Essential Pharma, a specialty pharma group has completed the acquisition of the entire issued share capital of Renaissance Pharma Ltd. Renaissance Pharma is a clinical stage pharmaceutical company focused on the development of life changing therapies in pediatric rare disease, with its lead asset being Hu14.18K322A (Hu14.18) – an immunotherapy currently in Phase II clinical development for the treatment of high-risk neuroblastoma (HRNB).
The acquisition adds a second product candidate to Essential Pharma’s rare disease portfolio and underlines the group’s strategy of seeking out clinically differentiated medicines in small patient populations. This will be Essential’s first clinical development-stage asset and is targeted at addressing significant unmet needs in pediatric oncology patients. Simon Ball, CEO and co-founder of Renaissance Pharma, who has significant scientific and commercial expertise within the space, will continue to work with Essential Pharma on Hu14.18’s development, as will many of the Renaissance Pharma team.
Neuroblastoma represents 7-10% of all childhood cancers and is the most common extracranial cancer in children and the most common cancer in children under one year of age12. Each year, more than 1500 people are diagnosed in Europe and 800 in the US23. Approximately half of all neuroblastoma patients have high risk (HRNB) disease which has an overall survival of ~50% over five years23. The current standard of care includes multiple cycles of chemotherapy, surgery, radiotherapy, stem cell transplantation and anti-GD2 monoclonal antibody (mAb) treatment2. There remains a significant unmet need in the availability of effective and suitable treatments for HRNB.
A Phase II trial incorporating Hu14.18 into first-line therapy and additionally, within post-consolidation therapy for HRNB patients, demonstrated positive patient outcomes with 3-year event-free survival (EFS) of 73.7% and overall survival (OS) of 86.0%. Data from this study was published in the Journal of Clinical Oncology in December 2021 and is approaching five-year OS readouts4.
Essential Pharma will work with St Jude Children’s Hospital in accordance with the exclusive license agreement that was signed between St Jude’s and Renaissance in 2023, in order to drive forward the development and commercialization of Hu14.18 across the territories licensed to Renaissance. Essential Pharma will be responsible for clinical development and defining the optimal route for regulatory approval and eventual commercial launch of Hu14.18.
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