By: Dylan Sikes - AllPennyStocks.com News

Tuesday, March 19, 2013

There’s no shortage of articles on the web on biotechnology at any given point, but with recent commentary by the U.S. Food and Drug Administration about expediting drug development for areas of great unmet medical need, discussions about cannabinoids in medical marijuana now that many states are legalizing the drug with developments, the maturation of stem cell technologies and more, biotech information and speculation is probably more prominent now than ever before. An area that still holds a great deal of promise that has slipped a bit from investor attention lately is that of immunology and therapeutic vaccines. There’s plenty going on in the sector, including ImmunoGen, Inc.’s (Nasdaq:IMGN) Targeted Antibody Payload, or “TAP” technology that is used in Roche’s (OTCQX:RHHBY) recently FDA-approved breast cancer drug Kadcyla and Immunomedics, Inc.’s (Nasdaq:IMMU) pivotal study of Epratuzumab for lupus to name just a few.

A small, behind the scenes company is Stellar Biotechnologies, Inc. (TSX-Venture:KLH) (OTCQB:SBOTF) that could have an ImmunoGen/Kadcyla-type of a moment some day with its technology. The dually-listed company, headquartered in Port Hueneme, California, is a specialist in Keyhole Limpet Hemocyanin, also called KLH, derived from a rare sea mollusk which has proven potent –and safe – in humans and potentially a game changer for Stellar in several indications if it gets married with a blockbuster drug.

KLH is a large protein that carries oxygen in limpet blood and contains several epitopes that trigger the body to produce antibodies. If certain cancer markers are attached to KLH, it can stimulate the immune system to destroy them, principally part of the foundation of immunology that explains cancer cells are overlooked because the body believes they are supposed to be there. As a conjugated antigen, KLH “teaches” the body to destroy the tumor.

To that end, Stellar is the only company that employs a proprietary aquaculture technology to grow Keyhole Limpets (scarce, snail-like creatures) for their KLH protein, which can be used as a key component in conjugate vaccines targeting a variety of indications such as cancer and autoimmune disease. KLH can also be used as an antigen as a barometer of health of the immune system.

As it stands now, Stellar looks like a typical developmental biotech with small amounts of revenue (most of it coming from grants) and a net loss, but as the company noted today it is keeping its Biologics Master File with the Food and Drug Administration updated for controlled access by clients as part of product applications. This detailed dossier is intended to support Stellar's KLH customers who file applications under the Center for Biologics Evaluation and Research division, thus expanding applicability of the Stellar's KLH for broader uses. It is this technology, control commitment to help customers maneuver down the regulatory pathway that could lead to solid partnerships and an increased client portfolio (and subsequent revenue streams) for Stellar.

"Stellar is always looking for effective ways to support our customers' applications through the regulatory process," commented Catherine Brisson, Chief Pharmaceutical Officer at Stellar Biotechnologies. "By ensuring that the information required by FDA is accessible, we can facilitate regulatory approvals for KLH-based products."

Shares of KLH are ahead in Tuesday trading by about 3 percent at 61 cents halfway through the session and are up about 52 percent in the last 12 months.

Proper due diligence is, as always, encouraged.

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