Global pharmaceutical giant Roche's recent acquisition of Poseida Therapeutics for US$1.5 billion underscores the significant potential and growing interest in cell therapy for cancer treatment. This move highlights the value of companies developing innovative approaches, particularly in the realm of allogeneic or "off-the-shelf" cell therapies. Arovella Therapeutics (ASX:ALA), an Australian biotech company, is also making strides in this space, with plans to initiate Phase 1 clinical trials in 2025.
Strategic Acquisition Before Phase 1 Data
Roche's acquisition of Poseida, which includes US$1 billion upfront and US$500 million in milestone payments, is notable because it occurred before the release of Poseida's Phase 1 trial results. This indicates a strong belief in Poseida's technology and its potential to revolutionize cancer treatment. Poseida and Arovella share key similarities, both focusing on blood cancers and developing allogeneic cell therapies. Poseida utilizes CAR-T technology, while Arovella is developing an invariant Natural Killer T (iNKT) cell therapy platform.
Arovella's iNKT Cell Therapy Platform
Arovella Therapeutics is advancing its ALA-101 iNKT cell therapy platform, targeting blood cancers that express the CD19 antigen. The company anticipates completing its Investigational New Drug (IND) submission with the FDA in Q1 2025 and commencing Phase 1 trials in the first half of the year. ALA is also developing ALA-105 (CLDN18.2), another iNKT cell therapy targeting solid tumors such as pancreatic, gastric, and lung cancers. Preclinical studies have demonstrated the ability of ALA's solid tumor therapy to kill cancer cells in in vivo models.
Promising Preclinical Data
Early data from Arovella's preclinical studies in mice have shown promising results, with its cell therapy demonstrating rapid cancer elimination compared to existing therapies. Notably, the studies also observed spontaneous secondary remission, where cancer cells reappeared but were subsequently destroyed. This suggests that ALA's therapy may provide long-term protection against cancer recurrence.
Clinical Advisory Board Expertise
Arovella has assembled a strong clinical advisory board, including Professor Sattva Neelapu, a key figure in the development and FDA approval of Kite Pharma's Yescarta, a CAR-T therapy for large B-cell lymphoma. Professor Neelapu's expertise will be invaluable as Arovella navigates the regulatory landscape and advances its clinical research program. Yescarta generated US$1.5 billion in sales for Gilead Life Sciences in 2023, highlighting the commercial potential of successful cell therapies.
The Growing Cancer Therapeutics Market
The cancer therapeutics market is currently valued at approximately US$200 billion and is expected to grow rapidly. With patents for blockbuster drugs like Merck's Keytruda set to expire, there is increasing pressure to develop new and effective cancer therapies. Cell therapies, with their potential to precisely target and kill cancer cells while minimizing damage to healthy tissues, are at the forefront of this innovation.
Next Steps for Arovella
Arovella's key milestones in the near future include completing process development and scale-up, progressing to engineering and GMP batches to produce material for clinical trials, submitting the IND application to the FDA (expected in Q1 2025), announcing the clinical trial plan, securing ethics approval, and commencing the Phase 1 clinical trial with the first patient dosed.
