Australian biotechnology company Benitec Biopharma has signed an agreement with US-based Omnia Biologics to manufacture clinical material for the current first-in-man clinical trial of TT-034 – a ddRNAi-based therapeutic designed to treat and potentially cure Hepatitis C (HCV) with a single administration.
“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,” said Dr Claudia Kloth, Benitec’s US-based Vice-President of Manufacturing.
“This supply agreement ensures that we have sufficient clinical material to complete the current trial.”
Benitec’s CEO, Dr Peter French, said Benitec was working to establish scalable manufacturing process with third parties.
“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,” Mr French said.
“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.”
Benitec did not disclose the financial details of the Omnia agreement in the ASX announcement issued on Tuesday.
TT-034 is a potential “one-shot” cure for hepatitis C, which targets the hepatitis C viral RNA at three separate, highly conserved sites and acts as a “triple therapy” even though it is a monotherapy. This allows it to minimise the ability of the virus to mutate and escape the therapy.
The therapeutic has been extensively tested in pre-clinical in vivo studies and showed no adverse effects at any therapeutic dose. However, as it is regulated as a gene therapy, the trial design is to primarily ensure that treatment with TT-034 is safe, hence the gradual dose escalation.