Predictive Oncology’s TumorGenesis Division Secures First Commercial Sale of its Novel Ovarian Cancer Cell Media
June 18 2020 - 8:30AM
Predictive Oncology Inc. (NASDAQ: POAI) (“Predictive” or “the
Company”) a knowledge-driven company focused on applying artificial
intelligence to personalized medicine and drug discovery, today
announces that Predictive’s TumorGenesis division sold its first
order of its unique ovarian cancer cell culture media for cancer
cells collected from patient derived samples (PDx) through its
distributor US Biological Corporation. The media used to grow the
novel and unique ovarian cancer cell lines, licensed by
TumorGenesis and its partner, GLG Pharma are able to retain 95%+ of
the DNA and RNA as well as crucial proteomic signatures. The media
was sold to a top rated medical university in the New England area
for research in isolating and growing ovarian cancer cells from the
fluid often found in the abdomen of women with advanced ovarian
cancer, called the ‘ascites’ fluid. Ovarian cancer cell culturing
from ascites fluids are notoriously difficult using standard media
mixes often prone to failure and cell lines that are not
representative of the patient’s ovarian cancer.
A recent publication highlighted the waste in research using
unvalidated media and reagents that showed an increase from $28
billion in 20151 to 2020 experiments are the foundation of
preclinical research and development, however, irreproducibility
rates in preclinical experiments exceed 50%, costing the industry
nearly $48 billion annually2.
“Capturing and culturing and then being able to study ovarian
cancer cell types has always been limited by the ability to grow
reproducible cultures that reflect what is in the patient”, said
Richard Gabriel of TumorGenesis. “We now have isolated and grown 25
ovarian cancer cell types, 11 of that library, represents nearly
95% of all ovarian cancers, many of which have never been cultured
prior to this time. This new media will allow researchers around
the world to isolate and then culture ovarian cancer cell types and
culture them reproducibly to find new targets for treatment,
diagnostics or other studies on the close interrelationship of
ovarian cancer tumor populations and how they are able to fool a
patient’s immune system”, Mr. Gabriel highlighted.
Researchers around the world can now contact US Biological
Corporation or Richard Gabriel at TumorGenesis for information on
the new media(s) available - rgabriel@tumorgenesis.net.
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™, 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 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.
TumorGenesis, Inc. a wholly owned subsidiary specializes in
media’s that help cancer cells grow and retain their DNA/RNA and
proteomic signatures providing researchers with a tool to expand
and study cancer cell types found in tumors of the blood and organ
systems of all mammals, including humans. In addition, TumorGenesis
is developing a ‘biomarker discovery’ kit and service for life
science, pharmaceutical and biotech companies, and research
institutions. Its products are sold on-line as well as through a
global distributor; US Biologicals Corporation:
http://www.usbio.net.
Soluble Biotech Inc., a division of Predictive Oncology Inc. has
a technology that allows the company to screen proteins for both
solubility and stability. The proteins that have been successfully
improved by Soluble include vaccines, antibodies and other proteins
used in disease treatment. The company can screen 12,000 possible
combinations of formulations of any protein using an exceedingly
small amount, 25 milligrams and uses a neural network (AI) and
other programs to predict the best formulation combination. It
confirms the formulations by making a soluble and stable protein
solution. The team at Soluble has worked on other viruses and
deadly bacteria to come up with formulations of target proteins
that can be used to treat, diagnose, or identify specific protein
targets for later drug design. Soluble is expanding its reach by
offering its services to COVID-19 antibody and vaccine developers.
By having a soluble and stable antibody or vaccine candidate at the
highest concentration is not only important for final delivery but
is also a critical component in pre-clinical testing in animal
models as well as in in vitro assays. Over the last 7 years,
Soluble has worked for many large pharmaceutical and biotech
companies but has also helped smaller companies that mostly
outsource their development to outside service companies. Along
with the 4 operating machines, each capable of 12,000 screens per
machine, it also sells individual kits for researchers whose
budgets are constrained.
Soluble Biotech Inc. also specializes in removing, identifying,
and isolating endotoxins from products that are used by researchers
to culture cells and to help identify endotoxins that maybe hidden
within a protective matrix. A notable example is its recent success
in completion of a Phase 2 SBIR grant (July 2020 for final report)
for the identification of endotoxins in patient samples that have
HIV and are experiencing a syndrome known as ‘leaky gut’, where
patients in its end result would succumb to septicemia. BioDtech’s
detection of the endotoxin in the patient sample, alerts the
clinician to start the appropriate therapy ahead of the
presentation of the septicemia event. This test also works for
patients with Crohn’s disease, ulcerative colitis disease or as a
side effect of other drug treatments, such as chemotherapy and
radiation. BioDtech’s products include a column of beads that
extract endotoxins from samples as well as other kits to release
bound endotoxins, improving their detection.
Forward-Looking Statements
Portions of the narrative set for this document
that are not statements of historical or current facts are
forward-looking statements, in particular, the commercial outlook
provided above. Our actual future performance may materially differ
from that contemplated by the forward-looking statements as a
result of a variety of factors.
These factors include, in addition to those
mentioned elsewhere herein:
- 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;
- 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;
- 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,
- Other specific risks that may be alluded to in this
report.
Investor Relations Contact:
Hayden IRJames
Carbonara(646)-755-7412james@haydenir.com
1 2015-Freedman et al-The Economics of Reproducibility in
Preclinical Research; PLOS Biology DOI:10.1371/journal.pbio.1002165
June 9, 2015
2 Endpoint News, June 8, 2020;
https://endpts.com/sp/48-billion-is-lost-to-avoidable-experiment-expenditure-every-year/
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