Arovella Therapeutics Ltd (ASX:ALA) has inked a services agreement with the cell therapy manufacturing arm of QIMR Berghofer Medical Research Institute, paving the way to produce its invariant Natural Killer T (iNKT) cell therapy for clinical trials.
The biotech stock’s cell platform is designed to treat blood cancers and its first investigative CAR19-iNKT cell therapy candidate, known as ALA-101, is off to the factory.
QMIR’s Q-Gen Cell Therapeutics arm will manufacture the ALA-101 treatment candidate for the clinical trials — the company can generate cellular immunotherapies for patients in Australia, Asia, the United States and Europe.
Speaking to the agreement, Arovella said streamlining manufacturing was a critical step to kick off clinical trials for its lead product to treat CD19-producing leukemias and lymphomas.
Developing off-the-shelf cell therapy
Arovella CEO and managing director Dr Michael Baker said the company was delighted to commence its partnership with Q-Gen.
“We are looking forward to manufacturing our novel CAR19-iNKT cell therapy to treat cancer patients,” he stated.
“We see the development of an off-the-shelf product as an essential step forward for the cell therapy field.”
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 unlike the FDA approved autologous CAR-T cell therapies.
The company expects this to make the therapy potentially more readily available, more affordable and will enable it to reach more cancer patients.
About Q-Gen
Q-Gen was established in 2002 to support clinical translation and discoveries made by researchers at the QMIR institute.
Nowadays, the company’s facility manufactures for academic and biopharmaceutical partners, both nationally and internationally.
Q-Gen is also accredited by Australia’s Therapeutic Goods Administration as a Good Manufacturing Practice (GMP) facility.
In the past, the company has produced autologous and allogenic cell therapy products for clinical trials.
Speaking to the services agreement, 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.”
A deeper look
Today’s services agreement is effective immediately and is expected to conclude in FY22, but it’s anticipated to be followed by a master manufacturing services agreement.
The proposed services agreement will allow Arovella to begin to work with Q-Gen to manufacture its ALA-101 candidate for later-stage clinical trials.
As is usual, normal commercial cancellation provisions apply to the services agreement, while the overall costs are not considered material and are included in Arovella’s existing budgets and funding.
Both parties retain their own intellectual property (IP) and IP created under the services agreement will vest with Arovella, unless created solely by QIMR Berghofer, who will retain such IP.