April 9, 2024

Essential Pharma acquires Renaissance Pharma Ltd with its clinical stage immunotherapy for the treatment of high-risk neuroblastoma

April 9, 2024 (UK) – 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.

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 age1,2. Each year, more than 1500 people are diagnosed in Europe and 800 in the US2,3. Approximately half of all neuroblastoma patients have high risk (HRNB) disease which has an overall survival of ~50% over five years2,3. 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 Renaissance Pharma Ltd.

Renaissance Pharma was established in 2023 by Executive Chairman, Lee Morley, and Chief Executive, Simon Ball. The Company’s vision is to provide breakthrough therapeutic improvements in rare paediatric diseases. Initially, the Company’s sole focus will be on expediting the development of Hu14.18 for treatment of newly diagnosed high-risk neuroblastoma. Renaissance is based in Manchester, UK and backed by a consortium of international healthcare investors led by the Company’s leadership team. 

About St. Jude Children’s Research Hospital 

St. Jude Children's Research Hospital is leading the way the world understands, treats and cures childhood cancer, sickle cell disease, and other life-threatening disorders. It is the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children. Treatments developed at St. Jude have helped push the overall childhood cancer survival rate from 20% to 80% since the hospital opened more than 60 years ago. St. Jude shares the breakthroughs it makes to help doctors and researchers at local hospitals and cancer centers around the world improve the quality of treatment and care for even more children. To learn more, visit stjude.org, read St. Jude Progress blog, and follow St. Jude on social media at @stjuderesearch.

For more information please contact:

Renaissance Pharma

Simon Ball, Chief Executive Officer
info@renaissancepharma.co.uk

  • On March 22, 2024, Renaissance Pharma Ltd was purchased by Essential Pharma to facilitate and stimulate an expansion into rare disease medicine

  • The acquisition adds a second product to Essential Pharma’s rare disease portfolio.

  • Simon Ball, CEO and co-founder of Renaissance Pharma, will continue to work with Essential Pharma on the development of Hu14.18’s, as will many of the Renaissance Pharma team.

  • 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, to drive forward the development and commercialisation of Hu14.18 across the territories licensed to Renaissance.

PRESS RELEASE

References

  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: http://dx.doi.org/10.1200/edbk_349783

  2. St. Jude Children’s Hospital. Neuroblastoma. Available from: https://www.stjude.org/disease/neuroblastoma.html

  3. News Medical Life Sciences. European scientists target high-risk childhood cancer with liquid biopsy. Available from: https://www.news-medical.net/news/20240129/European-scientists-target-high-risk-childhood-cancer-with-liquid biopsy.aspx#:~:text=Neuroblastoma%20mainly%20affects%20toddlers%20and,patients%20are%20high%2Drisk%20cases

  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: http://dx.doi.org/10.1200/jco.21.01375