Pluri’s CDMO Selected to Manufacture Kadimastem’s Novel Cell Therapy Product Candidates
Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) has signed a tech transfer and manufacturing agreement with Kadimastem (TASE: KDST) through its PluriCDMO™ division. PluriCDMO™ will manufacture two cell therapy product candidates for Kadimastem: AstroRx® for ALS treatment and IsletRx for diabetes treatment. This collaboration leverages Pluri's 47,000 square foot GMP cell production facility and expertise in developing and manufacturing cell-based products. The agreement supports Kadimastem's preparation for clinical trials and expansion into the U.S. market, particularly for an upcoming FDA Phase 2a study of AstroRx®. This partnership highlights PluriCDMO™'s versatility and commitment to advancing innovative life-saving therapies.
- Signed manufacturing agreement with Kadimastem
- Will manufacture two cell therapy product candidates: AstroRx® for ALS and IsletRx for diabetes
- Leverages 47,000 square foot GMP cell production facility
- Supports Kadimastem's preparation for FDA Phase 2a study
- Demonstrates versatility of PluriCDMO™ platform
- None.
Insights
Pluri's announcement of a manufacturing agreement with Kadimastem is a noteworthy development in the biotechnology sector, particularly for investors interested in the progress of cell therapy treatments. The agreement to develop AstroRx® for ALS and IsletRx for diabetes is especially significant as these conditions currently have limited treatment options, hence the need for advanced therapies is high.
The collaboration with PluriCDMO™ allows Kadimastem to leverage an established GMP-grade facility, which is important for maintaining the regulatory standards required for clinical trials. This not only facilitates the immediate clinical trial phases but also positions Kadimastem well for future commercial production if the therapies prove successful.
Moreover, the choice of PluriCDMO™ underscores its reputation and capabilities in scaling cell-based product manufacturing while maintaining quality standards. This aspect could be pivotal for Kadimastem's strategy to penetrate the U.S. market, where stringent FDA regulations apply. For investors, this partnership could mean a real acceleration in clinical development timelines and potentially a faster path to market, which can be beneficial for both companies.
From a financial perspective, this agreement can be seen as a positive indicator for Pluri. The collaboration could not only bring in revenue through the manufacturing agreement but also strengthen Pluri's market position as a leading CDMO in the biotech industry. This can potentially attract more clients seeking high-quality manufacturing partners, thereby driving future revenue streams.
For Kadimastem, the partnership serves as a strategic move to mitigate manufacturing risks and costs associated with developing cell therapies. Outsourcing these tasks to an experienced CDMO allows Kadimastem to focus more on the clinical and regulatory aspects of their product development. This can be particularly advantageous in the long run as it could lead to more efficient capital allocation and operational focus.
Investors should note that while this agreement is a step forward, it is still contingent on the successful progression of clinical trials. Therefore, while the short-term financial impact might be limited, the long-term benefits could be substantial if the therapies gain approval and move towards commercialization.
PluriCDMO™, the Company’s contract development and manufacturing organization, recognized as a leading manufacturing partner offering scalability and mass scale production to a growing number of innovative life science companies
HAIFA, Israel, July 18, 2024 (GLOBE NEWSWIRE) -- Leading biotechnology company Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) ("Pluri" or the "Company"), which transforms cells into solutions that promote global wellbeing and sustainability, today announced it has signed a tech transfer and manufacturing agreement with Kadimastem Ltd. (TASE: KDST), a clinical stage biotechnology company developing therapeutic cells for ALS and diabetes treatments. PluriCDMO™, launched earlier this year, leverages Pluri’s 47,000 square foot good manufacturing practice (GMP) cell production facility to manufacture cell-based products for life science companies.
PluriCDMO™ will manufacture two cell therapy product candidates for Kadimastem: AstroRx®, clinical grade human astrocytes (nervous system supporting cells) for the treatment of ALS for an upcoming U.S. Food and Drug Administration (FDA) Phase 2a study; and IsletRx, clinical grade pancreatic islet cells which produce and secrete insulin and glucagon in response to blood glucose levels, for the treatment of diabetes.
Key to Kadimastem’s selection of PluriCDMO™ is Pluri’s unparalleled expertise and experience in developing and manufacturing cell-based products in GMP grade for clinical use. From initial clinical trial batches to mass scale commercial production, PluriCDMO™ is a long-term partner and service provider for the cell therapy production needs of the most innovative companies.
"Working with Pluri marks a pivotal milestone, enhancing Kadimastem's capacity to manufacture our products under GMP conditions,” stated Ronen Twito, Executive Chairman & President of Kadimastem. “This collaboration is integral to our strategy as we prepare for clinical trials and expand into the U.S. market with our AstroRx® product candidate."
“We are excited to work with Kadimastem and support their development of cell therapies, potentially improving the lives of patients with ALS and diabetes,” stated Yaky Yanay, Chief Executive Officer and President of Pluri. “This collaboration underscores the versatility of our PluriCDMO™ platform and our commitment to aiding innovative companies in advancing their life-saving therapies. We look forward to a successful collaboration with Kadimastem as they make progress with their clinical development programs.”
About Pluri Inc.
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 well-being 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 challenges— 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, foodtech and agtech. The Company also offers CDMO services. Pluri establishes partnerships that leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
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 https://pluri-biotech.com/transforming-cell-therapy/ or contact CDMO@Pluri-biotech.com
About Kadimastem Ltd.
Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, healthy and functional human astrocytes, is the company's lead product in clinical development for the treatment for ALS and in pre-clinical development stage for other neurodegenerative indications.
IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).
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 the expected manufacturing of cell therapy product candidates for Kadimastem and that the collaboration underscores the versatility of its platform. 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.
Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Jessica Daitch at Jessica@quantum-corp.com
FAQ
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