Stellar Biotechnologies enjoys being in an enviable position where the company is able to satisfy the biopharma sector’s growing needs for a widely-used and increasingly essential immune-stimulating protein, Keyhole Limpet Hemocyanin (KLH), thanks to the company’s patented sustainable manufacturing/extraction process.
This exceptionally valuable large molecule natural protein (multisubunit, oxygen carrying) comes solely from the rare Giant Keyhole Limpet’s circulatory system (hemolymph), a marine mollusk that lives only in the coastal waters off California that stretch from Monterey Bay to Isla Asuncion off of Baja. An endangered habitat in many respects for what is such a rare creature, and thus the significance of SBOTF’s sustainable manufacturing process comes into sharp focus over the increasingly vital immune-stimulating protein they produce. KLH cuts across almost all lines in therapeutic and diagnostic applications as well, being used both as an API in novel immunotherapies ranging from cancer and infectious diseases, to immune disorders, and as an immunological measuring tool for gauging the status of a patient’s immune system. KLH is indisputably necessary to the biopharma industry, yet only Stellar possesses the capacity through their proprietary methods, facilities and KLH technology, to supply the future needs of the industry for GMP-grade KLH.
Extremely high barriers to entry exist for competitors as well and this fact, in conjunction with the over eight years of work and upwards of $20M ($7M in NIH/NSF grants and another $23M in equity funding) invested by Stellar, collectively places SBOTF shareholders in a position as unique as the Keyhole Limpet itself. A position where shareholders are now poised to reap the rich rewards of the company’s strong IP position and multiple high-margin commercial (as well as clinical) pathways for Stellar KLH™. Stellar KLH Protein, in combination with the company’s ELISA Test Kits for Immune Function Testing, demonstrate the full range of this technology’s potential, yielding optimal control and consistency in TDAR applications, a standard benchmark model for determining competent immune function. Stellar has also recently managed to secure $12M in financing (including $5M from a major bipharma investor) via private placement (Sept 23) for developing their product line, enhancing their aquaculture and KLH production, as well as broader capital expenditures. Given the scalable nature of the company’s GMP manufacturing facility, which currently can do about 1kg/year of KLH, investors will likely be flocking to SBOTF as the underlying market forces advance.
There is already an impressive amount of molecular biology research done in this area but the potential future impact across the board in immunology, immunotoxicology, and vaccine development for KLH is truly unquantifiable. More importantly, KLH is prized for its combination of immune-stimulating potency and yet general tolerability, a tolerability that is attributable to the specific characteristics (unusual glycosylation, an enzymatic process involving KLH’s unique carbohydrate moieties, something which makes KLH almost impossible to synthesize effectively) of this exceptionally large-molecule metalloprotein and its natural origin. Rapid growth in immunotherapies and immunodiagnostics is generating unprecedented demand for KLH, and Stellar is the only show in town really geared up to capture that demand as the sole worldwide producer of fully-traceable (for use in human vaccine products) GMP-grade KLH, manufactured to exacting standards thanks to SBOTF’s ground-breaking aquaculture work that has revolutionized how KLH is produced.
The company’s recent acquisition of an exclusive worldwide license for active immunotherapy technology targeting the treatment of Clostridium difficile infection (C. diff, can create life-threatening problems), which often crops up in patient’s guts after they have been treated with antibiotics (especially for severe infections using strong, broad-spectrum antibiotics), has now been examined, producing solid preclinical results that the company has subsequently showcased at two key scientific conferences. The study showed that vaccination with a PSII-KLH conjugate vaccine did indeed confer a level of immunization against C. diff infection, directly measured by survival rate of the mice in the study against their unvaccinated control group. The study also provided conclusive preclinical proof that the C. diff PSII-KLH immunotherapy approach is very safe, in addition to being effective. The company is presenting their data at the 6th Annual LD Micro Conference in Los Angeles today as well, where they are showing off their recent research results and corporate milestones to the typically over 1k attendees that come to get a closer look every year at undervalued up-and-comers in the micro-cap space.
Huge players in the game like GSK are now doing KLH active immune therapy trials for indications like Alzheimer’s. Bayer is doing autologous vaccine work in non-Hodgkin’s lymphoma and Taiwain-based OBI is doing later stage Breast Cancer work. With major research institutions and private companies also working on KLH active immune therapy trials in various cancers and tumors, the future is indeed bright for SBOTF’s compelling product line, whether its multivalent adjuvants, vaccine carriers, or end-point testing products for evaluating immune function.
The rapid advancement of the company’s strategic initiative with C. diff immunotherapy is telling of SBOTF’s unquenchable ambition and with related death/morbidity rates in hospitals increasing, KLH could become the adjuvant of choice for new oncology vaccines while simultaneously addressing primary and secondary C. diff infection problems on a global scale. Needless to say, SBOTF is really turning heads in the biopharma space recently and investors should keep a close eye on the company as they advance their C. diff platform in particular.
For more information on Stellar Biotechnologies, visit www.StellarBiotechnologies.com
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