cholangitis.
PVT401
A peptide–MHC (pMHC) nanomedicine candidate in development for inflammatory bowel disease; progressed through nonclinical pharmacology and manufacturing criteria toward IND-enabling activities under a collaboration agreement with a major pharmaceutical partner.
Services
Conduct of nonclinical pharmacology, safety and mechanism-of-action studies to support regulatory filings.
Technology transfer and scale-up of nanoparticle and pMHC protein production with contract manufacturing partners to produce clinical and GMP material, including conjugation and fill/finish services.
Execution of early-phase clinical studies including safety, PK/PD and biomarker endpoints for nanomedicine candidates.
Conduct of nonclinical pharmacology, safety and mechanism-of-action studies to support regulatory filings.
Technology transfer and scale-up of nanoparticle and pMHC protein production with contract manufacturing partners to produce clinical and GMP material, including conjugation and fill/finish services.
Execution of early-phase clinical studies including safety, PK/PD and biomarker endpoints for nanomedicine candidates.
Expertise Areas
- Antigen-specific immunotherapy development
- In vivo regulatory T‑cell (Treg) induction and translational immunology
- Nanoparticle-based drug design and scale-up
- Preclinical in vivo disease modeling and mechanism-of-action studies
Key Technologies
- Peptide–MHC complexes
- Polymer-coated iron-oxide nanoparticles
- Nanoparticle–protein conjugation chemistry
- CHO mammalian cell expression systems
News & Updates
First-in-human Phase 1 single ascending dose (SAD) study of the lead pMHC nanomedicine showed safety, tolerability, PK consistent with models, and pharmacodynamic evidence of antigen-specific T-cell differentiation into regulatory T cells.
Development of PVT401 met predefined nonclinical pharmacology and manufacturing criteria; the partner endorsed progression to IND-enabling activities and issued a milestone payment.
First subject dosed in Phase 1/2 study evaluating safety, tolerability, PK and PD of PVT201 in healthy subjects and patients with primary biliary cholangitis.
License collaboration and option agreement with a major pharmaceutical company to develop and commercialize nanomedicine therapies for inflammatory bowel disease; terms include an upfront payment, potential equity investment, and eligibility for downstream milestone payments and royalties.
U.S. FDA granted Orphan Drug Designation for PVT201 for the treatment of primary biliary cholangitis; Australian HREC approval obtained to initiate a first-in-human trial.
Agreements with contract manufacturers for protein manufacturing, nanoparticle production, conjugation, and GMP fill/finish to support clinical supply and process scale-up.
First-in-human Phase 1 single ascending dose (SAD) study of the lead pMHC nanomedicine showed safety, tolerability, PK consistent with models, and pharmacodynamic evidence of antigen-specific T-cell differentiation into regulatory T cells.
Development of PVT401 met predefined nonclinical pharmacology and manufacturing criteria; the partner endorsed progression to IND-enabling activities and issued a milestone payment.
First subject dosed in Phase 1/2 study evaluating safety, tolerability, PK and PD of PVT201 in healthy subjects and patients with primary biliary cholangitis.
License collaboration and option agreement with a major pharmaceutical company to develop and commercialize nanomedicine therapies for inflammatory bowel disease; terms include an upfront payment, potential equity investment, and eligibility for downstream milestone payments and royalties.
U.S. FDA granted Orphan Drug Designation for PVT201 for the treatment of primary biliary cholangitis; Australian HREC approval obtained to initiate a first-in-human trial.
Agreements with contract manufacturers for protein manufacturing, nanoparticle production, conjugation, and GMP fill/finish to support clinical supply and process scale-up.