Arovella Therapeutics (ASX:ALA) has announced it has agreed commercial terms for the initial manufacturing services agreement for its first investigative CAR19-iNKT cell therapy candidate (ALA-101) with Q-Gen Cell Therapeutics.
Arovella is focused on developing its invariant Natural Killer T (iNKT) cell platform to treat blood cancers.
Q-Gen is the cell therapy manufacturing arm of the QIMR Berghofer Medical Research Institute.
Arovella said streamlining manufacturing is a critical step to initiating clinical trials for ALA-101 to treat CD19-producing leukemias and lymphomas.
Arovella’s CAR19-iNKT cells are being developed to be used off the shelf, meaning that the therapy can be manufactured from a healthy donor, frozen and given to patients when needed, without any delay. This differentiates them from autologous CAR-T cell therapies.
Q-Gen was established in 2002 to support clinical translation and discoveries by the Institute’s researchers. It is accredited by Australia’s TGA as a Good Manufacturing Practice (GMP) facility.
Arovella CEO and managing director Dr Michael Baker said, “We are delighted to commence our partnership with Q-Gen. We are looking forward to manufacturing our novel CAR19- iNKT cell therapy to treat cancer patients. We see the development of an off-the-shelf product as essential step forward for the cell therapy field.”
Q-Gen Cell Therapeutics’ general manager Andrew Masel said, “We are excited to be working with Arovella on what we see as a unique cell therapy platform. The team at Q-Gen is looking forward to working closely with Arovella to produce the product for clinical trials.”
Arovella said the services agreement is effective immediately and is anticipated to be followed by a proposed master manufacturing services agreement.