Renaissance Pharma has announced its first development programme focused on Hu14.18, a humanised anti-GD2 monoclonal antibody (mAb), licensed from St Jude Children’s Research Hospital for the treatment of newly diagnosed high-risk neuroblastoma.
Fifty percent of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over five years. The current standard of care includes multiple cycles of chemotherapy, surgery, radiotherapy, stem cell transplantation and anti-GD2 mAb treatment.
A novel Phase II trial incorporating Hu14.18 into induction therapy and additionally, within post-consolidation therapy, demonstrated outstanding patient outcomes with overall survival (OS) of 86.0% and three-year event-free (EFS) of 73.7%.
Within the patient population, where an antibody was used in all patients prior to consolidation and maintenance, 66.7% achieved a partial response or better after the first two chemo-immunotherapy induction cycles, and 96.8% achieved a partial response or better at the end of induction.
Renaissance will now pursue interaction with the FDA, EMA and other regulatory agencies internationally to configure the optimal path for Hu14.18’s submission.
Simon Ball, CEO of Renaissance Pharma, said: “It is rare to have the opportunity to make such a significant improvement in a treatment paradigm; with Hu14.18, we have just that opportunity. Renaissance Pharma now has its full attention on bringing this humanised antibody to market as expeditiously as possible. The collaboration with St Jude marks the intention of Renaissance and we must now play our part in making the product available.”