Predictive Oncology (NASDAQ Symbol POAI) is licensing and partnering this groundbreaking NSP10 technology in the race to deve...
May 14 2020 - 8:30AM
Predictive Oncology (NASDAQ: POAI) has, with the announced
acquisition of Soluble Therapeutics and the subsequent partnership
and licensing of a novel nanoparticle vaccine technology platform
recently developed by Dr. Daniel Carter, entered the race to
develop a COVID19 vaccine. The ground-breaking vaccine
technology is based on a self-assembling nanoparticle called NSP10
which follows a foundational vaccine platform developed earlier by
Dr. Carter and his team, using another self-assembling protein
called ferritin (1).
NSP10 Vaccine Technology: How Does it
work and Why is it a “Game Changer”?
NSP10 Nanoparticle has special surface
properties that allow for the rapid design and display of viral
receptor stems for virtually any virus, making it extremely
versatile. “Couple these properties with the extraordinary
immunogenic properties and you have a potentially “game changing”
technology,” according to Dr. Joel Dobbs, a retired pharmaceutical
industry executive, who is now Executive-in-Residence at UAB’s
Collat School of Business, “this is a truly transitional technology
that could change the way vaccines are made in the future.”
Previous vaccine studies of NSP10-based
Nanoparticles in rabbits produced exceptionally high titers against
a herpes viral protein called glycoprotein D, normally non-highly
antigenic (Titer refers to the number of times the blood serum can
be diluted and still react with the virus antigen). Titers in this
case ranged from 1:1,000 with a simple injection of 500 micrograms
of plasmid DNA, to as much as 1:25,000 after a second booster
(third injection) - all without the use of adjuvants or
transfection agents (2). To our knowledge, this is
unprecedented and revolutionary for a DNA vaccine. The exact
reasons why the NSP10-based Nanoparticles exhibit these properties
is still a subject of study, but scientists know that nanoparticles
are processed differently by the immune system (3) and smaller
nanoparticles can often produce higher titers – NSP is one of the
smallest currently evaluated.
The level of titer is important for many
reasons, for example, earlier animal experiments with vaccines
focused on severe acute respiratory syndrome (SARS) and Middle East
respiratory syndrome (MERS) found that low antibody levels could
potentially lead to dysfunctional immune responses, increasing
infection and damaging the lungs (4). In addition to enhanced
protective immunity, stronger titers mean that it takes less
vaccine per dose which has added advantages in safety and
production scale. In the special case of NSP10-based
vaccines, as it translates to humans, this could mean that a single
gram of plasmid DNA can potentially immunize as many as 2,000
people, perhaps more. According to Dr. Daniel Carter, the
inventor of this technology (5), “this suggests that if we see
similar titers in humans, no atypical resources or capabilities are
required to manufacture the vaccine at a sufficient scale to impact
the pandemic.” For example, a single bacterial fermentation
at commercial scale can in a span of 2 to 3 days, produce enough
raw material to eventually immunize millions of people - “merge
this with the well-established processes for purifying
injectable-grade plasmid DNA (which can also be done in short
order) and you have the potential for a disruptive game
changing technology,” said Dr. Carter.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/99c5c11c-8099-44a7-af8d-8531cc437011
- D. C. Carter and C. Li, “Genetically Engineered Ferritin as a
Vehicle for Vaccine Production, Biomaterials, Oxygen Transport, and
Therapeutic Delivery, issued in Germany, France, United
Kingdom, China and Canada, US Patent No. 7,097,841(2006).
- D.C. Carter, B. Wright, W. Gray Jerome, J. Rose and E. Wilson,
“ A Unique Protein Self-Assembling Nanoparticle with Significant
Advantages in Vaccine Development and Production, J. of
Nanomaterials, Vol 2020, Article ID: 4297937 (2020).
- Tokatlian T, Read BJ, Jones CA, Kulp DW, Menis S, Chang JYH, et
al. Innate immune recognition of glycans targets HIV nanoparticle
immunogens to germinal centers. Science. 363(6427):649-54
(2019).
- J. Cohen, “COVID19 Shot Protects Monkeys,” Science, 368(6490),
456-467 (2020).
- D. C. Carter, “NSP10 Self-Assembling Fusion Proteins for
Vaccines, Therapeutics, Diagnostics and other Nanomaterial
Applications,” US Patent Appln: US2018/0326044 Issuing (2020),
Canada Pending.
About Dr. Carter
Dr. Carter has over 30 years of experience in
the leadership and management of science in both the government and
private sectors with core science expertise in molecular structural
biology, protein engineering, protein production and microgravity
science and applications. He has maintained an internationally
recognized research program throughout his career, authoring over
60 peer reviewed papers which include publications in Science,
Nature and PNAS and is the inventor on more than 24 patents. His
publications are highly cited (~13,500) with a current h-index
ranking of 40.
Dr. Carter’s research focus areas include: (1)
understanding the atomic structure and chemistry of albumin, the
principal protein of the circulatory system and key pharmacokinetic
effector of virtually all pharmaceuticals; (2) development and
applications of self-assembling nanomaterial platforms for vaccine,
therapeutic and diagnostic applications; and (3) microgravity
science and applications.
