HAIFA, Israel – December 19, 2024 –Pluri Inc. (Nasdaq: PLUR) (TASE:PLUR) (“Pluri” or the “Company”), an innovator in the development of leading cell-based technologies for various indications, congratulates Mesoblast Ltd. (“Mesoblast”) and its Chief Executive Officer, Silviu Itescu, on the U.S. Food and Drug Administration (the “FDA”) approval of the first MSC-based therapy for steroid-refractory acute graft-versus-host disease (“SR-aGVHD”). This landmark achievement marks a pivotal moment in the advancement of regenerative medicine and highlights the growing clinical and regulatory recognition of MSC therapies’ transformative potential.
“This milestone is not just a triumph for Mesoblast, but for the entire field of cellular medicine,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “Silviu and the team at Mesoblast have opened a new chapter in harnessing MSC therapies to treat devastating conditions like SR-aGVHD. This approval validates the immense therapeutic promise of MSCs and inspires all of us working in this space to redouble our efforts to bring innovative solutions to patients in need.”
The FDA approval also underscores the critical role of regenerative medicine in transforming healthcare systems globally. “Regenerative medicine has the potential to shift the paradigm from managing chronic conditions to enabling true healing and regeneration,” Mr. Yanay added. “By addressing the root causes of diseases rather than just their symptoms, regenerative therapies can potentially improve patient outcomes while creating more sustainable and efficient healthcare systems.”
Pluri has long championed the potential of MSCs through its proprietary platform, harnessing its unique 3D cell-expansion technology to develop robust and scalable cell-based therapies. The Company’s innovative approach positions it at the forefront of cell therapy development, enabling the creation of next-generation solutions that address critical unmet medical needs.
“At Pluri, we share a vision of a future where cell-based technologies transform lives across a spectrum of diseases,” Mr. Yanay said. “We believe that the FDA’s decision underscores the importance and opportunity to accelerate the development of MSC-based therapies globally.”
Pluri remains steadfast in its mission to expand the therapeutic boundaries of cell-based solutions , leveraging its expertise to pioneer new treatments that meet the highest standards of efficacy, safety, and accessibility. Pluri’s PLacental eXpanded cells are placenta-derived, mesenchymal-like adherent stromal cells which are being studied for the treatment of hematopoietic indications such as Acute Radiation Syndrome as well as orthopedic indications such as Knee Osteoarthritis. For more information about Pluri and its advanced cell therapy product candidates, visit https://pluri-biotech.com/solutions-pluri-health/.
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 that Mesoblast’s landmark achievement marks a pivotal moment in the advancement of regenerative medicine and highlights the growing clinical and regulatory recognition of MSC therapies’ transformative potential, that regenerative medicine has the potential to shift the paradigm from managing chronic conditions to enabling true healing and regeneration and potentially improve patient outcomes while creating more sustainable and efficient healthcare systems, that the Company’s innovative approach positions it at the forefront of cell therapy development, enabling the creation of next-generation solutions that address critical unmet medical needs, Company’s vision and mission and its belief that the FDA’s decision underscores the urgency and opportunity to accelerate the development of MSC-based therapies globally. 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
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
Collaboration aims to develop innovative production methods to increase global availability of vegetables, shorten supply chains and promote sustainable agriculture
HAIFA, Israel – July 8, 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, has announced a strategic proof of concept (“POC”) agreement with a leading international agriculture corporation. The agreement is intended to boost the global vegetable product supply, streamline supply chains, and combat global climate change while ensuring a natural and more sustainable future for agriculture.
The collaboration leverages the strengths of both companies–Pluri’s extensive expertise in cell-expansion technologies and cellular agriculture complements the partner’s global presence, knowledge of the food industry and dominant position in the vegetable market.
The result of the planned collaboration has the potential to minimize environmental impact and foster greater food security. Pluri’s proprietary 3D cell expansion technology is expected to benefit farmers worldwide, as the collaboration can build a better agronomic and environmentally friendly infrastructure, bringing sustainable, high-quality solutions to the market.
