Benitec Biopharma has announced an agreement with US-based Omnia Biologics to manufacture clinical material for the current first-in-man clinical trial of TT-034, a potential ‘one-shot’ cure for hepatitis C.
According to Dr Claudia Kloth, Benitec’s US-based Vice-President of Manufacturing, “Omnia has a well established manufacturing process for Adeno-Associated Virus (AAV)-based products that is comparable to the one used to produce the material currently used for the TT-034 trial. This supply agreement ensures that we have sufficient clinical material to complete the current trial.”
The company recently announced the extension of its dose escalation clinical trial of TT-034. TT-034 is a ddRNAi-based therapeutic, designed to treat and potentially cure HCV with a single administration.
“Whilst the process used for manufacturing clinical material in the TT-034 Phase I/IIa clinical trial is adequate for our immediate requirements, the process is not scalable," said Benitec CEO, Dr Peter French. "Therefore, to supply the large markets Benitec is aiming for such as in hepatitis C and B, the Company is moving to establish its own large-scale manufacturing process in collaboration with third parties, and we will make further announcements about those developments as they occur.”
No financial details of the Omnia agreement were disclosed.