SparX announced that the FDA has approved their IND application for its organically developed anti-claudin18.2 antibody, SPX-101. The first patient is set to receive their initial dose in March of 2022. SPX-101 is a highly selective anti-claudin18.2 monoclonal antibody.

The antibody was discovered, then biologically and biophysically improved, using a customized optimization funnel, taking advantage of the acidity in the tumor microenvironment and Fc-mediated immune effects. SparX Group has built a well-equipped pilot plant at its Mount Prospect, IL location. This facility encompasses process development through cGMP production, including QC laboratories, supplying the deliverables required for IND filing and early-stage clinical development.

By the end of 2022, the company's Yangzhou facility will launch and be able to supply material needs for later stages of development, and ultimately commercial production.