“As the global population expands, resource competition and climate change heighten the urgency to develop alternative agricultural technologies to replace traditional methods,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “This new collaboration showcases Pluri’s strategy to work with leading global companies from various industries, each an expert in their respective field. It also aligns with our ongoing commitment to generate revenue through innovative projects. We are confident that this collaboration has the potential not only to positively impact the vegetable market, but also to generate significant value for our shareholders.”
Market size
The global vegetable farming market is valued at $1.3 trillion and is expected to reach $1.6 trillion by 2029, growing at a CAGR of 3.4% from 2024 to 2029.
With over 7.5 billion people currently, the global population is steadily rising and expected to reach 8.6 billion in 2030 and 11.2 billion by the turn of the century.
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).
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 collaborations with strategic partners; the goals, aims and expected results of the collaboration; the potential benefits of the agreement and of Pluri’s 3D cell expansion technology; the expected market impacts of the collaboration; the urgency to develop alternative agricultural technologies to replace traditional methods; its business strategy; its commitment to generate revenue through innovative projects; its belief that this collaboration has the potential not only to positively impact the vegetable market, but also to generate significant value for our shareholders; and the expected market growth of the global vegetable farming market and global population.. 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/ Madeline Weirman at Maddie@quantum-corp.com
HAIFA, Israel – June 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 strategic investments in Pluri’s subsidiary, Ever After Foods Ltd. (“Ever After Foods”), which offers a cutting-edge technology platform to produce cultivated food with unmatched, cost-efficient scalability. Ever After Foods is Pluri’s majority-owned joint venture with Israeli food giant Tnuva Food-Tech Incubator (2019), L.P. (“Tnuva”), and has exclusive licensing rights to use Pluri’s technology and intellectual property to develop, manufacture and commercialize cultivated meat. The $10 million funding round will propel Ever After Foods’ cost-advantageous and scalable technology platform, positioning it as a leading technology enabler.
Leveraging on Pluri’s innovative technology, Ever After Foods has swiftly advanced its scalable production platform since introducing the pilot version last year. Developing the B2B version of its proprietary technology system, Ever After Foods has demonstrated the natural production of muscle and fat tissues for various animal cells, ensuring taste, feel, and texture akin to conventional animal-derived meat. This breakthrough technology enables partners to reduce production costs by over 90% while significantly increasing productivity.
Powered by Pluri’s technology, Ever After Foods’ bioreactors yield up to six times more protein and 700 times more lipids from each cell when compared to other cultivated meat technology platforms, offering enhanced nutritional and flavor value. With this new investment, Pluri has extended the license field granted to Ever After Foods to include cultivated fish, further expanding the reach and impact of its technology in the food industry.
“Ever After Foods’ unique and innovative production platform empowered the change to our business model. The shift to a technology enabler will allow us to serve more players in the value chain,” said Eyal Rosenthal, Chief Executive Officer of Ever After Foods. “Securing funding from new global partners is a testament to our team’s tireless dedication to solving the primary production barriers for the next step toward a more sustainable meat industry. In addition to the funding, working with new partners in the space will deepen our industry network and speed up our expansion into international markets as we drive the next era of scalable cultivated meat production.”
“The joint investment by global multinational companies, along with Tnuva and Pluri, in Ever After Foods’ unique technology platform, its team, and vision underscores the critical role of collaboration in ensuring a sustainable and secure global food system,” noted Haim Gavrieli, Tnuva’s Chairman of the Board. “The way the world produces and consumes meat will significantly change over the next decade, bringing many opportunities for cultivated meat players. As the leading alternative protein group in Israel, Tnuva recognizes the immense importance of continued investment in Israeli foodtech in general, and particularly in the field of cultivated meat.”
“The current investment round in Ever After Foods is led by new global partners, and includes Tnuva’s renewed commitment as well. We believe this validates Pluri’s strategy and underscores the quality of our technology and solutions,” explained Yaky Yanay, Chief Executive Officer and President of Pluri. “In just two years, our subsidiary has transformed the cultivated-meat sector, highlighting Pluri’s innovative 3D cell expansion technology. Pluri is dedicated to the success of Ever After Foods, and this milestone reflects our ongoing commitment to innovation and excellence. We extend our heartfelt thanks to the Ever After Foods’ management team for their dedication and hard work in driving our shared vision forward.”
