Parvus Therapeutics, a biopharmaceutical company developing Navacim™ platform-based disease-specific immunoregulator therapeutics to treat autoimmune diseases by activating endogenous generation of disease-specific regulatory T cells (Tregs) without impairing normal immune system function, today announced an agreement with National Resilience, Inc. (Resilience), for the tech transfer, scale-up and GMP manufacturing of PVT201, Parvus’ lead NavacimTM drug candidate being developed to treat Primary Biliary Cholangitis.
“Our collaboration with Resilience, a world class partner with facilities and expertise well matched to the Navacim manufacturing process, de-risks our CMC activities and our overall IND enabling program,” stated Peter Strumph, CEO. “Recent progress by Parvus research and development includes manufacturability improvements to the Navacim platform. Now, through our partnership with Resilience for protein manufacturing, conjugation, and fill/finish services, we have the capabilities to scale the process and manufacture material suitable for clinical studies.”
Resilience, with a network of sites across North America, will work with Parvus out of its facility in Mississauga, Ontario. That biomanufacturing site currently provides process and analytical development, scale up, drug substance and drug product/fill finish manufacturing for a variety of medicines across multiple modalities.
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, visit https://parvustx.com.
Resilience is a manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions with the aim to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to offer regulatory capabilities and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience aims to free partners to focus on the discoveries that improve patients’ lives. For more information, visit www.Resilience.com.