Biotech company Arovella Therapeutics (ASX: ALA), focused on developing its invariant Natural Killer T (iNKT) cell therapy platform for cancer treatment, has achieved a major milestone. It has completed process development for its patent-protected manufacturing process required for large-scale Good Manufacturing Practice (GMP) manufacturing of its lead product, ALA-101.

ALA-101 is an “off-the-shelf” CAR-iNKT cell therapy that targets CD19+ B cell lymphomas and leukaemias. The new process, created with Cell Therapies, is partly automated and ensures a high number of high-quality CAR (chimeric antigen receptor)-positive iNKT cells, which are necessary for treating cancer. 

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.”

Arovella is a biotechnology company focused on developing its iNKT cell therapy platform from Imperial College London to treat blood cancers and solid tumours. Arovella’s lead product is ALA-101, which produces a CAR that targets and kills CD19, an antigen found on the surface of numerous cancer types. 

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 manufacturing batches to produce material for phase 1 clinical trials. The process uses well-known automated cell therapy equipment, significantly reducing technology transfer risks to new jurisdictions. 

Baker added, “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 ALA101.”

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. In a presentation at the American Association for Cancer Research (AACR) Annual Meeting, these cells were shown to be more cytotoxic, i.e. damaging to cells, than CD4+ cells, i.e. white blood helper cells. 

The expectation is that a balanced product with a mix of these cell phenotypes may lead to superior efficacy. By achieving this milestone, Arovella will be able to expand its pipeline for the 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. 

Going forward, the iNKT cells would be able to include different CARs that recognise different tumour types by using new lentiviral vectors that will be manufactured to GMP standards. In doing so, it will further advance cancer treatment solutions.