Arovella Therapeutics Completes Process Development For ALA-101 Manufacturing

Arovella Therapeutics Ltd (ASX: ALA) has achieved a milestone by completing process development for large-scale Good Manufacturing Practice (GMP) manufacturing of its lead product, ALA-101.

ALA-101 holds promise as a next-generation treatment for CD19-positive blood cancers, including non-Hodgkin’s lymphomas and leukemias.

Watch: Arovella Therapeutics CEO Dr Michael Baker Outlines 2024 Clinical Milestones with JustStocks Video Following $12.5 Million Raise

Essential for regulatory approval

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.

Read: Arovella Therapeutics Secures $12.5 Million to Advance CAR-iNKT Cell Therapy for Cancer

Balanced product

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 that have been shown to be more cytotoxic than CD4+ cells.

The expectation is that a balanced product with a mix of these cell phenotypes may lead to superior efficacy.

“Incredibly exciting”

Arovella 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.

“This enables us to achieve our vision of taking allogeneic CAR-iNKT cells into clinical trials and, ultimately, commercial development.

“We look forward to continuing this momentum as we progress towards our phase 1 clinical trial for ALA101.”

 

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