On April 20, 2022 Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell platform to treat blood cancers, reported that it has agreed the commercial terms for the initial manufacturing Services Agreement for its first investigative CAR19-iNKT cell therapy candidate (ALA-101) with Q-Gen Cell Therapeutics (Q-Gen), the cell therapy manufacturing arm of the QIMR Berghofer Medical Research Institute (QIMR Berghofer) (Press release, , APR 20, 2022, View Source [SID1234629024]). Streamlining manufacturing is a critical step to initiate clinical trials for Arovella’s lead product, ALA-101 to treat CD19-producing leukemias and lymphomas.
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In January 2022, Arovella selected the manufacturer for its clinical grade lentiviral vector and with the selection of Q-Gen, the manufacturers are now in place to generate ALA-101 for clinical trials. 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. Arovella expects this to make the therapy potentially more readily available, more affordable and will enable it to reach more cancer patients.
Q-Gen is at the forefront of manufacturing immunotherapies and cell therapies. Established in 2002 to support clinical translation and discoveries by the Institute’s researchers, the facility now manufactures for academic and biopharmaceutical partners nationally and internationally. Q-Gen is accredited by Australia’s Therapeutic Goods Administration as a Good Manufacturing Practice (GMP) facility. The facility can produce cellular immunotherapies for patients in Australia, Asia, the United States and Europe. Q-Gen has successfully produced autologous and allogenic cell therapy products for clinical trials.
Arovella’s CEO and Managing Director, Dr Michael Baker, commented "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, commented "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."
The Services Agreement is effective immediately and is anticipated to be followed by a proposed Master Manufacturing Services Agreement. The Services Agreement is anticipated to conclude in FY2022. The proposed Services Agreement will allow Arovella to begin to work with Q-Gen to manufacture the product for later stage clinical trials. Normal commercial cancellation provisions apply to the Services Agreement. The overall costs of the services under the Services Agreement are not considered material and are included in existing budgets and funding. Both parties retain their own intellectual property (IP). IP created under the services agreement will vest with Arovella, unless created solely by QIMR Berghofer, who will retain such IP.