Pluri Evaluates Readiness for Mass Production of PLX-R18 for Acute Radiation Syndrome Amid Rising Nuclear Threat Concerns
Pluri Inc. (Nasdaq: PLUR) is evaluating its readiness for mass production of PLX-R18, a potential treatment for hematopoietic complications of acute radiation syndrome (H-ARS). The assessment comes amid heightened global nuclear threats, particularly in Ukraine. PLX-R18 has shown promise in improving survival and accelerating recovery from H-ARS in preclinical studies, with support from U.S. defense agencies. The treatment has received FDA's Orphan Drug Designation and IND approval for H-ARS treatment. The company's manufacturing facility is equipped for large-scale cellular therapy production and could be mobilized for mass production if needed.
Pluri Inc. (Nasdaq: PLUR) sta valutando la sua prontezza per la produzione di massa di PLX-R18, un potenziale trattamento per le complicanze ematologiche della sindrome acuta da radiazione (H-ARS). La valutazione avviene in un contesto di crescenti minacce nucleari globali, in particolare in Ucraina. PLX-R18 ha mostrato promesse nel migliorare la sopravvivenza e accelerare il recupero da H-ARS in studi preclinici, con il supporto delle agenzie di difesa statunitensi. Il trattamento ha ricevuto la Designazione di Farmaco Orfano e l'approvazione IND da parte della FDA per il trattamento dell'H-ARS. L'impianto di produzione dell'azienda è attrezzato per la produzione di terapia cellulare su larga scala e potrebbe essere mobilitato per la produzione di massa, se necessario.
Pluri Inc. (Nasdaq: PLUR) está evaluando su preparación para la producción en masa de PLX-R18, un tratamiento potencial para las complicaciones hematológicas del síndrome agudo por radiación (H-ARS). La evaluación se lleva a cabo en medio de crecientes amenazas nucleares globales, especialmente en Ucrania. PLX-R18 ha mostrado promesas en mejorar la supervivencia y acelerar la recuperación de H-ARS en estudios preclínicos, con el apoyo de las agencias de defensa de EE.UU. El tratamiento ha recibido la Designación de Medicamento Huérfano y la aprobación IND de la FDA para el tratamiento de H-ARS. La instalación de fabricación de la empresa está equipada para la producción de terapia celular a gran escala y podría movilizarse para la producción en masa si es necesario.
Pluri Inc. (Nasdaq: PLUR)는 급성 방사선 증후군(H-ARS)의 조혈 합병증에 대한 잠재적 치료제인 PLX-R18의 대량 생산 준비 상태를 평가하고 있습니다. 이 평가는 특히 우크라이나에서의 증가하는 글로벌 핵 위협 속에서 이루어집니다. PLX-R18은 비임상 연구에서 H-ARS로부터의 생존 개선과 회복 가속화에서 약속을 보여주었으며, 미국 방위 기관들의 지원을 받고 있습니다. 이 치료법은 H-ARS 치료를 위한 FDA의 희귀 약물 지정 및 IND 승인을 받았습니다. 회사의 제조 시설은 대규모 세포 치료 생산에 맞춰져 있으며, 필요할 경우 대량 생산을 위해 동원될 수 있습니다.
Pluri Inc. (Nasdaq: PLUR) évalue sa préparation pour la production de masse de PLX-R18, un traitement potentiel pour les complications hématologiques du syndrome aigu de radiations (H-ARS). Cette évaluation intervient dans un contexte de menaces nucléaires globales croissantes, notamment en Ukraine. PLX-R18 a montré des promesses pour améliorer la survie et accélérer la récupération du H-ARS lors d'études précliniques, avec le soutien des agences de défense américaines. Le traitement a été désigné médicament orphelin par la FDA et a reçu l'approbation IND pour le traitement de H-ARS. L'installation de fabrication de l'entreprise est équipée pour la production de thérapies cellulaires à grande échelle et pourrait être mobilisée pour la production en masse si nécessaire.
Pluri Inc. (Nasdaq: PLUR) bewertet seine Bereitschaft zur Massenproduktion von PLX-R18, einer potenziellen Behandlung für hämatologische Komplikationen des akuten Strahlensyndroms (H-ARS). Diese Bewertung erfolgt vor dem Hintergrund gesteigerter globaler nuklearer Bedrohungen, insbesondere in der Ukraine. PLX-R18 hat sich in präklinischen Studien als vielversprechend erwiesen, um die Überlebensrate zu verbessern und die Genesung von H-ARS zu beschleunigen, unterstützt von US-Verteidigungsbehörden. Die Behandlung hat von der FDA die Orphan Drug Designation sowie die IND-Zulassung für die Behandlung von H-ARS erhalten. Die Fertigungsanlage des Unternehmens ist für die Herstellung von Zelltherapien in großem Maßstab ausgestattet und könnte bei Bedarf zur Massenproduktion mobilisiert werden.
- FDA has approved IND application for PLX-R18
- Product has received Orphan Drug Designation
- Company has manufacturing facility capable of large-scale production
- Positive preclinical study results in treating H-ARS
- Product still in preclinical stage, not yet approved for commercial use
- Uncertain timeline for potential commercialization
- No confirmed market demand or contracts yet
Insights
PLX-R18's potential for treating Acute Radiation Syndrome (H-ARS) represents a significant medical advancement in a critical area lacking effective treatments. The therapy's ability to stimulate blood cell regeneration addresses a fundamental challenge in radiation exposure treatment. The FDA's prior IND approval and Orphan Drug Designation validate the program's scientific merit and market potential.
While Pluri's manufacturing readiness assessment is important, several key factors need consideration:
- Current manufacturing capacity and scalability metrics are not disclosed
- Timeline for potential mass production remains undefined
- No specific contracts or orders are mentioned
- Market size and pricing strategy are unclear
HAIFA, Israel, Nov. 25, 2024 (GLOBE NEWSWIRE) -- 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.
Scaling Up Production
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.”
About Pluri
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global 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 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.
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
FAQ
What is PLX-R18's current development status for radiation syndrome treatment?
What regulatory approvals has Pluri (PLUR) received for PLX-R18?
Is Pluri (PLUR) currently mass-producing PLX-R18?
