IDT has announced a new agreement with Monash University under which it will provide contract manufacturing services to the Monash Institute of Pharmaceutical Sciences (MIPS) for its mRNA COVID-19 vaccine clinical trial.
The company previously undertook sterile readiness activities as provided for in the Sterile Readiness Agreement finalised between IDT and the federal Department of Health (Health).
It said these sterile readiness activities resulted in the TGA granting a sterile manufacturing licence extension. The Sterile Readiness Agreement between IDT and Health provides for an exclusivity period during which it has the exclusive option to negotiate to use IDT's sterile manufacturing facility.
The exclusivity period continues for four months from the completion of IDT's sterile readiness works. IDT has sought and received consent from Health for IDT to utilise its sterile manufacturing facility, during the exclusivity period, for the MIPS mRNA COVID-19 vaccine manufacturing activities.
The MIPS COVID-19 receptor binding domain vaccine project is funded by mRNA Victoria and the federal government's Medical Research Future Fund. It is hoped that the initial clinical trial will commence in the fourth quarter of this calendar year.
The receptor-binding domain mRNA vaccine candidate has been developed by MIPS in conjunction with The Peter Doherty Institute for Infection and Immunity. It is Australia's first locally developed COVID-19 mRNA vaccine candidate to progress to clinical trial.
Monash University president and vice-chancellor Professor Margaret Gardner AC said Monash is home to Australia's largest network of RNA and mRNA researchers.
"We are building an RNA ecosystem that will lead to the rapid development of lifesaving vaccines and therapeutic treatments for communities across the country," said Professor Gardner.
"To enable Australia to avoid ongoing issues around vaccine supply chains from other countries, we need our own mRNA production connected to research and development, and late-stage clinical trials capability.
"This partnership agreement with IDT and the ongoing support from the Victorian and Commonwealth Governments is a significant step in Australia moving towards establishing unlimited capability."
"We are very appreciative of the Australian Government's support in getting IDT's sterile manufacturing facility ready to take on a project of this nature; and for allowing IDT to utilise the facility for this work," said IDT CEO Dr David Sparling.
"We are also very appreciative of the Victorian Government's support for this project. Being Australia's first locally developed mRNA COVID-19 vaccine, all of the team here at IDT are excited to be a part of the MIPS project. It is a great opportunity for IDT to develop and showcase our cGMP manufacturing capabilities in mRNA product manufacture."
