PluriCDMO™, the Company’s contract development and manufacturing organization, recognized as a leading manufacturing collaborator offering scalability and mass scale production to a growing number of innovative life science companies
HAIFA, Israel – December 9, 2024 –Pluri Inc. (Nasdaq: PLUR) (TASE:PLUR) (“Pluri” or the “Company”), a leading biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that its PluriCDMO™ business, launched earlier this year, has been shortlisted for the CDMO of the Year Award by the prestigious Advanced Therapies Awards 2025.
“This recognition is particularly meaningful as it comes less than a year after we launched our CDMO division,” stated Yaky Yanay, Chief Executive Officer and President of Pluri. “I couldn’t be prouder of what we’ve accomplished together at Pluri including signing agreements with valued clients and making strides towards our vision of supporting transformative therapies for patients worldwide. We’re excited to continue expanding our CDMO work and contributing to this dynamic and impactful industry. A heartfelt thank you to the Advanced Therapies Awards team for this recognition and congratulations to all the outstanding finalists.”
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 47,000 square foot 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 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 regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to 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).
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 its vision, continued expansion of its CDMO work and its contribution to the industry. 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
Haifa, Israel – November 25, 2024 – PLURI Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that it is assessing its readiness to initiate mass production of PLX-R18, a novel potential treatment for hematopoietic complications of the acute radiation syndrome (H-ARS) following exposure to nuclear radiation, in response to heightened global tensions and escalating nuclear threats, particularly in Ukraine.
PLX-R18 has shown potential promise in significantly improving survival and accelerating recovery from H-ARS in preclinical animal and human studies, conducted with support from leading global health and U.S. defense agencies. PLX-R18 demonstrated the ability to stimulate blood cell regeneration and potentially mitigate the effects of radiation exposure.
H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as those which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by a dose-dependent bone marrow depression, leading to neutropenia, thrombocytopenia, anemia, and possibly death. The U.S. Food and Drug Administration (“FDA”) previously approved an Investigational New Drug application for PLX-R18 for the treatment of H-ARS in the case of nuclear or radiological or incidents and granted it Orphan Drug Designation.
Beyond what is required for ongoing clinical studies, the Company is actively examining the steps required to ramp up production in the event of increased and urgent global demand. PLURI’s state-of-the-art manufacturing facility is designed to handle large-scale production of cellular therapies and could be mobilized to scale up to mass production, if necessary.
“At Pluri, we stand ready to support communities in need by leveraging our expertise to respond to global emergencies,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “That is why we are evaluating our readiness to scale production if global circumstances escalate and demand arises. We believe that our proactive approach will ensure global preparedness.”
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 regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to 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).
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 use of PLX-R18 as a potential treatment for hematopoietic complications of H-ARS, that its manufacturing facility’s ability to handle large-scale production of cell therapies could be mobilized to scale up to mass production and its belief that its proactive approach will ensure global preparedness. 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.
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
HAIFA, Israel – October 28, 2024 – Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) (“Pluri” or the “Company”), a leading biotechnology company that transforms cells into solutions, today announced that the Israel Innovation Authority (“IIA”) will fund Pluri’s collaboration with the Bar-Ilan University Research and Development Company Ltd., (“BIRAD”), the commercial arm of Bar-Ilan University, to support the continued development of Placental Mucosal Associated Invariant T (“MAIT”) cells for solid tumors. MAIT cells are known to have unique advantages compared to conventional T-cells but have previously been difficult to expand and scale for clinical investigation and potential commercialization. MAIT cells are believed to be particularly suitable for the treatment of solid tumors, a significant unmet medical need.
Under this collaboration, Prof. Cohen’s novel Siglec-based Chimeric Switch Receptors (“CCR”) will be integrated into Pluri’s CAR-MAIT cell therapy platform to significantly enhance CAR-MAIT’s efficacy and tumor specificity. By leveraging the complementary strengths of both parties, Pluri’s expertise in the MAIT cell platform and the experience of Prof. Cohen’s group in developing clinically relevant and optimized T-cell genetic modification vectors, this collaboration is poised to advance innovative allogeneic cell therapies targeting solid tumors. The IIA will fund Pluri and BIRAD’s collaboration over the next year, with an option of funding an additional year. The goal of this collaboration is to effectively integrate both innovative technologies and advance to preclinical studies.
As announced in May 2024, Pluri leveraged two decades of cell expansion expertise and its proprietary technology to create a novel, patented method for expansion of immune cells. Pluri’s MAIT cells are isolated from healthy human placentas, a source rich in highly potent immune cells. Notable characteristics of Pluri’s placental MAIT cells include their potency as effector cells, their potential ability to target tumors through multiple mechanisms, and their expression of high levels of various chemokine receptors, which facilitate their migration to tumor sites. MAIT cells hold unique properties that minimize their likelihood of inducing Graft versus Host Disease (GvHD), a serious complication associated with other potential allogeneic products.
“I’m thrilled to collaborate with Pluri on this innovative project to be supported by the Israel Innovation Authority,” said Prof. Cyrille Cohen. “By combining our patent pending Siglec-based receptor technology and our expertise in designing potent CAR vectors for clinical applications, together with Pluri’s advanced capabilities in cultivating MAIT cells, we aim to harness the unique biological properties of these cells. While immunotherapy has shown great success in treating blood cancers, an equivalent success has yet to be duplicated in solid tumor malignancies. This collaboration offers the potential to overcome that challenge by creating powerful, off-the-shelf CAR T-cell therapies that specifically target solid tumors.”
“For over two decades, our team has been at the forefront of cell therapy research. We are excited to partner with BIRAD to combine our MAIT platform with Prof. Cohen’s innovative CCR technology,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “This promising collaboration, recognized by the Israel Innovation Authority for its innovative potential, will help us create more effective immunotherapies for patients with solid cancer. We appreciate the IIA’s support in making this possible”.
Total Addressable Market
The global cancer immunotherapy market was valued at $111 billion in 2023 and is expected to surpass $312 billion by 2033, poised to grow at a compound annual growth rate of 10.9%.
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 regenerative medicine, foodtech and agtech fields. 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 BIRAD
BIRAD – Research & Development Company Ltd. was established in order to translate new inventions made at Bar-Ilan University into useful products that can be effectively commercialized, thus strengthening the economy, promoting innovation and improving lives.
BIRAD’s innovative approach, combined with Bar-Ilan University’s rapid growth leading Israel’s growth in students’ number, including the largest Nanotechnology center in Israel and new Medical School in Safed, provides BIRAD with a wide range of opportunities. Thus, BIRAD (https://birad.biz/) offers corporate partnerships and alliances, intellectual property management, and technology commercialization through venture creation and licensing.
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 development of MAIT cells and their potential advantages, the potential size of the global cancer immunotherapy market, the integration of CCRs into Pluri’s CAR-MAIT cell therapy platform and the potential benefits resulting from the collaboration between Pluri and BIRAD. 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
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Jessica Daitch at Jessica@quantum-corp.com
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 – 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