Parvus Therapeutics and Ardena Enter Agreement for Tech Transfer, Scale-Up and GMP Manufacturing of Navacim Nanoparticles
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.”
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/