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Stellar, Amaran Enter Manufacturing Pact

By Kristin Brooks

Published December 13, 2013
Related Searches: Phase I Manufacturing Development Phase II
Stellar Biotechnologies, Inc. has entered into a collaboration agreement with Amaran Biotechnology, Inc., to develop and evaluate methods for the manufacture of OBI-822 active immunotherapy using Stellar's GMP grade Keyhole Limpet Hemocyanin (KLH).
OBI-822 is an active immunotherapy combining Globo-H, a carbohydrate antigen frequently expressed by cancer cells, together with KLH as the immune-stimulating carrier molecule. OBI-822 is currently being evaluated for the treatment of metastatic breast cancer in Phase II/III trials in the U.S., Taiwan, South Korea, India and Hong Kong. It’s also being evaluated for the treatment of ovarian cancer in a Phase I/II trial in Taiwan.
Stellar will be responsible for the production and delivery of GMP grade KLH for evaluation as a carrier molecule in OBI-822 immunotherapy, as well as method development, product formulation, and process qualification for certain KLH reference standards. Amaran will be responsible for development and product specifications. Stellar will receive payment for certain expenses and costs associated with the development program. The companies may also negotiate a commercial supply agreement for Stellar KLH in the future.
"This is an important, multinational clinical project and Stellar is very pleased to collaborate with Amaran on the manufacture of Immunotherapies such as OBI-822," said Frank Oakes, president and chief executive officer of Stellar Biotechnologies. "This is an excellent example of Stellar KLH technology serving as a platform for partnerships with long-term product development and commercial potential."

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