SBIR-STTR Award

Technology for Culture of Megathura Crenulata for KLH
Award last edited on: 2/22/19

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$4,509,194
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Frank R Oakes

Company Information

Stellar Biotechnologies Inc

332 East Scott Street
Port Hueneme, CA 93401
Location: Single
Congr. District: 24
County: San Luis Obispo

Phase I

Contract Number: 1R43RR014937-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2000
Phase I Amount
$97,700
Development of technology is proposed for controlled reproduction and rearing of juvenile Megathura crenulata, the Giant Keyhole Limpet, for use in the production of clinical grade Keyhole Limpet Hemocyanin [KLH], an active, non-specific immunotherapeutic adjuvant used in research and treatment of certain cancers. The only existing source of KLH is from the hemolymph of wild Megathura collected through lethal exsanguination. The proposed research will use methods the investigator developed and proved effective for the domestication of Haliotis rufescens, a similar marine prosobranch gastropod, as the basis for a plan to develop the specialized technology necessary to spawn and rear Megathura in a controlled system. Preliminary results using adult Megathura grown at the company's marine culture facility have demonstrated that it is possible to produce high quality KLH from animals grown in captivity and fed specialized diets. It is expected that, with this research, a captive-breeding program can be established to produce a consistent supply of Megathura without reliance on harvest from a limited natural resource. They further propose to perfect formulated diets, identify preferred genetic stocks, and establish a breeding program to satisfy the long term demand of researchers and pharmaceutical companies seeking to develop and commercialize KLH-based therapeutic products. PROPOSED COMMERCIAL APPLICATION: The proposed research will create a reliable, environmentally friendly source of clinical grade KLH for use by pharmaceutical industry and the medical research community. Additionally, the research will create a source of live Megathura crenulata for use in the continuing effort to identify and purify new pharmaceutical compounds, and a supply of juvenile Megathura for restoration of the native population depleted by commercial harvest of the resource for KLH production.

Phase II

Contract Number: 2R44RR014937-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2001
(last award dollars: 2007)
Phase II Amount
$4,411,494

Development of technology is proposed for the controlled, commercial scale reproduction and rearing of Megathura crenulata, the Giant Keyhole Limpet, for production of Keyhole Limpet Hemocyanin (KLH), an active, non-specific immunotherapeutic adjuvant widely used in biomedical research and specifically in the treatment of certain cancers. The specific aims of Phase I were achieved by: 1) Developing a method to control spawning; 2) Developing procedures for hatching and rearing larvae through metamorphosis; 3) developing suitable diets for growing adult Megathura in captivity; and 4) demonstrating the quantity and quality of KLH from specimens grow in captivity are comparable to those measured in wild populations. In Phase II we propose to: a) Develop and optimize diets for Megathura post-larvae and sustained KLH production; b) Optimize culture methods and stage-specific aquaculture systems for long-term maintenance of KLH-producing stock suitable for commercial scale production; c) Perfect reliable commercial procedures for non-lethal extraction and purification of KLH from aquaculture stock; d) Develop Standard Operating Procedures and establish Good Manufacturing Practice (GMP) standards for KLH produced from aquaculture; and e) In conjunction with prospective Phase III partners, develop a comprehensive business plan for scale-up of our company to meet forecasted KLH demand. PROPOSED COMMERCIAL APPLICATION: The proposed research will create a reliable commercial source of clinical grade KLH for use by pharmaceutical producers and the medical research community. Additionally, the research will create a source of live Megathura crenulata for use in the continuing effort to identify and purify new pharmaceutical compounds, and a supply of juvenile Megathura for restoration of the native population depleted by commercial harvest of the resource for KLH production.