Patheon and Sigma-Aldrich Fine Chemicals (SAFC) have reached a milestone for their development partner, Omni Bio Pharmaceutical, Inc. The two companies have successfully identified several high-expression cell lines able to produce Omni Bio’s novel recombinant alpha-1 antitrypsin molecule (AAT-Fc) in large enough quantities to be considered commercially viable.
This is a highly significant de-risking milestone that enables Omni Bio to move toward IND-enabling toxicology studies with the first and only pharmaceutically feasible recombinant AAT candidate currently in development. Omni Bio is an emerging biopharma focused on revolutionizing the treatment of immune-mediated inflammatory diseases.
Ten candidate cell lines have been selected for further characterization based on their ability to achieve economically attractive AAT-Fc yields. The best performing cell line is expected to move into manufacturing scale-up activities in early 2015 to support further preclinical investigations and early clinical studies.
Bruce Schneider, Ph.D., Omni Bio’s Chief Executive Officer, stated, “On behalf of Omni Bio and our manufacturing partners, we are thrilled to achieve this critical milestone. This achievement sets us apart from other companies that have attempted and failed to produce a recombinant AAT molecule in a pharmaceutically appropriate form. Our Fc fusion technology not only enables scalable manufacturing of this novel product candidate, but also offers the promise of significantly improved potency, longer duration of action and patient-friendly subcutaneous dosing compared to current plasma-derived AAT products. We have now set the stage for the testing of AAT-Fc in various immune-mediated inflammatory diseases, including but not limited to Type 1 diabetes, graft-versus-host disease and chronic gout.”
Having achieved this important value inflection point, Omni Bio has engaged Destum Partners, Inc. (Destum), a biopharma and life sciences-focused advisory firm, to assist the company in securing a strategic partner for advancement of AAT-Fc. The company’s goal is to license rights to develop and commercialize AAT-Fc, and certain other intellectual property, as a means of infusing Omni Bio with non-dilutive capital to fuel ongoing operating activities.
Dr. Schneider concluded, “Destum’s results-oriented track record in pharmaceutical business development is impressive. With a key development hurdle for AAT-Fc now overcome, we look forward to working closely with them to identify one or more partners who can help us accelerate our efforts to bring our AAT-Fc treatment candidate to patients.”
Patheon is a Founding Member of the Pharma & Biopharma Outsourcing Association.