Cell Therapies Pty Ltd (CTPL) has been engaged by Germany-based biopharmaceutical company BioNTech SE (BioNTech) to manufacture BioNTech’s novel CAR-T cell therapy candidate BNT211 in Australia. The candidate is an investigational treatment for cancer patients with relapsed or refractory advanced solid tumours, currently part of a BioNTech-sponsored global Phase 1/2 clinical trial.
Under the agreement, CTPL will establish a clinical trial product supply chain in Australia for BioNTech and its BNT211 development program, utilising its extensive CAR-T manufacturing experience.
Cell Therapies Chief Executive, Peter Giannopoulos, said “CTPL is a world-leading commercial contract development and manufacturing organisation based in Melbourne, Australia and is co-located with the Peter MacCallum Cancer Centre.”
“As the first Australian site to obtain TGA approval for the manufacture of CAR-T cell therapy products, we are delighted to be working with an innovative company like BioNTech,” Mr Giannopoulos said. “We look forward to using our onshore manufacturing and development capabilities to support BioNTech.”
Cell Therapies Chief Scientific Officer, Associate Professor Dominic Wall, stated “Our strong regulatory compliance and deep history with CAR-T products, as well as our accredited facilities and staff, means we are perfectly placed to work with BioNTech to manufacture this product candidate in Australia.”