SBIR Phase I: Megathura crenulata Post Larval Culture - Bottleneck for a Valuable Medical Resource

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.