Stellar has rapidly secured access to a key area of the burgeoning biomedical space through the development and patenting of a renewable method for extraction of KLH, or Keyhole Limpet Hemocyanin (complex oxygen-carrying metalloprotein), a vitally important and highly potent protein. KLH is derived only from the giant keyhole limpet, a kind of sea snail that lives only in the coastal waters off California. Stellar KLH™ Protein is a lucrative product with enormous potential and noteworthy market dynamics.
Stellar has the sole, crucial patent for extraction of this renewable resource and recently (Dec 4) moved to further reinforce their strong IP foundation by filing a patent application on the suKLH technology platform that included composition of matter and usages in a wide range of therapies, as well as manufacturing processes used to farm these limpets in aquaculture. Stellar really has mastered an environmentally sound, non-lethal derivation of pharmaceutical grade (GMP-grade) KLH from the little guys. It is a truly inspiring feat of modern science that blends nature with high-tech. The company is in a leadership position here with the top high molecular weight (hmwKLH) and subunit KLH (suKLH) formulations, with the suKLH formulation's show-stopping immunogenic potency giving the company a serious edge.
Such high-quality, maximum potency vectors as those in the company's KLH formulations allow developers to forego incorporation of otherwise dangerous adjuvants (with harmful side-effects) in order to beef up overall immunogenicity in vaccine research. Stellar is positioned to push huge shareholder return numbers due to KLH being critical to over a hundred current clinical trials in bonanza sectors like Alzheimer's, rheumatoid arthritis, autoimmune disorders, and oncology where, collectively, the net sum quality of life result for millions of people is unquantifiable. The kind of end market territory in therapeutic vaccines and immune testing we are talking about here is incredible, and there is considerable space to develop in KLH-based assays as well, with the company's Anti-KLH ELISA Test Kits (launched in early April), already showing solid traction in drug screening. It's a prime example of how this technology can deliver an extremely robust test framework for judging a drug candidate's capacity for immune system regulation.
This key immunostimulus function of KLH has made it a de facto standard as an antigen among researchers looking to push the envelope of clinical development while retaining high tolerability/safety. Major advances in immune diagnostic testing, like T-cell-dependent antibody response (TDAR, the standard immune competency benchmark for regulators and drug developers), are making KLH look more and more like a sure-fire solution for providing a clinical, trial-ready, standalone injectable for Big Pharma developers.
There are only two other manufacturers in the world for this stuff and it is virtually impossible to synthesize due to the size and complexity of the molecule. The first of those manufacturers, Sigma Aldrich, is dependent on Stellar KLH intermediate as their sole supplier. The second, a German neutricuetical firm named Biosyn (runs a CA-based subsidiary), only produces a specialized suKLH formulation (admittedly failing to produce a potent antibody response and requiring an adjuvant) developed for their own bladder cancer technology, thus any kind of real competition is virtually nil. Stellar has all the ground work laid for capturing the growing range of pharmaceutical KLH applications, and they are ready to go with land-based, scalable aquaculture farming and manufacturing, as well as the IP muscle to back this play.
The value of the company's KLH formulations from a clinical immune-toxicity testing standpoint are particularly good, and with over a decade of research as well as $16M invested in the technology (half from the company and half from the National Institutes of Health and National Science Foundation), SBOTF today stands behind an extensive trade secret/patents pending IP portfolio that covers the U.S., Canada, France, and Germany. With the only real challenger being the German firm Biosyn and an increasingly stringent stance from FDA and EU regulators on biologicals/viral safety, the long track record for safety of the molecule combines with the company's established reputation for superior formulation to generate a strong headwind for the Stellar Biotech ship.
The company is basically its own supplier of limpets as well, with the animal population thoroughly cultivated by SBOTF personnel at their land-based facility in Port Hueneme (under license from the US Navy and fully permitted by all relevant regulatory bodies) and any additional requirements satisfied by company divers or business relationships. Stellar can even help pharmaceutical and research clients with custom solutions via their Stellar Business Development unit, providing everything from custom assays and formulations for a specific project, to regulatory dossier support and the development of protocols or reference standards. Full access to the company's 30-plus years of KLH-related biochemistry and technical expertise is offered as SBOTF actively seeks partnerships that can help exploit the maximum vaccine/immunodiagnostics development potential of the technology pipeline.
Current production capacity roughly exceeds all other commercial capacity and is around upwards of 800g GMP suKLH annually (1.5 Kg of starter material), with a 233% increase in annual output capacity (5Kg) on-track for the next four years, and scalability up to 20 to 100 Kg over the next seven to eight years within striking distance if demand continues to be high. Stellar signed mutual NDAs with seven of the fifteen largest biopharma developers this year and is set to pop as the company continues to draw increased attention from Big Pharma/Biotech concerns.
To learn more about Stellar Biotechnologies, visit StellarBiotechnologies.com
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