Full Press Release Details
HAIFA, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) ("Pluri" or "the Company"), a leading biotechnology company that transforms cells into solutions, today announced that its CDMO division (PluriCDMO™) has signed a manufacturing agreement with Remedy Cell Ltd, an innovative, biopharmaceutical company developing stem cell-derived, cell-free therapeutics for complex fibrotic conditions.
PluriCDMO™ will support Remedy Cell’s production team in the manufacturing of a clinical-grade Working Cell Bank (WCB) and GMP batches of Remedy Cell’s drug candidate RC-0315, derived from mesenchymal stem cells, towards the launch of their Phase Ib clinical trial for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a lethal, complex, progressive interstitial lung disorder with a median survival of 3.8 years.
Remedy Cell CEO, Ayelet Dilion-Mashiah, said, “This is an exciting time at Remedy Cell as we initiate the early stages of clinical development of our novel drug candidate, RC-0315, for IPF, a condition with significant unmet treatment needs. We look forward to the manufacture of our drug candidate at Pluri’s GMP facilities and believe that their vast experience developing and manufacturing cell therapies will accelerate our time to market.”
Pluri CEO and President, Yaky Yanay, said, ”Remedy Cell is an innovative company developing crucial treatments like RC-0315 to address complex conditions with limited therapeutic options. We are delighted that Remedy Cell has chosen PluriCDMO™ to assist with their clinical manufacturing, and we eagerly anticipate the establishment of a robust, long-term partnership grounded in excellence and collaboration."
Pluri launched its CDMO division in January 2024, leveraging its proprietary knowledge, cutting-edge technology and cell therapy production facility on behalf of clients. PluriCDMO™ clients gain access to Pluri's state-of-the-art GMP facilities, and to Pluri's patented bioreactor system, which enables 3D cell expansion at mass scale via a fully controlled, automated and validated process. For more information visit www.pluri-biotech.com/cdmo or contact CDMO@Pluri-biotech.com
Remedy Cell Ltd., a biopharmaceutical company, harnesses scientific advancements in cell-derived therapies to develop first-in-class, breakthrough treatments for patients suffering from complex fibrotic diseases. The company’s lead product RC-0315 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) has accomplished very encouraging pre-clinical results and it aims to reach first in human in early 2025. IPF is a serious chronic disease that affects the tissue surrounding the air sacs, or alveoli, in the lungs. IPF is an Orphan Disease that affects 100,000 patients in the US and approximately 110,000 patients in Europe. There is currently no cure and IPF patients are not likely to survive beyond 2-5 years from diagnosis. There is an urgent need for a therapeutic treatment option that effectively degrades fibrosis and restores lung function.
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses that it anticipates the establishment of a robust, long-term partnership grounded in excellence and collaboration with Remedy Cell. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri's reports filed from time to time with the Securities and Exchange Commission.