Stellar Biotechnologies inked a collaboration agreement with Taiwan-based Amaran Biotechnology to develop methods for the manufacture of OBI-822—the lead immunotherapy product of OBI Pharma—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, according to Stellar. The compound is currently being evaluated for the treatment of metastatic breast cancer in Phase II/III 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 II/III trial in Taiwan.
As part 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.
Amaran agreed to pay Stellar fees for certain expenses and costs associated with the development program. The collaboration also provides for the companies to negotiate a commercial supply agreement for Stellar KLH™ in the future.
This is yet another immunotherapy deal for the Port Hueneme, CA-based firm. In July, through an exclusive worldwide licensing agreement, Stellar gained access to patented technology for the development of human immunotherapies against Clostridium difficile infection, developed by investigators at the University of Guelph.
