U.S. National Institutes of Health Exercises Option to Fund $1.4 Million 2nd Year Budget for Pluri’s PLX-R18 Acute Radiation Syndrome Contract
Pluri announced that the U.S. National Institute of Allergy and Infectious Diseases (NIAID) has exercised a $1.4 million second-year funding option for a contract to develop PLX-R18, a cell therapy for Acute Radiation Syndrome (H-ARS). The contract, part of a $4.2 million three-year agreement, supports manufacturing, in vitro, and in vivo studies for PLX-R18. The therapy aims to counteract hematopoietic complications from ionizing radiation. Significant survival rate increases in both animal and human studies have been reported. PLX-R18 has also received FDA Orphan Drug Designation.
- NIAID's $1.4 million funding supports further development of PLX-R18.
- PLX-R18 aims to treat hematopoietic complications from ionizing radiation, a critical need.
- Animal studies show significant survival rate increases from 29% to 97%.
- FDA Orphan Drug Designation granted for PLX-R18.
- Collaboration with the U.S. Department of Defense has advanced PLX-R18.
- Human trials show favorable safety and increased blood cell counts.
- Reduces mean number of transfused units for platelets and red blood cells over a year.
- Dependence on government funding for project continuation.
- Potential delays in FDA approval may impact market entry.
- Risk of not meeting marketing approval criteria for Strategic National Stockpile procurement.
- High cost associated with the development and testing of PLX-R18.
- Uncertainty regarding long-term efficacy and safety in broader patient populations.
Insights
The NIAID's decision to fund the second year of the contract with Pluri provides a direct infusion of
From a financial perspective, this milestone can be seen as a positive indicator for Pluri’s cash flow and financial health. The backing of a government entity reduces the risk associated with the project and can lead to future contracts and funding opportunities. Investors will likely view this as a step towards the company's long-term sustainability and product pipeline robustness.
However, it’s important to note that while the funding is beneficial, it does not guarantee FDA approval or market success. The eventual commercial viability depends on successful clinical outcomes and regulatory milestones which are inherently uncertain.
The ongoing funding for PLX-R18 research indicates substantial progress in developing a novel treatment for acute radiation syndrome (H-ARS). This experimental therapy targets hematopoietic complications such as neutropenia, thrombocytopenia and anemia, which are critical medical issues following radiation exposure.
PLX-R18's demonstrated efficacy in preclinical trials, where it significantly improved survival rates and blood cell recovery, is a promising indicator. The FDA’s Orphan Drug Designation and prior investigational status add credibility to the development program, suggesting that the therapy addresses an unmet medical need with potential life-saving benefits.
For stakeholders, this continued investment is a signal of the potential utility of PLX-R18 in emergency preparedness and public health. However, translating these preclinical successes to human clinical outcomes remains a critical hurdle, making ongoing research and trials pivotal.
The strategic importance of PLX-R18, especially with current geopolitical tensions and the global threat of nuclear incidents, cannot be overstated. The potential to secure a place in the U.S. Strategic National Stockpile offers a substantial market opportunity. This would position Pluri as a key player in emergency medical countermeasures.
The current funding not only facilitates critical research but also enhances the company’s market positioning. The partnership with government entities like the NIH and the DoD lends significant credibility and opens doors to further strategic collaborations and larger procurement contracts.
Nevertheless, the market potential hinges on successful FDA approval and the scalability of production to meet emergency demands quickly. While the news is positive, investors should keep an eye on regulatory updates and production capabilities to assess the long-term commercial impact.
- As part of Pluri’s previously announced
$4.2 million 3-year contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), the option for the second year of the contract has been exercised to fund manufacturing, in-vitro, and in-vivo studies of Pluri’s cell therapy - PLX-R18 is designed to be a first in class, effective treatment for ionizing radiation injuries that could be anticipated in the wake of a large-scale nuclear incident
- Work during the contract period is expected to make further progress toward marketing approval for PLX-R18 as a medical countermeasure for exposure to radiation and lead to PLX-R18 becoming eligible for procurement by the U.S. Strategic National Stockpile, following FDA approval
HAIFA, Israel, June 06, 2024 (GLOBE NEWSWIRE) -- 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
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
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
FAQ
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