With a mission of “Bolstering human immunity by utilizing empowered antibody therapies”, the SparX Group announced that the FDA has approved their IND application for its organically developed anti-claudin18.2 antibody, SPX-101. 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.
Dr. Gui-Dong Zhu, the President, CEO and founder of the company stated, “This is a significant milestone for SparX. The FDAs approval validates the effectiveness of SparX’s SAILINGTM antibody discovery platform. This platform is composed of seven proprietary modules, encompassing the entire process for antibody-based drug discovery and production. Few start-up biotech companies are able to identify unique targets, discover and optimize antibody therapeutics, and produce the drug substance and prepare the IND submission package all in-house. It is gratifying that the FDA approval of our IND has substantiated SparX’s capabilities to do so.””Claudin18.2 is a highly specific tumor antigen, but optimizing therapeutic targeting could still benefit from a more sophisticated molecular design and selection algorithms in order to maximize the therapeutic window. We are aware of the fierce competition in the field, but we believe SPX-101 is a uniquely designed and carefully selected compound that has the potential to be a best-in-class molecule coupled with task specific formulation. Our sophisticated basket trial design, along with a first-in-class companion diagnostic, will help us to stand out during the development stage,” said Dr. Zhu.
