Arovella files IND with the U.S. FDA for ALA-101 phase 1 clinical trial
MELBOURNE, AUSTRALIA 30 December 2025: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, is pleased to announce that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead cell therapy candidate, ALA-101, an allogeneic CAR-iNKT cell therapy targeting CD19-positive non-Hodgkin’s lymphoma (NHL) and leukaemias.
The IND submission represents a major operational and regulatory milestone for Arovella, enabling the Company to progress ALA-101 towards its first-in-human Phase 1 clinical trial, pending FDA clearance. FDA review of the IND application typically occurs within 30 days. The Company will update the market following notification from the Agency.
ALA-101 is Arovella’s lead allogeneic cell therapy product derived from iNKT cells engineered to express a CD19-specific chimeric antigen receptor (CAR). An off-the-shelf product offers several potential advantages over first-generation CAR-T approaches, including, a manufacturing process that is scalable and cost-efficient and enables “off-the-shelf” dosing to reduce the time to treatment for patients and improved access.
The planned Phase 1 clinical study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of ALA-101 in patients with relapsed/refractory CD19-positive NHL and leukaemias. Obtaining an active IND is a critical step for Arovella as it enables the company to conduct its Phase 1 trial in Australia via the Clinical Trial Notification (CTN) scheme rather than the lengthier Clinical Trial Application (CTA) pathway. It also enables Arovella to open clinical trial sites in the U.S.
Dr Michael Baker, Chief Executive Officer and Managing Director of Arovella Therapeutics, said:
“Filing the IND for ALA-101 is an excellent milestone for Arovella, and we look forward to receiving the feedback from the FDA. It reflects the strength of our scientific and manufacturing foundations and marks the Company’s transition toward becoming a clinical-stage biotechnology company.”