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 Ever After Foods
Ever After Foods has developed a proprietary technology platform to produce cultivated meat with unmatched cost-efficient scalability. Leading the reinvention of meat by delivering an ethical, sustainable way to create slaughter-free, delicious, premium cultivated meat products at unprecedented scale, Ever After Foods is committed to bringing cultivated meat to the mass market. Learn more at https://everafterfoods.com/.
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 potential growth of Ever After Foods and its ability to empower efficient cultivated meat production at global scale, the ability of Ever After Foods to potentially tackle significant scalability challenges faced by the industry; that the $10 million funding round will support Ever After Foods’ B2B technology platform, positioning it as a sustainable technology enabler; the expansion of its reach and impact of its technology in the food industry, including international expansion; and the achievement of its vision of transforming cells into solutions that promote global wellbeing and sustainability. 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/ Madeline Weirman at Maddie@quantum-corp.com
HAIFA, Israel – June 6 , 2024 – Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) (“Pluri” or “the Company), a leading biotechnology company that transforms cells into solutions, today announced the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has exercised its option for year two of the three-year $4.2 million contract it entered into with Pluri in July 2023. During the 12 months from July 1, 2024 through June 30, 2025, the NIAID will provide $1.4 million for the Company to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo studies to develop PLX-R18 as a potential novel treatment for hematopoietic complications of the acute radiation syndrome (H-ARS).
H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as that which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by dose-dependent bone marrow depression, leading to neutropenia, thrombocytopenia, and 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.
Over the past year, Pluri has collaborated with the U.S. Department of Defense’s (DoD) Armed Forces Radiobiology Research Institute at the Uniformed Services University of Health Sciences in Bethesda, Maryland, resulting in significant advancements in the development of PLX-R18 as a potential treatment for H-ARS.
“PLX-R18 is being developed as a next-generation countermeasure against the damage caused by ionizing radiation, aiming to treat single-agent neutropenia, thrombocytopenia, and anemia. We would like to thank NIAID for its trust and for choosing to exercise its second-year option, this action validates the potential of PLX-R18 to treat H-ARS,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “We are pleased to continue working with the NIH and the DoD’s Armed Forces Radiobiology Research Institute, to advance this potential treatment for a truly devastating medical condition, especially in light of recent geopolitical events and the global threat of nuclear disasters.”
PLX-R18 has been safely tested in both humans and animals. Prior studies funded by the NIH/NIAID and conducted in accordance with the FDA’s Animal Rule pathway demonstrated that PLX-R18 administered to animals after radiation exposure for H-ARS significantly increased survival rates from 29% in the control group to 97% in the treated group (p<0.001). Studies conducted by the DoD have shown that PLX- R18, administered as a prophylactic measure 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from 4% survival in the placebo group to 74% in the treated group (log-rank test p< 0.0001). In addition, the data show a significant increase in recovery of white blood cell (p = 0.0047), platelet (p = 0.0070), neutrophil (p = 0.0003) and lymphocyte (p = 0.0025) counts compared to administration of vehicle, and also demonstrate a favorable safety profile.
PLX-R18 was tested in humans with incomplete hematopoietic recovery following hematopoietic cell transplantation and was well tolerated with a favorable safety profile. Patients treated with PLX-R18 showed an increase in all three blood cell types compared to the baseline with platelet (p<0.001), hemoglobin (p=0.02) and neutrophil (p=0.15) levels increasing as early as 1 month following PLX-R18 administration and enduring up to 12 months following treatment, while experiencing a significant reduction in mean number of transfused units from a monthly 5.09 to 0.55 for platelets (p=0.045) and 2.91 to 0 for red blood cells (p=0.0005) over 12 months of follow-up.
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 Contract Development and Manufacturing Organization (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).
