Biotech company Arovella Therapeutics Ltd (ASX:ALA), which specialises in invariant Natural Killer T (iNKT) cell therapy, has hit a milestone in the process development for its lead product, ALA-101.
The company has finalised the critical process for Good Manufacturing Practice (GMP) manufacturing of ALA-101, which demonstrates a high yield of Chimeric Antigen Receptor (CAR) 19-positive iNKT cells with exceptional purity.
Large-scale manufacturing
Arovella’s proprietary manufacturing process represents a leap forward in the development of iNKT cell therapy.
The modular, semi-automated process, developed at Cell Therapies Pty Ltd, is suitable for large-scale manufacturing and late-phase clinical development.
This process is crucial for regulatory approval for first-in-human clinical trials, allowing Arovella to progress to engineering and GMP batches to produce material for phase 1 clinical trials.
The manufacturing process uses well-known automated cell therapy equipment, reducing technology transfer risks significantly.
Final product characteristics align with the expectations of global regulators, such as the US Food and Drug Administration (FDA), for product quality and safety.
Notably, the process maintains the highly cytotoxic CD4-negative population of iNKT cells, as outlined in Arovella's licensed patents.
Greater cytotoxicity and efficacy
These CD4-negative cells have shown greater cytotoxicity compared to CD4-positive cells, potentially leading to superior efficacy.
This achievement is expected to facilitate the expansion of Arovella’s pipeline for its CAR-iNKT cell platform.
The manufacturing process is applicable to all of Arovella's future CAR-iNKT cell products, significantly reducing the time from proof-of-concept data to clinical manufacture for new CAR programs.
Different CARs that target various tumour types can be incorporated into iNKT cells using new lentiviral vectors manufactured to GMP standards, such as Claudin 18.2-targeting CAR-iNKT cells.
Managing director Dr Michael Baker said: “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.
High-yield, high-purity product
“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.”