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- Arovella Therapeutics (ASX:ALA) inks a global and exclusive license agreement with Sparx Group to develop a world-first iNKT cell therapy to target a protein called CLDN18.2
- Sparx has a phase one ready antibody, SPX-101, which targets CLDN18.2
- Arovella will use SPX-101 to generate a CAR to be incorporated into its iNKT cell platform to treat gastric cancers, gastroesophageal junction cancers, and pancreatic cancers
- The novel antibody sequence presents a new market for creating direct cancer-killing ability in drugs, compared to regular antibodies alone
- AVA shares last traded at 7.8 cents
Arovella Therapeutics (ASX:ALA) has inked a global and exclusive license agreement with Sparx Group to develop a world-first iNKT cell therapy targeting a protein called CLDN18.2.
Sparx has a phase one ready antibody, SPX-101, which targets CLDN18.2. This antibody has shown promise in preclinical studies and has received investigational new drug (IND) status from the US Food and Drug Administration.
Arovella is planning to use the SPX-101 sequence to generate a chimeric antigen receptor (CAR) that will be incorporated into its iNKT cell platform to treat gastric cancers (GC), gastroesophageal junction cancers (GEJC) and pancreatic cancer (PC) with a novel monoclonal antibody (mAb) sequence.
The drug is known to have a direct cancer-killing ability compared to regular antibodies like SPX-101 alone, and AVA has completed all preclinical proof-of-concept, safety and specificity studies and toxicology studies required to begin a phase one trial.
“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,” AVA CEO and Managing Director Dr Michael Baker said.
“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.”
Several products are currently under clinical development for these cancers, the most advanced is zolbetuximab. Zolbetuximab has been awarded priority review for treating GC and GEJC by the FDA, highlighting the high unmet need for patients with these diseases.
The FDA’s decision to approve zolbetuximab is expected in January 2024, and Astellas has forecast peak annual sales of US$0.6-1.3 billion for zolbetuximab.
Despite Arovella’s CLDN18.2-iNKT program being preclinical, and yet to demonstrate efficacy, these forecasts support the potential market for an FDA-approved therapeutic targeting CLDN18.2.
ALA shares last traded at 7.8 cents.
