Arovella Therapeutics (ASX:ALA) has cemented the terms of an initial manufacturing Services Agreement (SA) with the Brisbane-based QIMR Berghofer Medical Research Institute (QIMR) to streamline Arovella’s pathway to trials for its lead ALA-101 blood cancer treatment.
The ALA-101 product will be produced by QIMR’s manufacturing arm, Q-Gen Cell Therapeutics. ALA selected Q-Gen as manufacturer in January this year. Its CAR19-iNKT product was developed at Imperial College London.
Arovella intends for its ALA-101 product to be used off-the-shelf, wherein healthy donors supply materials which are cryogenically stored and given to patients when needed.
The company notes this will circumvent delays witnessed in FDA similar approved CAR-T cell therapies for leukemias and lymphomas.
QIMR’s manufacturing arm Q-Gen was established in 2022, growing since that time into a manufacturer for academic and biopharmaceutical partners domestically and overseas.
Q-Gen is accredited by the Australian Therapeutic Goods Administration (TGA), the Australian counterpart to the US FDA.
Q-Gen’s facility is registered to send its products to Australia, parts of Asia, the US, and Europe, allowing Arovella to enjoy QIMR’s international footprint.
Q-Gen and Arovella will work towards a Master Manufacturing Services Agreement to follow the initial services agreement executed today, though, will conclude in July this year at the end of FY2022.
The proposed Master agreement will allow Arovella to commence its work with Q-Gen to manufacture the product for more rigorous late stage clinical trials in patients with blood cancer conditions.
The company considers costs attached to the services agreement to be immaterial, and are included in existing budgets and funding; meaning Arovella’s cash flow won’t take a hit.
Both parties retain respective intellectual property rights under Australian law; though, IP created under the services agreement will rest with Arovella. Unique breakthroughs developed by QIMR’s will see corresponding IP retained by the latter.
Arovella chief Dr. Michael Baker described the partnership as essential.
“We are delighted… looking forward to manufacturing our novel CAR19-iNKT cell therapy [with Q-Gen]”, Dr. Baker said.
Q-Gen Cell Therapeutics General Manager Andrew Masel echoed his partners sentiment.
“The team at Q-Gen is looking forward to working closely with Arovella to produce the product for clinical trials.”
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