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 potential benefits to be derived from the use of PLX-R18; its collaborations with strategic partners; its regulatory strategy; and that work during the contract period is expected to make further progress toward marketing approval for PLX-R18 as a medical countermeasure for exposure to nuclear radiation and lead to PLX-R18 becoming eligible for purchase by the U.S. Strategic National Stockpile. 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 / Madeline Weirman at Maddie@quantum-corp.com
HAIFA, Israel – May 20, 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 a strategic collaboration with Wilk Technologies Ltd. (TASE: WILK) (“Wilk Technologies” or “Wilk”), a developer of authentic, cell-cultured human and animal milk components. By combining Pluri’s cutting-edge 3D cell-expansion technology with Wilk’s expertise in developing cultured human breast and animal milk products, the strategic collaboration will use the components of breast milk to develop a unique medical food intended for the elderly on a commercial scale.
Medical foods for the elderly are specifically formulated and designed to meet the unique nutritional needs and health concerns of older adults. Demand for medical food products is growing, driven by the growing geriatric population and increasing prevalence of chronic illnesses impacting adults who may have nutritional deficiencies stemming from their illness or its related treatment.
“Wilk Technologies is committed to unlocking the potential of cell-based medical foods,” said Avital Beck, Ph.D., CEO of Wilk Technologies. “This collaboration presents an opportunity to leverage Pluri’s 3D cell expansion technology with Wilk’s unique cell lines. The collaboration aims to develop and scale Wilk’s innovative products to commercial readiness, potentially leading to powerful medical food for the elderly.”
“At Pluri, our mission is to leverage cell-based technology to tackle humanity’s most pressing issues, like age-related health decline and global food insecurity,” said Yaky Yanay, CEO and President of Pluri. “This collaboration with Wilk Technologies perfectly aligns with our vision as we harness the unique properties of breast milk cells to create medical food solutions for a rapidly growing elderly population. We’re thrilled about the potential of this collaboration to improve the quality of life for millions and revolutionize senior health on a global scale.”
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 Wilk Technologies Ltd.
Wilk is dedicated to revolutionizing the dairy and infant formula industry by enabling the sustainable production of high-value dairy products using the lowest carbon footprint. Leveraging over 10 years of industry-leading research, Wilk is focused on two main development tracks: cultured human breast milk ingredients and cultured cow milk ingredients. Wilk produces its solutions for various purposes: enriching infant formula with cultured breastmilk ingredients for babies, alternative dairy healthy diets, and the extrapolation of milk’s nutritional components for the pharma industry. Last year, Wilk Technologies received investments from Danone, Steakholder Foods, & Coca Cola Israel.
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 strategic collaboration, the potential to lead to powerful medical food for the elderly and the potential benefits of the collaboration. 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 / Madeline Weirman at Maddie@quantum-corp.com
HAIFA, Israel – May 2, 2024 – Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) (“Pluri” or the “Company”), a leading biotechnology company that transforms cells into solutions, today launched its placental allogeneic MAIT cell platform for immunotherapy treatment for solid tumors – a significant medical need which currently lacks effective treatments.
Leveraging two decades of cell expansion expertise and its proprietary technology, Pluri recently unveiled a novel method for expansion of immune cells as well as a new U.S. granted patent. Pluri believes that the newly announced immunotherapy platform can revolutionize solid tumor treatment and unlock the potential of placental MAIT cells, which are unique immune cells derived from healthy donors.
The Company also announced that Dr. Prasad S. Adusumilli (Min H. and Yu-Fan C. Kao Chair in Thoracic Cancers at Memorial Sloan Kettering Cancer Center) and Dr. Richard L. Kendall (Former Head of Oncology Research at Amgen), two renowned oncology researchers, joined its newly formed Scientific Advisory Board to provide strategic counsel as this project advances.
