Arovella Therapeutics Ltd has successfully secured $20 million through a share placement to fund the completion of a Phase 1 clinical trial for its lead product, ALA-101, aimed at treating CD19-positive blood cancers. The funding will also support the expansion of the company’s solid tumor programs and strengthen its iNKT cell therapy pipeline.
Advancing ALA-101 Clinical Trials
The funding positions Arovella to achieve significant milestones, including gaining Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA), commencing clinical trials, and securing proof-of-concept data for solid tumor treatments. Arovella had a strong cash position of $11.8 million as of December 31, 2024, bringing the pro-forma cash balance to $30.6 million post-placement.
Clinical Advisory Board and Strategic Roadmap
During the second quarter of FY25, Arovella established a Clinical Advisory Board (CAB) to optimize its trial design ahead of an IND application with the FDA. The board includes Dr. Salvatore Fiorenza, Professor Sattva Neelapu, and Dr. Debora Barton, providing expert clinical insight and strategic advice focusing on CD19-positive hematological malignancies.
In the remainder of FY2025, Arovella aims to complete clinical batch manufacturing of ALA-101 and secure IND approval, paving the way for patient dosing and initial clinical data generation. The company also anticipates delivering proof-of-concept data for its solid tumor programs, expanding its iNKT platform.
Additional Funding and Research Support
Arovella received A$3.3 million as part of its financial year 2024 Research and Development (R&D) Tax Incentive refund. During the quarter, Arovella also secured funding through the G-Rex® Grant Program, a US$20 million initiative backed by ScaleReady, Wilson Wolf, Bio-Techne®, and CellReady™. Arovella has been awarded up to US$150,000 in equipment, consumables, and consultation over 18 months to refine its clinical manufacturing process using G-Rex® closed-system bioreactors.
