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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