Predictive Oncology (NASDAQ: POAI) has, with the announced
acquisition of Soluble Therapeutics, Inc. and the subsequent
partnership and licensing of a novel nanoparticle vaccine platform
recently developed by Dr. Daniel Carter, entered the race to
develop a COVID-19 vaccine. The groundbreaking vaccine
technology being developed by Dr. Carter is based on a
self-assembling nanoparticle called NSP-10 (NSP is Non Specific
Protein) which follows a foundational vaccine platform developed
earlier by Dr. Carter and his team, using another self-assembling
protein called ferritin (1), an iron storage protein found in all
living things. The ferritin platform is currently exploited
by NIH in its exploration of the universal flu vaccine which
completed phase I clinical trials earlier this year and is
currently recruiting for a second Phase 1 trial on a modified
version of the ferritin self-assembly universal vaccine (2,3). POAI
has entered into an agreement with Dr. Carter under which POAI is
licensing this technology, subject to certain conditions including
additional documentation.
NSP-10 is a newly patented self-assembling nanoparticle
technology sometimes referred to as virus-like particles or VLP
(4). Called a nanoparticle because of its small size,
typically 10-12 nanometers in diameter and self-assembling because
a single small subunit has the built-in “self-assembly”
instructions to form engineered complex Virus Like Particle (“VLP”)
assemblies. They can be thought of as “smart-Legos”, so that
when a large number are thrown together, they automatically
self-assemble into the same large complex structures – in this case
the vaccine. In the case of a DNA vaccine, the DNA instructs
the body’s cells to make the Legos in mass which assemble into
numerous vaccine particles.
This is a brand-new technology, published on January 4th, 2020
in Journal of Nanomaterials and the associated patent has just
received notice of allowance from the US Patent Office in February
2020 (4,5). In addition to its publication during the
beginning of the current coronavirus epidemic, its self-assembling
elements are coincidentally based on an obscure gene regulatory
protein found in the original SARS-CoV-1 coronavirus.
According to Dr. Carter, principal inventor of the ferritin
self-assembling nanoparticle platform (1), now widely applied by
many, including NIH, to other applications and principal inventor
of the new NSP10 approach, “NSP10 is a ‘game changer’ vaccine
platform with significant advantages over current
state-of-the-art. These game changer properties have also
been validated with SARS-CoV-2 vaccine candidates – resulting in
extraordinary animal titers against the coronavirus spike protein
which is required for viral infectivity – all with a simple
injection of small quantities of DNA.”
- NSP-10 is especially interesting because it has structural
properties permit the rapid creation of nanoparticle vaccines for a
broad spectrum of viruses and microbes in a “click and play” type
design process.
- They exhibit an ability to induce exceptional vaccine titers as
either a protein or DNA-based vaccines, often as much as 10 to 100
times higher titers (more antibodies against the target) than
traditional vaccines; and
- They have the potential to rapidly move an effective DNA
vaccine into the field with numerous advantages in safety,
production, stability, distribution and administration.
The NSP COVID-19 vaccine has produced atypically strong titers
against the coronavirus spike protein in small animals using a
single small dose of plasmid-based DNA. Plasmid DNA is
extremely safe, non-replicating, non-viral and can be produced in
large quantities by established methods.
Vaccine in support of a Phase I clinical trial is in production
with expected delivery later this month.
Predictive Oncology’s next step, in support of its partnership
with Dr. Carter, is seeking quotes for a Phase 1 clinical trial
from one or more of the BARDA approved CROs.
There is no assurance that a vaccine will be successfully
developed using this technology, or that definitive documentation
of all arrangements will be completed. As previously announced,
POAI has taken over the operation of Soluble Therapeutics, which is
also working on applications that can aid in COVID-19 development,
and POAI this acquisition to be completed in the first part of
May.
References:
- 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)
- Influenza HA Ferritin Vaccine, Alone or in Prime-Boost Regimens
with an Influenza DNA Vaccine in Healthy Adults: Link:
https://www.clinicaltrials.gov/ct2/show/NCT03186781?term=ferritin&cond=influenza&draw=2&rank=1
- Dose, Safety, Tolerability and Immunogenicity of an Influenza
H1 Stabilized Stem Ferritin Vaccine, VRCFLUNPF099-00-VP, in Healthy
Adults: Link:
https://www.clinicaltrials.gov/ct2/show/NCT03814720?term=ferritin&cond=influenza&draw=2&rank=2
- D.C. Carter, W. Gray Jerome, B. Wright, 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).
- 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.
Creator of highly successful self-assembling nanomaterial
platforms for vaccine, therapeutic and diagnostic applications
Internationally recognized authority on serum albumin structure and
drug transport chemistry at the atomic scale. A pioneer in
microgravity crystal growth hardware development and related
science support services.
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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