Offering substantial potential benefits compared to conventional T cells, Pluri’s MAIT cells are isolated from the human placenta, a source rich in highly potent allogeneic immune cells. These cells are potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine receptors, which facilitate their migration directly to tumor sites. Furthermore, unlike conventional T cells typically collected from peripheral blood, Pluri’s MAIT cells demonstrate a lower alloreactivity profile. This characteristic not only minimizes their likelihood of inducing Graft versus Host Disease (GvHD) – a significant advantage over other potential allogeneic products – but also suggests that they may persist in the body for a longer duration, enhancing their therapeutic efficacy.
When combined with Pluri’s 3D cell expansion technology, the MAIT platform will enable commercial scale production of powerful immune cells as a potential first-in-class, ready to use, off-the-shelf therapy for cancer patients.
“Our MAIT platform is a culmination of two decades of innovation and scientific expertise, paving the way for a new era of effective immunotherapy,” said Yaky Yanay, CEO and President of Pluri. “We believe that our MAIT cells can make targeted, affordable and effective treatments readily accessible to all who need them. Our commitment extends beyond mere technological advancement; we aim to redefine what’s possible in the fight against cancer.”
“Despite revolutionary progress in hematological malignancies, an equivalent success has yet to be duplicated in solid tumor malignancies, which present unique challenges. Pluri’s MAIT cells exhibit inherent biological advantages that may be pivotal in developing effective treatments for tough-to-treat cancers and solid tumors in particular,” said Dr. Arthur Machlenkin, PhD, Chief Scientific Officer of Pluri. “We are excited to continue developing these powerful cells into transformative therapies.”
The global cancer immunotherapy market was valued at $100 billion in 2022 and expected to surpass around $275.11 billion by 2032, poised to grow at a compound annual growth rate (CAGR) of 10.70% from 2023 to 2032.
Understanding the potential of Pluri’s MAIT cells, two internationally recognized oncology researchers joined Pluri’s Scientific Advisory Board (SAB): Dr. Prasad S. Adusumilli and Dr. Richard L. Kendall.
Dr. Adusumilli, MD, is Professor and Deputy Chief, Thoracic Service; Vice Chair for Translational Research, Dept. of Surgery; Director, Mesothelioma Program; Min H. and Yu-Fan C. Kao Chair in Thoracic Cancers at Memorial Sloan Kettering Cancer Center (New York, NY). Research led by Dr. Adusumilli has focused on regional immunotherapy strategies, resulting in translation of mesothelin-targeted CAR T-cell immunotherapy for malignant pleural mesothelioma, lung, and breast cancers.
“I am excited to work with Pluri to develop scalable, engineered immune cells for cancer immunotherapy,” said Dr. Prasad S. Adusumilli. “The cells’ intrinsic ability to migrate to tumor sites can offer a beacon of hope in the fight against solid tumors, a significant unmet medical need.”
Dr. Kendall, Ph.D, is Chief Science Officer of Catena Bio, a company whose technology enables them to synthesize novel biomolecules in any structure, combination, or orientation. Previously, Dr. Kendall was the President and CEO of ImmPACT BIO, a cell therapy company developing engineered T cells for the treatment of cancer. Notably, Dr. Kendall also held significant positions at leading biopharmaceutical companies, serving as Vice President of Research at Kite Pharma, where he was responsible for the company’s research pipeline and development of CAR-T technologies, as well as Executive Director and Head of Oncology Research at Amgen.
“By combining advanced cell expansion technology with the unique attributes of MAIT cells, Pluri is on the brink of delivering off-the-shelf solutions with unmatched consistency,” Said Dr. Richard L. Kendall.
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).
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 potential of its technology and the placental allogeneic MAIT cell platform for immunotherapy treatment for solid tumors, the potential of the MAIT cells and its characteristics and benefits in comparison to conventional T cells, the belief that the newly announced immunotherapy platform can revolutionize solid tumor treatment and unlock the potential of placental MAIT cells, the MAIT cells’ advantage over other potential allogeneic products, Pluri’s belief that the MAIT platform will enable commercial scale production of powerful immune cells as a potential first-in-class, ready to use, off-the-shelf therapy for cancer patients and the belief that the MAIT cells can make targeted, affordable and effective treatments readily accessible to all who need them. . 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 / Madeline Weirman at Maddie@quantum-corp.com
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