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Parvus Therapeutics and Ardena Enter Agreement For Tech Transfer, Scale-Up and GMP Manufacturing of Navacim Nanoparticles
Parvus Therapeutics and Ardena Enter Agreement For Tech Transfer, Scale-Up and GMP Manufacturing of Navacim Nanoparticles
Parvus Therapeutics and Ardena Enter Agreement For Tech Transfer, Scale-Up and GMP Manufacturing of Navacim Nanoparticles
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.
South San Francisco, CA November 19, 2021 --(PR.com)-- 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 Navacim™
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.
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
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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.
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/.
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Contact Information:
Parvus Therapeutics U.S., Inc.
Peter M. Strumph
415-805-8251
Contact via Email
parvustx.com
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