Highlights:
Arovella achieves major milestone with first patient dosed in its phase 1 clinical trial of ALA-101, Arovella's "off-the-shelf" cell therapy for blood cancers
Trial will evaluate the safety, tolerability, pharmacology and preliminary efficacy of ALA-101 in patients with certain blood cancers
Arovella Therapeutics Ltd (ASX: ALA) is pleased to announce the achievement of a major milestone with the dosing of the first patient in its first-in-human phase 1 clinical trial. The SAPPHIRE study (ALA-101-001; NCT07518329) is an open-label, multi-centre, dose-escalation and expansion trial evaluating ALA-101, Arovella's allogeneic off-the-shelf CD19 CAR-iNKT cell therapy, in patients with relapsed or refractory CD19-positive non-Hodgkin lymphoma and leukaemia.
The patient received ALA-101 following standard lymphodepleting chemotherapy at The Alfred under the supervision of Dr Salvatore (Sam) Fiorenza.
Lead Investigator, Dr Sam Fiorenza, commented, "Dosing the first patient with ALA-101 is a key milestone in the development of a new class of cell therapies for patients with relapsed or refractory B cell malignancies. Despite advances in treatment, many patients either relapse following standard therapies or are unable to access currently available autologous CAR-T therapies. We look forward to evaluating the safety and potential clinical activity of ALA-101 and contributing to the advancement of this novel allogeneic CAR-iNKT cell approach."
Dr Nicole van der Weerden, Acting Chief Executive Officer of Arovella, commented, "Dosing the first patient is a milestone and the culmination of several years of focused scientific, manufacturing, regulatory and clinical development. It is immensely satisfying to see the work of our team and collaborators translate into the delivery of our novel cell therapy to a patient for the first time. ALA-101 has been designed to overcome key limitations of conventional CAR-T therapies by using healthy donor-derived iNKT cells that can be manufactured in advance and supplied when needed. This trial will provide important insights into the safety, expansion, persistence and B cell-depleting activity of ALA-101 and support the development of Arovella's broader CAR-iNKT platform across blood cancers, solid tumours and autoimmune diseases. We are deeply grateful to the patient, the clinical team and everyone who has contributed to reaching this milestone."
David Williams, Chairman, said “Our killer T cell technology licenced from Imperial College London is a game changer. Our treatment is manufactured and sitting on a shelf ready for use, derived from healthy donors. The current treatment requires a patient’s own cells, a process that is costly and time-consuming.”