SBIR and STTR Success Story for
Stellar Biotechnologies, Inc.

(Information Posted/Updated on 01/13/2004)

Stellar Biotechnologies, Inc.
417 E. Hueneme Rd. #170
Port Hueneme, CA  93401

Contact:    Frank R. Oakes
Phone:      805-488-2147
Fax:          805- 488-2147

Project Title:  Technology for Culture of Megathura Crenulata for KLH
Related Award(s):  R43 RR14937, R44 RR14937
Technology Developed:
Stellar Biotechnologies has successfully developed, optimized and demonstrated the first dedicated aquaculture technologies and non-lethal hemocyanin extraction methods for commercial scale production of keyhole limpet hemocyanin (KLH) from Megathura crenulata (the giant keyhole limpet) for biomedical applications. As part of our Phase 1 SBIR grant from the National Center for Research Resources, we successfully demonstrated that it is feasible to apply controlled-environment aquaculture technology to spawn and grow Megathura in captivity, and furthermore that these proprietary aquaculture technologies could support the sustained production of KLH for biopharmaceutical applications. In Phase II, we developed commercial-scale aquaculture systems and methods which were used to produce a controlled, sustainable, and highly reproducible supply of high quality crude KLH from animals grown in aquaculture.

Key Words:  KLH, hemocyanin, Megathura, Limpet, cancer, vaccine, aquaculture, immunostimulatory.
Uses of Technology/Products/Service:
KLH has a long history of biomedical use as an immune potentiating molecule and carrier protein to which haptens and other poorly immunogenic molecules are conjugated to increase immunogenicity via recruitment of T helper cells. The current applications for KLH include a wide variety of promising experimental vaccines, including vaccines for the treatment of cancers, chemical dependencies and infectious diseases, and for immunological control of reproductive hormones. Among the most promising current applications for KLH are anti-idiotype and other tumor-associated antigen vaccines for the treatment of lymphomas and solid tumors. The technology developed through this SBIR grant will enable the controlled and sustained production of commercial quantities of this medically valuable immunostimulatory protein from a renewable aquaculture source. KLH, which is a high molecular weight marine natural product protein, has previously only been obtainable by lethal ex-sanguination of the marine mollusc Megathura crenulata. Prior to the successful completion of this SBIR project, the potential for commercialization of KLH-based therapeutic products was greatly constrained due to dependence upon the variable, limited and potentially threatened wild population of animals. Additionally, the lack of control and potential for adventitious contamination of zoonotic products derived from wild sources has made the regulatory approval of KLH-based products from wild animals increasingly more difficult. With the success of this SBIR project, KLH is now available in commercial quantities from a fully controlled aquaculture source. Our proprietary, non-lethal methods are harmless to the source animals and proven to maintain the highest possible quality and reproducibility of the finished product. These innovations will assure a reliable supply of safe, medical-grade KLH for better vaccine discovery, development, and commercialization to the benefit of cancer patients, researchers, and clinicians worldwide.

Benefit to Company:
The financial support from the NCRR’s SBIR program has provided a critical financial bridge between the initial development and subsequent commercial demonstration of our aquaculture technology for KLH production. Despite a clear need for our technology and product by several biopharmaceutical companies, the technology was thought to be too specialized and costly to justify direct capitalization by strategic partners. The continuity of support provided by the SBIR program allowed our company to negotiate future supply agreements with prospective customers during the demonstration of the commercial feasibility of the technology, thus facilitating both development and future commercialization of the needed technology. The SBIR support also allowed the company to acquire and train technical staff and dedicate specialized facilities required for KLH production operations.

How Product Was Commercialized:
Early commercialization of the KLH product resulting from the successful completion of this project has been accomplished through the formation of strategic alliances and/or supply agreements with biopharmaceutical companies currently developing KLH-based vaccine products. Stellar identified a least six companies with KLH-based cancer vaccine products in late-stage clinical trials and has already negotiated KLH supply agreements with two of these companies. The commercialization strategy embodied in these supply agreements, offers our commercial partners: 1. A guaranteed minimum supply of KLH to meet the partner’s requirements during clinical trials and Biologics License Application (BLA) approval. 2. Guaranteed production capacity to meet the commercial demand at the level forecasted after BLA approval. 3. An established price structure acceptable to both parties based on product specifications and demand estimates for the post-BLA approval period. 4. Guaranteed minimum purchase quantities sufficient to meet Stellar’s operating costs and overhead, as required, to support the guaranteed capacity. 5. Acceptable provisions for early termination in the event of the failure to obtain BLA approval.

Through this formula Stellar expects to continue to provide a supply of crude KLH sufficient to support the current demand of researchers and clinicians, both in the private sector as well as within the multi-categorical institutes of the NIH, with scalability to meet demand during commercialization