Arovella Therapeutics (ASX:ALA) has signed a global, exclusive license agreement with Sparx Group for the use of a novel monoclonal antibody (mAb) sequence targeting Claudin 18.2 (CLDN18.2) in cell therapies.
The mAb, known as SPX-101, has completed all preclinical proof-of-concept, safety and specificity studies and toxicology studies required to commence a Phase 1 trial to treat gastric cancers.
Arovella said it would use the SPX-101 sequence to generate a chimeric antigen receptor (CAR) that will be incorporated into its iNKT cell platform to target gastric cancer (GC), gastroesophageal junction cancer (GEJC), pancreatic cancer (PC), and other solid tumours.
CLDN18.2-iNKT cells with direct cancer-killing ability are expected to provide superior cancer killing properties relative to an antibody alone. CLDN18.2 is a validated target, demonstrated by the fact that there are several products currently in clinical development. The most advanced of these is zolbetuximab, which was acquired by Astellas Pharma after compelling phase 2 data during its takeover of Ganymed Pharmaceuticals in 2016 for €422 million up-front and the potential for €860 million in milestones.
Arovella CEO and managing director, Dr Michael Baker, said, “We are very excited to have licensed the CLDN18.2 mAb sequence for use in cell therapy. Sparx has completed excellent work demonstrating the superior activity of its CLDN18.2 mAb, and also its robust safety and specificity. CLDN18.2 is an exciting target, generating a lot of interest globally. Arovella will be the only company in the world developing a CAR-iNKT cell therapy targeting CLDN18.2. The natural benefits that iNKT cells may bring to solid tumours, combined with the CLDN18.2 CAR, is a compelling concept for cancer patients.”
Sparx Therapeutics CEO and managing director, Gui-Dong Zhu, added, “Our partnership with Arovella represents a transformative phase in advancing mAb-based therapies. Arovella’s cutting-edge CAR-iNKT platform, encapsulating advanced techniques for in vitro expansion and post-infusion persistence of iNKT cells, underscores their leadership in this domain. We profoundly acknowledge CLDN 18.2-iNKT cell therapy as a groundbreaking paradigm in oncological therapeutics.”
