Essential Pharma Acquires Renaissance, Expands Rare Disease Portfolio

• Essential Pharma has acquired Renaissance Pharma, adding a second product candidate to its rare disease portfolio.

• Renaissance Pharma’s lead asset, Hu14.18, is an immunotherapy currently in Phase II clinical development for high-risk neuroblastoma (HRNB).

• Essential Pharma will work with St Jude Children’s Hospital to drive forward the development and commercialization of Hu14.18.

Essential Pharma, an international specialty pharma group, has completed the acquisition of the entire issued share capital of Renaissance Pharma Ltd., a clinical stage pharmaceutical company focused on the development of life-changing therapies in pediatric rare disease. This 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.

Renaissance Pharma’s lead asset is Hu14.18K322A (Hu14.18) – an immunotherapy currently in Phase II clinical development for the treatment of high-risk neuroblastoma (HRNB). 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. 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%.

Essential Pharma will work with St Jude Children’s Hospital per the exclusive license agreement that was signed between St Jude’s and Renaissance in 2023, in order to drive forward the development and commercialisation 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.

Emma Johnson, CEO of Essential Pharma, commented: “Our acquisition of Hu14.18, the group’s second product for treatment of a rare disease, and the first development-stage asset in our portfolio, is a significant milestone for Essential Pharma, demonstrating our commitment to enabling access to clinically-differentiated medicines.” Lee Morley, Executive Chairman, Renaissance Pharma Ltd, and Non-Executive Director, Essential Pharma, said: “Essential Pharma is the right partner to take Hu14.18 forward. Having worked alongside Emma at EUSA Pharma, a company specialising in oncology and rare disease, I know that she and the Essential Pharma team have the experience and expertise to bring this important product to market and make it available for children with high-risk neuroblastoma.”