Stellar Biotechnologies, Inc. has announced that it 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”).
Amaran designs, develops, and manufactures active immunotherapies such as OBI-822, the lead immunotherapy product of OBI Pharma, Inc. The primary purpose of the alliance is to develop and evaluate methods for the manufacture of the OBI-822 active immunotherapy using Stellar’s GMP grade KLH.
OBI-822 is a new generation of active immunotherapy combining Globo-H, a carbohydrate antigen frequently expressed by cancer cells, together with KLH as the immune-stimulating carrier molecule. An active immunotherapy uses a patient’s own immune system to recognize and mount an attack against the targeted tumor cells.
OBI-822 is currently being evaluated for the treatment of metastatic breast cancer in International Phase 2/3 clinical trials in the United States, Taiwan, South Korea, India and Hong Kong. It is also being evaluated for the treatment of ovarian cancer in an investigator-initiated Phase 1/2 clinical trial in Taiwan.
“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 CEO of Stellar Biotechnologies, Inc. “This is an excellent example of Stellar KLH™ technology serving as a platform for partnerships with long-term product development and commercial potential.”
Catherine Brisson, Ph.D., Chief Operating Officer for Stellar said, “KLH is a key active ingredient in immunotherapy drugs. Our goal is to ensure that partners such as Amaran have future supply of the highest-quality KLH to meet the specifications of each particular immunotherapy drug.”
“We are pleased to have Stellar Biotechnologies’ key technical advances in KLH applied to this important cancer active immunotherapy program,” said Tessie Che, General Manager and Chair of Amaran’s Board of Directors. “We look forward to working closely with the Stellar team on this development project.”
Under the terms of the agreement, Stellar will be responsible for the production and delivery of GMP grade KLH for evaluation as a carrier molecule in OBI-822 immunotherapy. Stellar will also be responsible for method development, product formulation, and process qualification for certain KLH reference standards. Amaran will be responsible for development objectives and product specifications.
The agreement provides for Amaran to pay to Stellar fees for certain expenses and costs associated with the development program.
Subject to certain conditions and timing, the collaboration also provides for the companies to negotiate a commercial supply agreement for Stellar KLH™ in the future.