SBIR-STTR Award

This Small Business Innovation Research Phase I project develops methods for the reliable control of settlement and metamorphosis of larval stages of Megathura crenulata (the giant keyhole limpet) to support the production of commercial quantities of Keyhole Limpet Hemocyanin (KLH), a unique and medically valuable marine natural product. Unlike many other prospective medical products from marine organisms, KLH is already in extensive use as an immuno-stimulant, including in over 20 KLH-based clinical trials of therapeutic vaccines. KLH is commonly produced from animals harvested from the finite and fragile natural populations of California and Northern Baja California. With the potential success of one or more of these KLH-based cancer vaccines, the commercial market for KLH could exceed $50 million and place extreme pressure on the species. The broader impacts of this research are significant to the development of new medicines and the preservation of a threatened marine species. Therapeutic vaccines are a promising new class of treatment for cancer, arthritis, and other debilitating chronic diseases; several of these vaccines rely on the proven safety and efficacy of KLH?s immuno-stimulatory properties for their therapeutic effects. Although the natural population of M. crenulata cannot sustain the quantities of KLH required for commercial vaccine products, aquaculture technology has the potential to overcome this supply constraint. Reliable methods for controlling the larval stages of the M. crenulata life cycle are the key to large-scale aquaculture, and could eliminate the biomedical industry?s dependence on wild-harvested animals for commercial KLH supplies

This Small Business Innovation Research (SBIR) Phase II project will develop methods for the control of larval settlement, metamorphosis and postlarval growth of Megathura crenulata (keyhole limpet) to support the production of commercial quantities of Keyhole Limpet Hemocyanin (KLH), a unique and medically valuable marine natural product. Unlike many other prospective medical products from marine organisms, KLH is already in extensive use in over 20 KLH-based therapeutic vaccine trials. Phase I research successfully identified a critical "cue" for settlement of M. crenulata larvae and demonstrated the feasibility of achieving the long-term commercial objectives of this research. Phase II studies will translate the results from Phase I studies into prototype designs for testing and optimization of systems, diets and aquaculture methods for cultivation of the age-specific developmental phases, from metamorphosis to fully developed adults for KLH production. The broader impacts of this research are; 1) The elucidation of the underlying biochemical factors that promote settlement, metamorphosis and early postlarval survival of this carnivorous gastropod thus adding significantly to the body of scientific knowledge in this field and improving the potential for cultivation of other commercially important species with biomedical potential; 2) Providing sustainable commercial supplies of KLH for new, life-saving therapeutic vaccines for cancer, arthritis, hypertension, and other debilitating diseases, without continued dependence on the limited and threatened fishery, and; 3) Providing regulators and resource managers the opportunity to formulate management policies to protect the wild population without imposing limitations on KLH or the important KLH-based vaccines under development