Arovella Therapeutics (ASX: ALA), a pioneering force in the biotech sector, has fortified its financial position with a $20 million capital raise to drive the development of its CAR-iNKT cell therapy platform. This milestone marks a significant step forward for the Melbourne-based company as it readies its lead product, ALA-101, for first-in-human Phase 1 clinical trials targeting CD19-positive blood cancers.
Strategic Backing Signals Confidence
Announced on 10 January 2025, the placement priced shares at $0.17, a modest 2.9% discount to Arovella’s last traded price of $0.175. A single cornerstone investor contributed $15 million, underscoring strong faith in the company’s differentiated technology. Contributions also came from institutional players like Pengana Capital Group and other sophisticated investors. Post-raise, Arovella’s cash balance will exceed $30 million, providing ample runway to fund key clinical milestones.
Dr Thomas Duthy
Chairman Dr Thomas Duthy lauded the support, describing the raise as a "pivotal moment" for the company. "This capital equips us to execute our plans, particularly advancing ALA-101 through Phase 1 trials and progressing our pipeline of solid tumour programs," he said.
CAR-iNKT: A Next-Generation Oncology Solution
At the core of Arovella’s innovation is its CAR-iNKT platform, a groundbreaking approach that combines chimeric antigen receptor (CAR) technology with invariant natural killer T (iNKT) cells. Unlike conventional CAR-T therapies, Arovella’s allogeneic CAR-iNKT cells are "off-the-shelf," enabling quicker and more accessible treatments without the need for patient-specific engineering.
ALA-101, the lead candidate, targets CD19—a protein expressed on many blood cancers, including non-Hodgkin’s lymphoma and leukemia. The therapy’s dual targeting capability enhances its potential to attack tumours while mitigating relapse risks.
Path to Clinical Trials
The funds will enable Arovella to achieve several key milestones in 2025, including:
- Filing an Investigational New Drug (IND) application with the US FDA in Q1.
- Commencing a Phase 1 trial for ALA-101 in mid-2025.
- Securing initial clinical data on ALA-101’s safety, tolerability, and preliminary efficacy.
- Advancing proof-of-concept studies for CLDN18.2-targeted iNKT therapies in gastric and pancreatic cancers.
Preparation for trials is already well underway. The company has assembled a world-class Clinical Advisory Board, including luminaries like Dr Sattva Neelapu of MD Anderson Cancer Center, who was pivotal in the development of Yescarta®, a leading CAR-T therapy.
Expanding into Solid Tumours
Beyond blood cancers, Arovella is venturing into the solid tumour landscape with its Claudin 18.2-targeting programs. This protein is highly expressed in gastric, pancreatic, and other solid tumours. The company is leveraging its recently licensed IL-12-TM technology to enhance CAR-iNKT activity, a critical step in addressing the challenges of treating solid tumours.
The manufacturing capabilities developed for ALA-101 offer scalability, enabling the seamless integration of new CAR constructs for future products. As solid tumours account for 90% of cancer diagnoses, these programs could open vast new markets.
Positive Momentum
At the recent AGM, CEO Dr Michael Baker highlighted the transformative progress made in FY2024, from GMP manufacturing of ALA-101’s lentivirus to regulatory advancements. "We are at a juncture where our innovations can truly impact patients’ lives. This capital raise validates the strength of our platform and our ability to execute," Baker stated.
The Road Ahead
Arovella’s strategic focus on CAR-iNKT therapies places it at the forefront of next-generation oncology solutions. With robust financial backing, a strong leadership team, and a rapidly advancing pipeline, the company is well-positioned to deliver breakthroughs in cancer treatment.
The market will keenly watch the progress of ALA-101 and the evolution of its solid tumour programs, as Arovella strives to redefine the paradigm of cancer care.
