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QIMR Berghofer-developed immunotherapy for multiple sclerosis gets green light from US FDA to proceed with patient enrolment at US sites for global Phase 1 clinical study

A cellular immunotherapy treatment for multiple sclerosis, which was developed and manufactured at Brisbane’s QIMR Berghofer Medical Research Institute, has been given regulatory approval to enter into clinical trials in the United States.

The treatment was developed by QIMR Berghofer immunologist Professor Rajiv Khanna and is being manufactured at the Institute’s cell therapy manufacturing facility, Q-Gen Cell Therapeutics. The technology has been licenced by US-based biopharmaceutical company Atara Biotherapeutics, Inc.

The US Food and Drug Administration (FDA) has given Atara clearance to proceed with enrolling patients with progressive or relapsing-remitting multiple sclerosis in Phase I clinical trials in the US.

QIMR Berghofer’s Director and CEO, Professor Frank Gannon, said the decision was a major endorsement of Q-Gen Cell Therapeutics and Professor Khanna’s work.

“Q-Gen Cell Therapeutics will continue to manufacture the cellular treatments for Atara’s trial,” Professor Gannon said.

“The fact the US FDA has given approval for products manufactured at Q-Gen to enter into clinical trials demonstrates that their standards are world-class.

“I am delighted that a product developed and manufactured here at QIMR Berghofer has received approval to enter into an international clinical trial.”

The treatment uses healthy donor immune cells to selectively target Epstein-Barr virus (EBV)-infected B cells, which are believed to play an important role in the development of MS.

Last year, Atara was given approval by Australia’s Therapeutic Goods Administration (TGA) to initiate the clinical trial in Australia.

The trial is expected to enrol a total of 60 patients across the US, Australia and Europe.

Professor Khanna said the latest announcement showed that Brisbane was an internationally significant site for biotechnology and innovation.

“The research and intellectual property behind this treatment was developed here in Brisbane,” he said.

“We are very pleased that Atara has been given the green light to trial this product in patients and hope that it will lead to an improvement in their symptoms.”