- Lonza to support cGMP manufacturing of RION's Purified Exosome Product (PEP), a platelet-derived exosome-based drug candidate for chronic wound care and tissue regeneration
- Collaboration leverages RION's proprietary biomanufacturing process to propel RION's industry-leading clinical development pipeline towards late-phase trials and commercialization for multiple regenerative medical conditions
RION, a commercial and clinical-stage regenerative medicine company pioneering platelet-derived exosomes for both human and animal health applications, has announced a collaboration with Lonza, one of the world's largest contract development and manufacturing organizations (CDMOs), to provide cGMP manufacturing and technical support for commercial scale production of its Purified Exosome Product (PEP) drug substance for late phase clinical supply and beyond.
RION developed a proprietary biomanufacturing platform enabling scaled production of platelet-derived exosomes. This platform allows for the advancement of RION's pipeline of exosome-based therapeutics across multiple indications. Under the terms of the agreement, Lonza will manufacture PEP drug substance at its manufacturing facility in Houston (US). RION will leverage Lonza's world-leading, state-of-the-art extracellular vesicles expertise and capabilities to operationalize its process at scale.
PEP is an exosome-based therapeutic platform candidate with immunomodulatory, anti-inflammatory and tissue regenerative properties, formulated as a shelf-stable lyophilized powder. Stabilized regenerative exosomes promote tissue repair and can be administered through multiple routes, enabling use across a broad set of indications. RION is advancing clinical programs in advanced tissue regeneration, immune-mediated dermatology diseases, musculoskeletal disease, pulmonary disease, cardiovascular health and women's health.
Atta Behfar, Cofounder and CEO, RION, said: This collaboration with Lonza ensures that our proprietary exosome manufacturing platform can be scaled to meet clinical and future commercial demand. RION's breakthrough in exosome biomanufacturing now paired with Lonza's global infrastructure allows us to bring this biologics-based innovation to patients rapidly and reliably, while staying true to our mission of affordable access.
Davide Zocco, Commercial Development Head for Exosomes and mRNA Technologies, Specialized Modalities, Lonza, added: "We are pleased to support RION's groundbreaking work in exosome-based therapies. Through our world-leading capabilities in exosome development, characterization, and manufacturing, we enable our customers to progress their innovative therapies efficiently and reliably. Through our collaboration with RION, we will apply our expertise to support the manufacture of PEP drug substance, aiming to help accelerate the availability of innovative treatments to patients worldwide."
Additional Information
To learn more about Lonza's Exosome offering, visit Lonza Exosomes
About RION
RION is a clinical-stage regenerative medicine company founded out of the Mayo Clinic after two decades of exosome research and innovation. Based in Rochester, Minnesota, the company is a global leader in isolating and mass-producing platelet-derived regenerative exosomes into a proprietary therapeutic platform to produce Purified Exosome Product (PEP), a shelf-stable biologic designed to activate the body's natural healing processes. RION is advancing an ambitious pipeline with clinical and preclinical programs in diabetic foot ulcers, knee osteoarthritis, musculoskeletal injury, dermatologic conditions, pulmonary disease, cardiovascular health, and women's health. RION's regenerative PEP technology will be integral to the therapeutic exosome revolution.
About PEP
RION's Purified Exosome Product (PEP) is a shelf stable product in a lyophilized powder derived from human platelets that contains stabilized platelet-derived regenerative exosomes. Discovered at the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program, PEP is an exosome therapeutic that is designed to deliver biologic signals with a novel mechanism of action that promotes cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells. RION and its scientific collaborators have performed extensive research showing the potential of PEP to heal a wide array of damaged tissue. PEP is currently being evaluated in clinical and preclinical studies targeting areas where current standards of care cannot address unmet clinical needs.
Disclaimer
Certain matters discussed in this media advisory may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this media advisory.
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Contacts:
RION Contact Details
smccrea@riontx.com
Lonza Contact Details
media@lonza.com
