Renaissance Pharma launched and announced the signing of an exclusive license agreement with St. Jude Children’s Research Hospital for Hu14.18, a humanized antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.
Neuroblastoma represents 8-10% of all childhood cancers1, is the second most common cancer in children and is the most common cancer in children under one year of age2. 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over 5 years3. 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 humanized mAb. A novel Phase II trial incorporating Hu14.18 into induction therapy and additionally, within post-consolidation therapy, demonstrated outstanding patient outcomes with OS of 86.0% and EFS of 73.7%4. Within the patient population, where 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. Data from the successful Phase II study was published in the Journal of Clinical Oncology in December 2021 and will soon reach maturity in regard to its 5-year OS readouts5.
Renaissance Pharma is led by Executive Chairman, Lee Morley; Chief Executive Officer, Simon Ball; Chief Medical Officer, Dr Jonathan Morgan; and Chief Technical Officer, Debra Nevin. The Company’s founding team members are highly experienced with extremely relevant and proven track records across orphan disease states, antibody technologies, oncology and pediatric therapeutic areas.
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.
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