RARE Daily

Renaissance Pharma Launches with License from St. Jude of Novel Antibody for High-Risk Neuroblastoma

August 1, 2023

Rare Daily Staff

Renaissance Pharma, a U.K.-based company focused on developing therapeutics for rare pediatric diseases, launched with 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 to 10 percent of all childhood cancers, is the second most common cancer in children and is the most common cancer in children under one year of age. Fifty percent of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of approximately just more than 5 years. Each year more than 500 HRNB patients are diagnosed in Europe and 300 in the United States. The current standard of care includes multiple cycles of chemotherapy, surgery, radiotherapy, stem cell transplantation and anti-GD2 monoclonal antibody treatment.

Hu14.18 is an anti GD2 humanized monoclonal antibody. A novel phase 2 trial incorporating Hu14.18 into induction therapy and additionally, within post-consolidation therapy, demonstrated outstanding patient outcomes with overall survival of 86 percent and event-free survival of 73.7 percent. Within the patient population, where antibody was used in all patients prior to consolidation and maintenance, 66.7 percent achieved a partial response or better after the first two chemo-immunotherapy induction cycles, and 96.8 percent achieved a partial response or better at the end of induction.

Data from the successful phase 2 study was published in the Journal of Clinical Oncology in December 2021 and will soon reach maturity in regard to its five-year overall survival readouts.

Under the terms of the licensing agreement, Renaissance Pharma has secured exclusive development, manufacturing and commercialization rights in the United States, 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.

“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,” said Simon Ball, CEO of Renaissance Pharma. “Renaissance Pharma now has its full attention on bringing this humanized 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.”

Photo: Simon Ball, CEO of Renaissance Pharma

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