Arovella Therapeutics achieves significant milestone in process development

Arovella Therapeutics Ltd (ASX: $ALA) has completed the process development for its patent protected manufacturing process required for large-scale Good Manufacturing Practice (GMP) manufacturing of its lead product, ALA-101. The achievement marks a critical step for the company in advancing its invariant Natural Killer T (iNKT) cell therapy platform.

Executive commentary on achieving the milestone

Dr Michael Baker, Managing Director, expressed, '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.'

Summary of Arovella Therapeutics' achievement and outlook

Arovella Therapeutics Ltd (ASX: $ALA) has successfully finalized the critical process for GMP manufacturing of ALA-101, a significant achievement that paves the way for large-scale and late-phase clinical development. The completion of the modular, semi-automated process, with a high yield of CAR19-positive iNKT cells and very high purity, demonstrates the company's commitment to advancing its iNKT cell therapy platform. The achievement not only enables the production of material for phase 1 clinical trials but also positions Arovella for pipeline expansion and future CAR-iNKT cell programs. With the proprietary manufacturing process suitable for all current and future iNKT cell programs, Arovella is poised to reduce the time required to proceed from proof-of-concept data to clinical manufacture for programs with new CARs. Driven by the vision of taking allogeneic CAR-iNKT cells into clinical trials and commercial development, Arovella looks ahead to the next phase of its journey with optimism and determination.