Gallus BioPharmaceuticals, LLC and Omni Bio Pharmaceutical, Inc. jointly announced finalization of a multi-stage manufacturing services agreement. The agreement includes cell line optimization, analytical development and manufacturing scale-up activities for Omni Bio's leading AAT Fc fusion protein with the goal of providing cGMP product to support animal toxicology studies and early clinical trials of the molecule. Under the agreement, Omni Bio has selected the commercially available CHOZN(R) GS Cell line as the expression system.

In addition, SAFC(R) will perform the cell line development and safety testing services, in conjunction with Gallus' overall management of the process development and manufacturing services program for Omni Bio. AAT is the most abundant circulating serine protease inhibitor in the body and an acute phase reactant. Systemic deficiency in AAT due to genetic mutations can result in debilitating liver failure and chronic lung disease such as emphysema.

Lifelong treatment with plasma-derived AAT, intravenously administered, is indicated for such patients. Recent evidence suggests that AAT plays an important role in modulating immunity, inflammation and apoptosis. AAT protects various cell types from cell death, inhibits caspases-1 and -3 activity and has been shown to be effective in a wide variety of animal models of human disease, including diabetes, graft versus host disease (rejection reactions following bone marrow or other transplantation procedures), refractory gout, myocardial infarction and inflammatory bowel disease.