Arovella completes manufacturing scale-up
Highlights:
Critical process finalised for GMP manufacturing of ALA-101, demonstrating a high yield of
CAR19-positive iNKT cells with very high purityProcess suitable for large-scale and late-phase clinical development
Process maintains highly cytotoxic iNKT cell phenotype
Progressing to engineering and GMP batches to produce material for phase 1 clinical trials
Arovella’s proprietary manufacturing process suitable for all of Arovella’s current and future iNKT cell programs
MELBOURNE, AUSTRALIA 5 June 2024: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, is pleased to announce that it has achieved a significant milestone by completing process development for its patent protected manufacturing process required for large-scale Good Manufacturing Practice (GMP) manufacturing of its lead product, ALA-101.
The modular, semi-automated process, developed at Cell Therapies Pty Ltd, is suitable for large-scale manufacturing and produces a high yield of Chimeric Antigen Receptor (CAR)-positive iNKT cells with very high purity. A well-controlled and reproducible GMP manufacturing process is essential for regulatory approval for first-in-human clinical trials. Arovella can now proceed with engineering and GMP batches to produce material for phase 1 clinical trials. The manufacturing process uses well-known automated cell therapy equipment, significantly reducing technology transfer risks to new jurisdictions.
The final product characteristics are consistent with the expectations of global regulators such as the US FDA for product quality and safety. The process maintains the beneficial highly cytotoxic CD4-negative population of iNKT cells, as described in Arovella’s licensed patents, that have been shown to be more cytotoxic than CD4+ cells in a recent presentation at the American Association for Cancer Research (AACR) Annual Meeting. The expectation is that a balanced product with a mix of these cell phenotypes may lead to superior efficacy.
Achievement of this milestone will facilitate Arovella’s pipeline expansion for its CAR-iNKT cell platform. The manufacturing process can be applied to all of Arovella’s future CAR-iNKT cell products, significantly reducing the time required to proceed from proof-of-concept data to clinical manufacture for programs with new CARs. Different CARs that recognise different tumour types can be added to iNKT cells through the use of new lentiviral vectors that will be manufactured to GMP standards (for example, Claudin 18.2-targeting CAR-iNKT cells).
Managing Director, Dr Michael Baker, commented, “Process development for our CAR-iNKT manufacturing process has been a primary focus for Arovella over the past year, and it is incredibly exciting to have completed this step. For all cell therapy products, the manufacturing process defines your product. We have been diligent to ensure that our proprietary manufacturing process is robust and delivers high-yield, high-purity products. This enables us to achieve our vision of taking allogeneic CAR-iNKT cells into clinical trials and, ultimately, commercial development. I am proud of the team for achieving this milestone and thankful to Cell Therapies Pty Ltd for their partnership and the experience they have contributed.
We look forward to continuing this momentum as we progress towards our phase 1 clinical trial for ALA-101.”