RionTM has created PEPTM (Purified Exosome ProductTM), the world’s first truly off-the-shelf allogeneic regenerative medicine platform based on the innate ability of platelets to orchestrate tissue healing. PEP is an exosome therapeutic that is designed to promote cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells. PEP has shown benefit in an array of tissues, including heart, muscle, skin, tendon, lung, and nerve and serves as the foundation of all therapeutic programs at Rion.
Rion’s PEP consists of exosomes made from platelets, which are engineered and purified through Rion’s proprietary manufacturing process. Rion has overcome the limitations of other cell- and exosome-based medicines by manufacturing an allogeneic, pure, highly reproducible, and shelf-stable exosome therapeutic that demonstrates significant tissue repair capabilities. This enables PEP to be administered easily in a wider range of clinical settings, including those that are acute, with the goal of helping any patient in need, anywhere in the world.
Pure and Scalable. Rion’s scalable manufacturing process produces a dry product with high purity and lot-to-lot consistency.
Potent and Bioactive. Rion’s manufacturing process preserves exosomes in their native state, yielding a potent, bioactive product.
Stable and Truly Off-the-Shelf. By preserving exosome structure and bioactivity, PEP has long-term shelf stability at room temperature and remains active at body temperature, allowing sustained release applications.
Rion’s proprietary manufacturing process utilizes isolation methods that minimize mechanical strain to yield a uniform population of exosomes in their native state with an intact lipid bilayer shell. The lipid bilayer is important to protect exosome bioactivity as well as biodistribution and cellular uptake in target tissues. Other processes rely on techniques that destroy the protective lipid bilayer and compromise the activity of the proteins and nucleic acids contained inside. This leads to other exosome products requiring refrigeration or subzero storage temperatures as well as exhibiting rapid degradation, whereas PEP is shelf-stable at room temperature and exhibits high potency and bioactivity at body temperature and in sustained release formulations. Rion has established scalable CGMP manufacturing for clinical trial supply of PEP.
The human body is made up of a wide array of tissues and organs working together in unison to keep us healthy and active. Cells serve as the functional building blocks for all these structures. To build new tissues and adapt to changes in their environment, cells use extracellular vesicles, including exosomes, to communicate with one another. These lipid-bound particles carry messages, including specific proteins, miRNAs, and growth factors, from one cell to another. Extracellular vesicles are commonly classified by mode of biogenesis, size, and protein contents. The cell type from which an extracellular vesicle originates determines what is inside.
Every tissue in the human body is composed of specific cell types and extracellular structures uniquely tailored to the function served by the organ or tissue. Current regenerative strategies attempt to recreate a specific cell type to regenerate the tissue of interest in a one-to-one approach. The exosomes isolated by Rion are derived from a single cell source: human platelets. As a first responder to tissue injury, platelets release exosomes possessing growth factors and signaling molecules designed to ubiquitously support tissue regeneration. Because of this, PEP provides a unique cell-free approach, bypassing the need for a cell-specific therapy and expanding the therapeutic utility of PEP to a wide array of clinical applications. PEP is cleared by the U.S. Food & Drug Administration for testing as an investigational drug in human clinical trials.See Our Pipeline