Highlights

  • A second clinical batch of ALA-101 has been manufactured and released for patient use.
  • Supply is sufficient to complete dose escalation and begin dose expansion.
  • First patient dosing is expected in late October 2026.
  • A third batch is expected before year-end.

Arovella Therapeutics Limited (ASX:ALA) announced on 7 October 2026 that a second clinical batch of its ALA-101 cell therapy has been manufactured and released for immediate patient use. ALA-101 is being studied in a Phase 1 trial in blood cancers.

Second Batch and Supply Position

The second batch provides enough product to complete dose escalation and begin dose expansion in the trial. A third batch is expected before the end of the year and is anticipated to supply the material needed to complete the Phase 1 study.

Chairman David Williams said the company is ready to go and will soon have enough product on hand to dose all 46 patients.

Phase 1 Trial Progress

The Phase 1 trial will involve 46 patients across five hospital sites, with first patient dosing expected in late October 2026.

Epworth Hospital in Melbourne has been activated, while St Vincent's Hospital in Sydney and the Mater Hospital in Brisbane are expected to be activated soon. Acting CEO Dr Nicole van der Weerden described treating the first patient as a defining milestone for the company.

About ALA-101

ALA-101 consists of CAR19-iNKT cells derived from healthy donors and targets the CD19 antigen found on certain cancer cells.

Because it uses donor cells, the therapy can be manufactured in advance and stored. Arovella says this off-the-shelf model addresses Manufacturing bottlenecks associated with conventional CAR-T therapies.

Key Takeaways

  • Arovella has released a second clinical batch of ALA-101.
  • Supply now covers completion of dose escalation and the start of dose expansion.
  • First patient dosing is expected in late October 2026.
  • A third batch due before year-end is expected to support completion of the 46-patient trial.