Stellar Biotechnologies, Inc. and Amaran Biotechnology Inc. Provide Update on Collaboration
Oct 1 15
Stellar Biotechnologies, Inc. provided an update on the company's ongoing collaboration with Amaran Biotechnology, Inc. The alliance between Stellar and Amaran was formed in 2013 to develop and evaluate methods for the manufacture of the OBI-822 immunotherapy, which incorporates Stellar KLHTM as the immune-stimulating carrier molecule. Stellar and Amaran have now completed all primary objectives of the collaboration, which include method development, formulation, and process qualification for GMP-grade Stellar KLHTM and meeting the specifications needed for the production of OBI-822. The next stage of the collaboration will involve scale-up and optimization of processes to commercial manufacturing levels, with the focus on production, quality, and regulatory requirements to support OBI Pharma's planned global Phase III trial and potential future market launch.
Stellar Biotechnologies Announces Collaboration with Amaran Biotechnology, Inc
Dec 12 13
Stellar Biotechnologies, Inc. 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. 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. 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(TM) in the future.