First-in-human trial
Highlights:
On top of US FDA IND acceptance and TGA acknowledgement, Arovella now has ethics approval for it’s first-in-human clinical trial of ALA-101
ALA-101 is Arovella’s lead allogeneic CAR-iNKT cell therapy for patients with blood cancer
The Alfred in Melbourne is lead clinical site, with Dr Salvatore “Sam” Fiorenza Lead Investigator
Site initiation activities have commenced with first patient dosing expected in September, after each site’s Research Governance Office (RGO) approval
“First-in-human cannot happen fast enough for me because there is a long list of patients with nowhere else to go.” David Williams, Chairman
Arovella Therapeutics Ltd (ASX: ALA), is a clinical-stage biotechnology company focused on developing its “off-the-shelf” invariant Natural Killer T (iNKT) cell therapy platform, has received ethics approval to commence its phase 1 first-in-human clinical trial of ALA-101, it’s lead allogeneic CD19-directed CAR-iNKT cell therapy for patients with relapsed or refractory lymphomas and leukemias.
The phase 1 trial, is an open label, first-in-human dose-escalation and expansion/backfill study designed to evaluate the safety, tolerability and preliminary anti-tumour activity of ALA-101 in patients with certain blood cancers.
The Alfred in Melbourne is the lead clinical site, with experienced CAR-T cell therapy clinician Dr Salvatore “Sam” Fiorenza Lead Investigator. The trial will involve up to seven clinical sites across Australia and New Zealand, with broader site activation activities also underway at Epworth Healthcare, St Vincents Sydney, The Mater Brisbane and Royal Adelaide Hospital.
Ethics approval has been obtained from The Alfred and Bellberry Human Research Ethics Committees, providing central ethics support for participating study sites. The approval follows Arovella’s U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application clearance, and Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) acknowledgement. Completing the key regulatory and ethics approvals required to initiate the study.
Arovella remains on track to commence first patient dosing in Q3 CY2026.
The Lead Investigator, Dr Sam Fiorenza commented, “There is a substantial unmet need for patients with relapsed or refractory haematological cancers, particularly for patients who have exhausted existing treatment options. As clinician researchers, finding novel therapies that will result in better outcomes for our patients is the hope, and we are pleased to be part of the evaluation of this new approach.”
Acting Chief Executive Officer, Dr Nicole van der Weerden, said: “First-in-human is an important step in our transition to a clinical-stage company and is the culmination of the disciplined approach we have taken in regulatory, manufacturing and clinical readiness. We are preparing to complete site initiation and first patient dosing. This milestone means we can evaluate the potential of our allogeneic CAR-iNKT platform for patients with significant unmet medical need and generate clinical data important for patients, clinicians and shareholders. I anticipate exciting and important data to come from this trial”
View lead investigator Dr Sam Fiorenza and Chairman David Williams on Sky Business below: