Stellar Biotechnologies, Inc. Wins $3 Million NCI Award for KLH Development.

PORT HUENEME, Calif. -- Stellar Biotechnologies, Inc. of Port Hueneme, CA, today announced that it has been awarded $3 million from the National Cancer Institute of the National Institutes of Health for the development of production methods, quality standards, and facilities for the commercialization of Keyhole Limpet Hemocyanin (KLH) for use in anti-cancer vaccines. The award is a competing continuation of a Small Business Innovative Research (SBIR) Phase II grant previously awarded to the company for the development of aquaculture technology for Megathura crenulata (the source animal for KLH) and is funded through the NCI's FLAIR (Flexible System to Advance Innovative Research) program for small businesses.

KLH is a highly immunogenic, T cell-dependent protein used as a vaccine platform or "carrier" molecule for vaccine antigens. By combining KLH with tumor-associated antigens, anti-cancer vaccines are formulated to overcome the immune system's tolerance of "self" antigens, resulting in robust immunological anti-tumor responses.

The NCI grant will support the development and manufacture of refined formulations of KLH which are in demand as critical components of several commercial experimental cancer vaccines that are undergoing late-stage clinical trial evaluations. Cancer vaccines are at the forefront of new immunological therapies for cancer, and KLH-based vaccines now in advanced clinical trials are showing promise against lymphoma, breast, colon and other cancers.

"We are grateful for the strong support that the National Institutes of Health and the National Cancer Institute have shown for our commercial KLH program," said David Spaulding, Ph.D., CEO and Chief Scientific Officer of Stellar. "This competitive award directly addresses the growing need for a dependable commercial source of medical-grade KLH for the rapidly developing field of cancer vaccines, and validates Stellar's commercialization plan for this unique vaccine platform. The KLH molecule confers potent immunogenicity to carbohydrates, peptides, and many other types of small molecules, and holds significant potential for a wide range of therapeutic and preventative vaccine applications in addition to cancer."

Stellar Biotechnologies, Inc., of Port Hueneme, CA, is a privately held biopharmaceutical supply company dedicated to the development and production of commercial-scale KLH products for the vaccine industry. The company applies its proprietary technologies and expertise in commercial aquaculture systems, molluscan reproductive biology, and biomolecule purification to the production of KLH under GMP (Good Manufacturing Practices) from captive Megathura crenulata.