Arovella Therapeutics (ASX:ALA) has taken a key step toward the clinical development of its lead cell therapy candidate, ALA-101, appointing SAPRO as contract research organisation (CRO) for its first-in-human Phase 1 trial.
The company confirmed it has initiated start-up activities following positive feedback from the US Food and Drug Administration during a recent Type D meeting, with patient dosing expected to commence in early 2026.
“After positive feedback from FDA during our recent Type D meeting, we are excited to initiate start-up activities for the phase 1 clinical trial and are delighted to have found an excellent partner in SAPRO,” said Michael Baker, Chief Executive Officer and Managing Director of Arovella. “The data we obtain from this first-in-human trial informs not only the development of ALA-101, but also directly translates to Arovella’s solid tumour programs.”
The open-label, dose escalation and expansion study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of a single dose of ALA-101 in patients with CD19-positive non-Hodgkin’s lymphoma and leukaemia.
A Bayesian design will support efficient dose escalation to identify a safe and effective dose for expansion. Clinical sites are expected to be located across Australia and New Zealand. The commencement of the trial remains subject to ethics and institutional approvals.
“We’re thrilled to be chosen by Arovella as their Trial Pathway Partner and CRO on the ALA-101 clinical program, a truly innovative cell therapy targeting CD19-positive malignancies,” said Kim Steel, Managing Director of SAPRO. “The ALA-101 study represents a major step forward in Australian-led immunotherapy development across the globe."
ALA-101 is an off-the-shelf iNKT cell therapy engineered with a chimeric antigen receptor (CAR) that targets CD19, an antigen found on the surface of numerous cancer types. The platform combines CAR technology with the natural tumour-targeting capabilities of invariant Natural Killer T (iNKT) cells, offering a potentially powerful new treatment approach for blood cancers and, ultimately, solid tumours.