Neuroblastoma represents 8 to 10% of all childhood cancers, is the second most common cancer in children and the most common cancer in children under one year of age.
In addition, 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of 50% over 5 years.
Each year, more than 500 HRNB patients are diagnosed in Europe and 300 in the US. The current standard of care includes multiple cycles of chemotherapy, surgery, radiotherapy, stem cell transplantation and anti-GD2 monoclonal antibody (mAb) treatment.
Hu14.18 is an anti GD2 humanised mAb. A recent phase 2 trial incorporating the treatment into induction therapy and within post-consolidation therapy, demonstrated outstanding patient outcomes with OS of 86.0% and EFS of 73.7%4.
Within the patient population, 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.
Under the terms of the licensing agreement, Renaissance Pharma has secured exclusive development, manufacturing and commercialisation rights to US, Canada, Europe, China, Japan and Turkey.
Renaissance will now pursue interaction with the FDA, EMA and other regulatory agencies internationally to configure the ‘optimal path’ for Hu14.18’s submission.
Lee Morley, executive chairman of Renaissance Pharma, said: “We couldn’t be more motivated by the prospect of bringing Hu14.18 to patients. The phase 2 data as published in the Journal of Oncology is breathtaking and I am certain that the neuroblastoma community will be as excited as we are when considering the potential significance of this breakthrough treatment.”
“Our responsibility is now to continue the journey that St. Jude so professionally began. Our intent is simple, to get Hu14.18 into the hands of treating physicians as swiftly as possible so the potential benefits Hu14.18 offers can be passed on to the patients that so desperately need them. This responsibility begins immediately.”
Simon Ball, CEO of Renaissance Pharma, added: “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.”
Sara Federico, pediatric oncologist at St. Jude Department of Oncology, also described the partnership as ‘exciting and deeply meaningful’ and believes Hu14.18 will now have the potential to positively impact patients with high-risk neuroblastoma around the world.