Prior to his career in the commercial biotechnology sector, Dr.
Carter was employed by NASA for a period of 11 years in
progressively more responsible positions including Chief of the
Biophysics and Advanced Materials Branch, as well as, the
prestigious SST appointment as the NASA Senior Scientist for
Biophysics. While at NASA and New Century Pharmaceuticals,
Inc., Dr. Carter also served as the Principal Investigator on an
extensive series of multi-user microgravity protein crystal growth
experiment payloads carried out on board the Space Shuttle, Mir and
International Space Station, which included a large international
co-investigator group of scientists from academics and industry.
During his tenure at NASA, Dr. Carter was the recipient of many
awards including NASA Inventor of the Year Awards and the NASA
Exceptional Service Medal.
About Predictive Oncology Inc.
Predictive Oncology (NASDAQ: POAI) operates through three
segments (Domestic, International and other), which contain four
subsidiaries; Helomics, TumorGenesis, Skyline Medical and Skyline
Europe. Helomics applies artificial intelligence to its rich data
gathered from patient tumors to both personalize cancer therapies
for patients and drive the development of new targeted therapies in
collaborations with pharmaceutical companies. Helomics’
CLIA-certified lab provides clinical testing that assists
oncologists in individualizing patient treatment decisions, by
providing an evidence-based roadmap for therapy. In addition to its
proprietary precision oncology platform, Helomics offers boutique
CRO services that leverage its TruTumor(TM), patient-derived tumor
models coupled to a wide range of multi- omics assays (genomics,
proteomics and biochemical), and an AI-powered proprietary
bioinformatics platform to provide a tailored solution to its
clients’ specific needs. Predictive Oncology’s TumorGenesis
subsidiary is developing a new rapid approach to growing tumors in
the laboratory, which essentially “fools” cancer cells into
thinking they are still growing inside a patient. Its proprietary
Oncology Discovery Technology Platform kits will assist researchers
and clinicians to identify which cancer cells bind to specific
biomarkers. Once the biomarkers are identified they can be used in
TumorGenesis’ Oncology Capture Technology Platforms which isolate
and help categorize an individual patient’s heterogeneous tumor
samples to enable the development of patient specific treatment
options. Helomics and TumorGenesis are focused on ovarian cancer.
Predictive Oncology’s Skyline Medical division markets its patented
and FDA cleared STREAMWAY System, which automates the collection,
measurement and disposal of waste fluid, including blood,
irrigation fluid and others, within a medical facility, through
both domestic and international divisions. The company has achieved
sales in five of the seven continents through both direct sales and
distributor partners. For more information, please visit
www.Predictive-Oncology.com.
Forward-Looking Statements
Certain of the matters discussed in this press release contain
forward-looking statements that involve material risks to and
uncertainties in the Company’s business that may cause actual
results to differ materially from those anticipated by the
statements made herein. Such risks and uncertainties include:
we may not be able to continue operating without additional
financing; current negative operating cash flows; the terms of any
further financing, which may be highly dilutive and may include
onerous terms; no assurance that a vaccine will be successfully
developed in collaboration with Dr. Daniel Carter, or that
definitive documentation of all arrangements with Dr. Carter will
be completed, risks related to the 2019 merger with Helomics
including; 1) significant goodwill could result in further
impairment; 2) possible failure to realize anticipated benefits of
the merger; 3) costs associated with the merger may be higher than
expected; 4) the merger may result in the disruption of our
existing businesses; and 5) distraction of management and diversion
of resources; risks related to our partnerships with other
companies, including the need to negotiate the definitive
agreements; possible failure to realize anticipated benefits of
these partnerships; and costs of providing funding to our partner
companies, which may never be repaid or provide anticipated
returns; risks related to the transaction with Quantitative
Medicine including: 1) completion of the transaction; 2) possible
failure to realize anticipated benefits of the merger; 3) costs
associated with the merger may be higher than expected; 4) the
merger may result in the disruption of our existing businesses; and
5) distraction of management and diversion of resources; risk that
we will be unable to complete the transaction with InventaBioTech
to acquire Soluble Therapeutics and BioDtech; risk that we will be
unable to protect our intellectual property or claims that we are
infringing on others’ intellectual property; the impact of
competition; acquisition and maintenance of any necessary
regulatory clearances applicable to applications of our technology;
inability to attract or retain qualified senior management
personnel, including sales and marketing personnel; risk that we
never become profitable if our product is not accepted by potential
customers; possible impact of government regulation and scrutiny;
unexpected costs and operating deficits, and lower than expected
sales and revenues, if any; adverse results of any legal
proceedings; the volatility of our operating results and financial
condition; and, and management of growth and other risks and
uncertainties that may be detailed from time to time in the
Company’s reports filed with the SEC, which are available for
review at www.sec.gov.
Investor Relations Contact:
Hayden IRJames
Carbonara(646)-755-7412james@haydenir.com
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