Arovella Therapeutics (ASX:ALA) has secured acceptance from the U.S. Food and Drug Administration for its investigational new drug application for ALA-101.
The decision clears the way for the Melbourne-based biotechnology company to begin first-in-human clinical trials of its lead cell therapy program, marking a major regulatory and operational milestone.
ALA-101 is designed to treat patients with CD19-positive non-Hodgkin’s lymphoma and leukaemia, populations that often face limited treatment options once standard therapies fail. With the FDA’s acceptance of the IND, Arovella can now initiate a Phase 1 clinical trial to evaluate the therapy’s safety, tolerability, pharmacokinetics, and early signs of anti-tumour activity.
The approval also enables the company to run its Australian trial under the more streamlined Clinical Trial Notification scheme and to open clinical trial sites in the United States, accelerating global development timelines.
Beyond enabling the first clinical study of ALA-101, the IND acceptance provides regulatory validation of Arovella’s underlying science, manufacturing processes, and development strategy. Importantly, the IND establishes a framework that can be reused across the company’s broader pipeline of invariant natural killer T (iNKT) cell therapies, including ALA-105 for gastric cancer and potential future programs targeting neuroblastoma and hepatocellular carcinoma. This platform-level endorsement represents a significant de-risking step as Arovella expands into both blood cancers and solid tumours.
ALA-101 differs from earlier CAR-T therapies by using allogeneic iNKT cells, allowing the treatment to be manufactured at scale and stored for off-the-shelf use. This approach has the potential to reduce costs, shorten the time to treatment, and improve patient access.