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Pluri Selected as CDMO by Remedy Cell for Cell-Derived Cell-Free Drug Manufacturing

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Pluri Inc. announces a manufacturing agreement between PluriCDMO™ and Remedy Cell Ltd for the production of the drug candidate RC-0315 to treat Idiopathic Pulmonary Fibrosis. The agreement aims to support Remedy Cell in manufacturing a clinical-grade Working Cell Bank and GMP batches for their Phase Ib clinical trial. Remedy Cell's CEO expresses excitement for the partnership, emphasizing the need for innovative treatments in complex conditions like IPF.
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The manufacturing agreement between Pluri Inc.'s PluriCDMO™ and Remedy Cell Ltd. is a strategic collaboration that could significantly expedite Remedy Cell's entry into clinical trials for their novel drug candidate, RC-0315. The partnership leverages PluriCDMO™'s expertise in developing and manufacturing cell therapies, potentially reducing time to market for treatments targeting Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition with a high unmet medical need and a relatively small number of effective treatments, which means that successful development and subsequent approval of RC-0315 could capture a significant market share and provide a new revenue stream for both companies.

From a biotech industry perspective, collaborations like these are essential for smaller biopharmaceutical companies that may lack the necessary infrastructure to produce clinical-grade materials. The involvement of a CDMO with a track record in cell therapy manufacturing is a positive indicator for investors, as it can mitigate some of the risks associated with the scale-up and quality control of novel therapeutics.

RC-0315, derived from mesenchymal stem cells, represents a cutting-edge approach in the treatment of IPF, a disease characterized by scarring of lung tissue that leads to progressive loss of lung function. The median survival of 3.8 years post-diagnosis underscores the urgency for new therapies. The success of this drug candidate in clinical trials could not only extend the lives of patients but also reduce the long-term healthcare costs associated with managing chronic lung diseases.

Moreover, the creation of a Working Cell Bank (WCB) as part of the GMP (Good Manufacturing Practice) process is an important step in ensuring the consistency and quality of the drug substance. This is particularly relevant in the field of cell therapies, where the complexity of biological products requires stringent manufacturing controls. The outcome of the Phase Ib clinical trial will be critical in determining the efficacy and safety profile of RC-0315, which will have direct implications for its market potential and the stock performance of both Pluri Inc. and Remedy Cell Ltd.

Idiopathic Pulmonary Fibrosis is a niche but growing segment within the pulmonary market, with a global market size that's expected to increase due to the aging population and rising incidence rates. The partnership between PluriCDMO™ and Remedy Cell could position both companies favorably within this segment. A successful Phase Ib trial could attract significant investor attention, given the rarity of breakthroughs in this area.

From a market perspective, the demand for advanced treatments for IPF provides a substantial opportunity for growth. The rarity of the condition also means that treatments can command a premium price, often supported by orphan drug designations that provide extended market exclusivity and tax advantages. Investors will be monitoring the progress of RC-0315 closely, as positive trial results could lead to a revaluation of both companies' stocks, while any setbacks could have the opposite effect.

PluriCDMO™ will support Remedy Cell in the manufacture of RC-0315 product candidate for the treatment of Idiopathic Pulmonary Fibrosis (IPF)

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."

About Pluri

Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives—from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, food-tech and agtech and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective, mass cell production. Pluri also offers CDMO services. To learn more, visit us at http://www.pluri-biotech.com or follow us on LinkedIn and X.

About PluriCDMO

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

About Remedy Cell

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.

Media Contacts

Investors: investor.relations@pluri-biotech.com / Jennifer Zimmons at Jen@quantum-corp.com

Israel Media: Shachar Yental at Shacharye@gitam.co.il

U.S. Media: Madeline Weirman at Maddie@quantum-corp.com / Jessica Daitch at Jessica@quantum-corp.com


FAQ

What is the purpose of the manufacturing agreement between PluriCDMO™ and Remedy Cell Ltd?

The agreement aims to support Remedy Cell in manufacturing a clinical-grade Working Cell Bank and GMP batches for their drug candidate RC-0315 for the treatment of Idiopathic Pulmonary Fibrosis.

What is the drug candidate being manufactured by PluriCDMO™ for Remedy Cell Ltd?

PluriCDMO™ will manufacture the drug candidate RC-0315 derived from mesenchymal stem cells for Remedy Cell Ltd.

What condition is the drug candidate RC-0315 targeting?

RC-0315 is targeting Idiopathic Pulmonary Fibrosis (IPF), a lethal, complex, progressive interstitial lung disorder with a median survival of 3.8 years.

Who is the CEO of Remedy Cell Ltd and what are their thoughts on the partnership?

The CEO of Remedy Cell Ltd is Ayelet Dilion-Mashiah, who expressed excitement about the partnership and the development of the novel drug candidate RC-0315 for IPF.

What is Pluri CEO Yaky Yanay's perspective on the partnership with Remedy Cell Ltd?

Pluri CEO Yaky Yanay believes that Remedy Cell's focus on developing crucial treatments for complex conditions aligns with Pluri's expertise in cell therapy manufacturing, aiming to accelerate time to market for RC-0315.

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About PLUR

pluristem therapeutics inc. (nasdaqcm: psti, tase: psti/pltr) is a clinical-stage biotherapy company using placental cells and a unique, proprietary, three-dimensional (3d) technology platform to develop cell therapies for conditions such as inflammation, ischemia, hematological disorders, or exposure to radiation. pluristem’s placental expanded (plx) cells are placenta-derived, mesenchymal-like adherent stromal cells that are designed to be administered to patients without the need for tissue or genetic matching. these cells release soluble biomolecules, such as cytokines, chemokines and growth factors, which act in a paracrine or endocrine manner to facilitate healing of damaged tissues by stimulating the body’s own regenerative mechanisms. the company’s proprietary, 3d expansion technology can be used to grow plx cells in mass quantities with batch-to-batch consistency at pluristem’s fda, ema and pmda-approved, state-of-the art manufacturing facility. pluristem’s first product candi