Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”),
a leading biotech company that transforms cells into solutions that
promote wellbeing and sustainability, today announced that it has
signed a three year $4.2M contract with the U.S. National Institute
of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH). Pluri will collaborate with the U.S.
Department of Defense’s Armed Forces Radiobiology Research
Institute (AFRRI)/Uniformed Services University of Health Sciences
(USUHS) in Maryland, USA to further advance the development of its
PLX-R18 cell therapy as a potential novel treatment for
Hematopoietic Acute Radiation Syndrome (H-ARS). H-ARS is a deadly
disease that can result from nuclear disasters and radiation
exposure.
Recent geo-political events have reinforced the
need for the global community to better prepare for nuclear
disasters, such as seeking new medical treatments that are more
cost-efficient and scalable than current options that can be
proactively administered in advance of a potential nuclear event.
H-ARS, also known as radiation poisoning, is caused by exposure to
life-threatening amounts of ionizing radiation, such as what may
occur during nuclear/radiological accidents, terrorist activities
and warfare. H-ARS is characterized by dose dependent bone marrow
depression, leading to life-threatening neutropenia,
thrombocytopenia and anemia, and possible death.
This contract supports Pluri’s goal to achieve
marketing approval for PLX-R18 with the U.S. Food and Drug
Administration (FDA), which could qualify the product to be
purchased for the U.S. Strategic National Stockpile as a
medical countermeasure for exposure to radiation. The FDA
previously cleared an Investigational New Drug (IND) application
for PLX-R18 for the treatment of ARS in the case of nuclear events
and granted it Orphan Drug Designation.
Pluri will collaborate with Prof. Vijay K. Singh
of AFRRI, a world-renowned expert in radiation treatments. His
laboratory’s primary research interest is to develop radiation
countermeasures for ARS.
“The current time calls for us to accelerate the
development and accessibility of radiation treatments, especially
as geopolitical instability rises, and nuclear power plants face
the threat of warfare,” said Pluri CEO and President Yaky Yanay.
“Through this strategic contract with NIAID, we believe that we can
realize our mission of making PLX-R18 readily available for
emergency preparedness. We look forward to collaborating with Prof.
Singh and AFRRI to explore the potential of PLX-R18 as a uniquely,
scalable treatment for H-ARS.”
Prof. Singh added, “PLX-R18’s potential as a
medical countermeasure for H-ARS is supported by robust human and
animal data, making it a unique asset for further investigation.
I’m eager to commence our collaborative study with Pluri and have
high expectations for results.”
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 U.S. Department of Defense (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 rate 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 cells (p = 0.0047),
platelets (p = 0.0070), neutrophils (p = 0.0003) and lymphocytes (p
= 0.0025) counts compared to administration of vehicle, and a
favorable safety profilei.
Additionally, PLX-R18 was tested in humans with
incomplete hematopoietic recovery following Hematopoietic Cell
Transplantation (HCT) 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 platelets
(p<0.001), hemoglobin (p = 0.02) and neutrophils (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 the
Contract
The purpose of the contract is to support the
development of PLX-R18 as a novel cellular medical countermeasure
for the prevention, mitigation and treatment of all aspects of
H-ARS. Through in vitro, ex vivo and animal studies, the aim is to
demonstrate the efficacy of PLX-R18, manufactured according to cGMP
standards, as a treatment even when administered 48 hours or later
following radiation exposure. Following in vitro and ex vivo
studies, mice that have been exposed to total body irradiation will
be dosed with clinical grade PLX-R18 as well as CRISPR/Cas9-edited
PLX-R18 cells. Dose regimen, radiation levels, and corresponding
increasing survival will be assessed, as well as analysis into the
mechanisms of action.
About PLX-R18PLX-R18 is a novel
cell-based medicinal product, comprised of human placenta derived
stromal cells delivered through intramuscular (im) injection. The
living cells adaptively secrete a cocktail of active hematopoietic
factors. These factors act together to produce optimal therapeutic
efficacy by facilitating the recovery of hematopoietic progenitor
cells in the bone marrow and the regeneration of multiple blood
lineage cell counts in the peripheral blood. Preclinical studies
have shown that PLX-R18 cells ameliorate or prevent the toxicity of
H-ARS. Further preclinical data from trials conducted by the NIH,
the Charité in Berlin, Indiana University (Prof. Christie M
Orschell) AFRRI (Dr. Sanchita Ghosh) and other prominent research
institutions, have shown that PLX-R18 cells secrete a range of
specific factors that salvage and trigger the regeneration of bone
marrow hematopoietic cells, thereby supporting the recovery of
blood cell production. With its capabilities, PLX-R18 could
potentially be used in several indications to treat a broad range
of hematologic disorders, which together constitute a substantial
global market.
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 wellbeing and
sustainability. The Company’s cGMP-grade technology platform, a
patented and validated state-of-the-art 3D cell expansion system,
advances novel cell-based solutions for a range of initiatives —
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, food-tech and
biologics and aims to establish partnerships that leverage the
Company’s 3D cell-based technology to additional industries that
require effective mass cell production. To learn more, visit us at
www.pluri-biotech.com or follow us on LinkedIn and 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
value of the contract and program, that the contract supports its
goal to achieve marketing approval for PLX-R18 with the FDA, the
belief that the strategic contract with NIAID can help it realize
its mission of making PLX-R18 readily available for emergency
preparedness and the potential benefits to be derived from the use
of PLX-R18. 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: Director of Investor Relations, Aviva Banczewski,
investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Nathan Miller at nathan@miller-ink.com / Meira
Feinman at meira@miller-ink.com
____________________________________________
i https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9601513/
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/d6b953ad-d810-4cca-9239-85fae1a80e01
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