FDA approves clinical trial for QIMR Berghofer-developed immunotherapy

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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 clinical trials in the US.

The treatment was developed by QIMR Berghofer immunologist Professor Rajiv Khanna. It 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.

The US FDA has given Atara clearance to proceed with enrolling patients with progressive or relapsing-remitting multiple sclerosis in Phase 1 clinical trials based 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,” said Professor Gannon.

“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.

Atara was given approval by Australia’s TGA last year to initiate a local clinical trial.