There are
four things you absolutely must know about Stellar Biotechnologies, the world
leader in the sustainable production of immunization-grade Keyhole Limpet
Hemocyanin (KLH) molecules. For those unfamiliar with KLH, it is used as an
adjuvant and protein carrier in the rapidly growing field of Immuno-Oncology
Cancer (IOC) Therapy.
1.
Reporting on the 2014 meeting of the American Society of Clinical Oncology
(ASCO), veteran biotechnology investment advisor John McCamant wrote that “the
immuno-oncology sector is primed to become a super blockbuster market. Most
current Wall Street estimates (placing) the immuno-oncology treatment space
(at) $10–$15 billion are based on only a few cancer types (melanoma, NSCLC and
renal) … but the signal at ASCO is that immuno-oncology, with all the new tools
emerging, will impact the vast majority, if not virtually all, cancer types in
some shape or form.”
2. The
peptides, small proteins and drug molecules used in cancer vaccines and other
immunological therapy agents are generally ineffective unless combined with a
carrier protein capable of stimulating an intense immune response within the
patient’s body. KLH, which generates a very powerful immune response, has
quickly become the carrier protein of choice for most IOC applications.
3. Tests
released by the National Center for Biotechnology Information show that KLH
“has significant antiproliferative effects in vitro against breast cancer,
pancreatic cancer, prostate cancer and Barrett’s esophageal cancer.” Numerous
other studies, some as recent as last year and others dating back almost a
decade, report similar findings.
4.
Historically, the best, most potent source of vaccine-grade KLH has been the
California Giant Keyhole Limpet. At the present time, Stellar Biotechnology’s
aquaculture breeding and processing center in Port Hueneme, California is
believed to be the world’s only dedicated facility for controlled spawning and
development of the limpets in a safe, non-polluted environment. The combination
limpet “incubator” and processing plant uses proprietary technology and
Stellar’s patented non-lethal extraction process to produce proteins optimized
for use as an essential part of many Immuno-Oncology therapies. The new
facility has a spawning capacity of 2 million larvae and is designed to produce
50,000 juvenile limpets per year to support the increased demand for Stellar
KLH products.
In
addition to providing KLH as an adjuvant to other pharmaceutical companies’
immunization formulas, Stellar is heavily invested in developing its own
end-to-end KLH-based therapies for specifically targeted conditions with a
limited range of current treatment alternatives.
The first
of these likely to reach market is an immunotherapy vaccine to prevent primary
and secondary Clostridium difficile (C. diff) infections, which can, according
to the Mayo Clinic, cause inflammation of the colon (colitis), patches of raw
intestinal tissue that can bleed or become infested with pus and dehydration
requiring hospitalization.
Stellar’s
anti-C. diff agents are being produced under a worldwide license giving the
company exclusive rights to develop, manufacture, and sell human C. diff
vaccines derived from patented human immunotherapies discovered at the
University of Guelph, Ontario. The license also awards Stellar similar rights
in regard to using the patents to develop and market C. diff diagnostic aids.
“This
opens significant new opportunities for Stellar and is an excellent fit in our
goal to secure complementary technologies for strategic expansion,” said Frank
R. Oakes, Stellar founder, president and CEO. “We hold the world’s leading
technology for sustainable manufacture of KLH protein and now we have a strong
platform for Stellar’s first proprietary, active immunotherapy program.”
Chief
Technology Officer Herbert Chow, Ph.D., added that research done in conjunction
with Guelph prior to the issuance of the license proved that “a PSII-KLH
conjugate has the potential to be a major infectious disease immunotherapy” and
noted that those research results plus the license “opens the door for a
multitude of new uses for Stellar KLH technology.”
SBOTF’s
corporate objectives are precise, clearly stated and well on the way to
attainment. Its strategy, the company says, is “to produce, maintain and
develop keyhole limpets through intellectual property and to continuously
advance key IP to extract, purify and formulate KLH profitably, while
increasing the number and maintaining the good health of the essential source
animals.”
Another
strategic initiative includes “marketing and selling the company’s formulations
of KLH and (making) consistent efforts to expand markets, promote the use of
KLH within the academic, research, pharmaceutical, biotech and medical
diagnostic markets, and alone and in partnership with others, develop and sell
as many proprietary KLH-based products as possible for the medical diagnostic
and therapeutic markets.”
Commenting
on Stellar’s impressive track record in achieving strategic partnerships with
other Immuno-Oncology therapy pioneers, Oakes, a 30-year aquaculture industry
veteran and developer of much of Stellar’s patented technology, noted that
“this has been an important strategic year for Stellar … our corporate
collaborations, where Stellar KLH is used as the critical carrier molecule in
new therapeutic vaccines, are strong and poised for clinical advancement.”
The list
of major stakeholders in the Immuno-Oncology space electing to become one of
Stellar’s “corporate collaborators” is both impressive and growing.
Included
is Bayer Innovation GmbH (BIG), which uses KLH as a key element in its
personalized idiotype vaccine for the treatment of Non-Hodgkin’s Lymphoma. As
part of its compensation, in addition to a cash payout, Stellar was granted an
exclusive, irrevocable worldwide sub-licensable and royalty-free license to the
technology developed through the collaboration. The license allows BIG to use
the technology in the non-Hodgkin Lymphoma vaccine under development, but
Stellar may exclusively commercialize the technology in all other applications.
Stellar is
also partnering with the French biotechnology firm Neovacs SA, a pioneer in
developing active immunotherapy solutions for autoimmune and inflammatory
diseases, to provide its KLH/SUBUNIT extract for Neovacs’ trials of new
vaccines for rheumatoid arthritis and Lupus.
Another
collaboration is an exclusive manufacturing and supply agreement under which
Life Diagnostics, a leading producer of medical testing and diagnostic kits and
reagents, will use Stellar KLH to develop and manufacture Stellar-brand test
kits for the detection of anti-KLH antibodies for use by immunotoxicity and
immunology researchers.
Stellar
has also entered into an agreement with the SAFC division of Sigma Aldrich, a
highly respected international vendor of specialty chemicals and biologics for
commercial life science applications. Under the terms of the contract, SAFC
will “sell, distribute and market” Stellar’s high molecular weight keyhole
limpet hemocyanin (HMW KLH) for application in therapeutic vaccines.
In
addition to partnering with world-class pharmaceutical companies and research
institutions, SBOTF has received research and other grants from the National
Science Foundation, the National Institute of Health’s Center for Research
Resources, the California Technology Investment Partnership and the Internal
Revenue Service’s Therapeutic Discovery Project Program.
Ranked
number one across all five industry sectors of the 2014 TSX Venture 50®, an
elite listing of top companies traded on the Toronto Stock Exchange’s sister
exchange, the TSX Venture Exchange, SBOTF’s bottom-line is showing significant
growth for a company almost obsessively invested in research and development.
Quarter-to-quarter revenues for Q3 of the 2014 fiscal year ending in August
jumped 140 percent to $102,500, while R&D spending went from $178,000 in Q3
2013 to $462,129 in 2014, largely due to development costs associated with the
C. diff vaccine manufacturing process.
According
to numerous studies published by the National Institute of Health and other
government and private research institutes, one of the greatest potential uses
of Immuno-Oncology is to help us learn how cancer bypasses the immune system
and how to create new chemical barriers to close that lethal “loophole.” With
the eventual goal the restoration of the body’s ability to rid itself of
tumors, the demand for Stellar Biotechnologies’ KHL, KLH/SUBUNIT and other
limpet-based products could potentially develop into one of those highly prized
but infrequently encountered rarities known as a virtually no-limits market.
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