Arovella Therapeutics Ltd (ASX:ALA) has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its lead cell therapy candidate, ALA-101.
ALA-101 is an allogeneic CAR-iNKT cell therapy designed to target CD19-positive non-Hodgkin’s lymphoma (NHL) and leukaemias. The filing is a key regulatory step toward starting a first-in-human Phase 1 clinical trial, subject to FDA clearance.
The FDA’s review of IND submissions typically occurs within 30 days, with Arovella indicating it will update the market once it receives a decision from the agency.
ALA-101 is an “off-the-shelf” product derived from invariant Natural Killer T (iNKT) cells engineered to express a CD19-specific chimeric antigen receptor (CAR). An allogeneic approach has the potential to support scalable manufacturing and faster dosing compared with first-generation autologous CAR-T therapies, reducing time to treatment and improving patient access.
The planned Phase 1 study is intended to assess safety and tolerability, as well as pharmacokinetics and preliminary anti-tumour activity, in patients with relapsed or refractory CD19-positive NHL and leukaemias.
Arovella said an active IND is also significant from an execution standpoint, as it would enable the trial to proceed in Australia under the Clinical Trial Notification (CTN) scheme rather than the Clinical Trial Application (CTA) pathway, and would support the opening of clinical trial sites in the US.