Clinical manufacturing batch released, first site activated
Highlights:
ALA-101 is Arovella's "off-the-shelf" cell therapy for blood cancers
First clinical batch of ALA-101 has been successfully manufactured and now released for dosing in first-in-human study
First clinical trial site activated at The Alfred in Melbourne
Patient screening and enrolment can start, with first patient dosing expected later this month
Into the clinic
Arovella Therapeutics Ltd (ASX: ALA) is pleased to advise that it has manufactured and released the first clinical batch of ALA-101 and activated The Alfred as the first clinical trial site for its human phase 1 study.
Site activation at The Alfred follows completion of ethics and governance approvals and site initiation. With a site open and product in hand, Arovella expects to dose its first patient this month.
Oils ain’t oils
ALA-101 is a donor-derived cell therapy made in batches from healthy donor cells rather than each patient’s own cells. This has the potential to be delivered to the patient faster and manufactured at a lower cost than conventional therapies derived from a patient’s own blood. This is a key differentiator for Arovella, for patient health, and for speed of treatment.
Successful clinical manufacturing is a critical step toward demonstrating the key advantages of Arovella’s platform of off-the-shelf availability, rapid access to treatment, and the potential to overcome many of the manufacturing and cost limitations associated with using a patient’s own cells. The manufacturing process utilised for ALA-101 is expected to be broadly applicable across other products developed using Arovella's platform.
Arovella Acting CEO, Dr Nicole van der Weerden, said, "Releasing our first clinical batch is a significant achievement and key milestone. Manufacturing our product to clinical standard, meeting FDA requirements and having it ready for patients is a game changer and demonstrates that our platform works in practice. With our lead site now activated and product available, our focus turns to screening and enrolling the first patient." A video of Dr van der Weerden discussing this announcement can be viewed below or here.
Arovella Chairman, Mr David Williams, added, "Activating our first site and releasing our first clinical batch are very important and move us out of the lab and into patients. However, the most important thing is to be able to manufacture cells in bulk without relying on the patient’s cells. Arovella’s off-the-shelf product shall be cheaper, faster and available when patients need it." A short video of Mr Williams discussing this announcement can be viewed below or here.
The Company will update the market as further sites are activated when it doses the first patient.