Lorukafusp alfa

Essential Pharma announced on Tuesday that it acquired Renaissance Pharma for an undisclosed sum, gaining the latter's immunotherapy candidate, dubbed Hu14.18, which is in Phase II development for the treatment of high-risk neuroblastoma."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," remarked Essential CEO Emma Johnson. Hu14.18 "has already produced positive data in Phase II clinical trials, demonstrating a significant improvement in survival, and we are now committed to developing this immunotherapy to be able to bring it to market."A Phase II trial incorporating Hu14.18 into first-line therapy and within post-consolidation therapy for patients with high-risk neuroblastoma showed positive patient outcomes with 73.7% three-year event-free survival and 86% overall survival (OS). The trial is approaching the five-year OS readouts.Under the deal, Renaissance CEO Simon Ball will continue to work with Essential on the development of Hu14.18, as will many of the Renaissance team. Essential will work with St Jude Children’s Hospital in accordance with their 2023 exclusive license agreement to drive the development and commercialisation of Hu14.18 across the territories licensed to Renaissance. Essential will be responsible for clinical development of Hu14.18 along with defining the optimal route for regulatory approval and commercial launch of the immunotherapy.

Essential Pharma acquires Renaissance Pharma Ltd with its clinical stage immunotherapy for the treatment of high-risk neuroblastoma First development-stage asset to be added to the Essential Pharma portfolio and second product within rare disease Egham, UK – 9 April 2024 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, announces that it 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 paediatric 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 paediatric 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 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. Hu14.18 has enormous potential to help high risk neuroblastoma patients, the majority of whom are young children. It has already produced positive data in Phase II clinical trials, demonstrating a significant improvement in survival, and we are now committed to developing this immunotherapy to be able to bring it to market and to patients as quickly as possible.” 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.” About Essential Pharma Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche, branded medicines across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to multiple pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous and sustainable supply to patients. Essential Pharma is backed by Gyrus Capital, an investment firm dedicated to transformational investments in sectors with long-term sustainable growth, including healthcare. For more information, please visit essentialpharmagroup.com CONTACTS ICR Consilium Tracy Cheung/Chris Welsh/Isabelle Abdou Tel: +44 (0) 20 3709 5700 Email: Essentialpharma@consilium-comms.com 1 DuBois SG, Macy, ME, Henderson TO. High-Risk and Relapsed Neuroblastoma: Toward More Cures and Better Outcomes. American Society of Clinical Oncology Educational Book [Internet]. 2022 Jul;(42):768–80. Available from: 2 St. Jude Children’s Hospital. Neuroblastoma. Available from: 3 News Medical Life Sciences. European scientists target high-risk childhood cancer with liquid biopsy. Available from: 4 Furman WL, McCarville B, Shulkin BL, Davidoff A, Krasin M, Hsu CW, et al. Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. Journal of Clinical Oncology [Internet]. 2022 Feb 1;40(4):335–44. Available from: