Arovella’s IND for ALA-101 accepted by the U.S. Food and Drug Administration
Highlights:
IND application accepted by the U.S. FDA for ALA-101
IND acceptance enables Arovella to progress the first-in-human clinical trial for ALA-101
The accepted IND provides the framework for all future CAR-iNKT cell programs under development, including ALA-105 and other solid tumour products
MELBOURNE, AUSTRALIA 29 January 2026: 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 the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for ALA-101 to commence first-in-human clinical trials.
The IND acceptance represents a key operational and regulatory milestone for Arovella, enabling the Company to commence first-in-human phase 1 clinical trials of ALA-101 in patients with CD19-positive nonHodgkin’s lymphoma (NHL) and leukaemia. Importantly, securing the IND 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.
The acceptance of the IND by the U.S. FDA provides regulatory validation of ALA-101’s preclinical package, manufacturing process, and overall clinical development plan, which is a major de-risking step for the Company. Importantly, Arovella anticipates that the successful ALA-101 IND application will provide a framework that can be leveraged in the development of pipeline products, including ALA-105 for the treatment of gastric cancer, and potentially for new technologies targeting neuroblastoma and hepatocellular carcinoma currently being negotiated for license from Baylor College of Medicine.
Dr Michael Baker, Managing Director and Chief Executive Officer of Arovella Therapeutics, said: “The team has done an amazing job capturing all of the experimental data and related technical information required for a successful IND submission. To have it accepted by the U.S. FDA demonstrates the capability of our team and the Company’s selected partners, including our manufacturer, Cell Therapies Pty Ltd. We have initiated the activities required for our Human Research Ethics Committee (HREC)submission and clinical trial site selection and activation. Now that the IND is accepted, we look forward to accelerating these activities and taking ALA-101 into the first-in-human phase 1 clinical trial. We are hopeful that ALA-101 will bring meaningful benefit to patients enrolled in the study who would otherwise have no remaining treatment options.”
ALA-101 is Arovella’s lead allogeneic cell therapy product derived from iNKT cells engineered to express a CD19-specific chimeric antigen receptor (CAR). The product offers several potential advantages over firstgeneration CAR-T approaches, including a scalable and cost-efficient manufacturing process that enables “off-the-shelf” dosing, helping to reduce the time to treatment and improve patient access.
The planned Phase 1 clinical study will assess the safety, tolerability, pharmacokinetics, and preliminary antitumour activity of ALA-101 in patients with relapsed/refractory CD19-positive NHL and leukaemias