Hu14.18K322A

Press Release Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma Renaissance Pharma announces its first development program focused on Hu14.18, a humanised anti-GD2 monoclonal antibody, licensed from St. Jude Children’s Research Hospital for the treatment of newly diagnosed high-risk neuroblastomaA novel key Phase II trial incorporated the addition of Hu14.18 antibody to standard induction chemotherapy and demonstrated outstanding outcomes in patients with newly diagnosed high-risk neuroblastoma with a 3-year event-free (EFS) and overall survival (OS) of 73.7% and 86.0% respectivelyRenaissance will now pursue interaction with the FDA and EMA together with other regulatory agencies around the globe to develop the optimal path to submissionCompany led by an Executive Team with extensive relevant experience in development, approval and commercialisation of oncology and rare disease products August 01, 2023 (Manchester, UK) – Renaissance Pharma Ltd., (“Renaissance” or “the Company”), a rapidly emerging company focused on the development of life changing therapies in paediatric rare disease, today launches and announces the signing of an exclusive license agreement with St. Jude Children’s Research Hospital (“St. Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma. Neuroblastoma represents 8-10% of all childhood cancers1, is the second most common cancer in children and is the most common cancer in children under one year of age2. 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over 5 years3. Each year more than 500 HRNB patients are diagnosed in Europe and 300 in the US. The current standard of care includes multiple cycles of chemotherapy, surgery, radiotherapy, stem cell transplantation and anti-GD2 monoclonal antibody (mAb) treatment. Hu14.18 is an anti GD2 humanised mAb. A novel Phase II trial incorporating Hu14.18 into induction therapy and additionally, within post-consolidation therapy, demonstrated outstanding patient outcomes with OS of 86.0% and EFS of 73.7%4. Within the patient population, where antibody was used in all patients prior to consolidation and maintenance, 66.7% achieved a Partial Response or better after the first two chemo-immunotherapy induction cycles, and 96.8% achieved a Partial Response or better at the end of induction. Data from the successful Phase II study was published in the Journal of Clinical Oncology in December 2021 and will soon reach maturity in regard to its 5-year OS readouts5. Renaissance Pharma, launched today, is led by Executive Chairman, Lee Morley; Chief Executive Officer, Simon Ball; Chief Medical Officer, Dr Jonathan Morgan; and Chief Technical Officer, Debra Nevin. The Company’s founding team members are highly experienced with extremely relevant and proven track records across orphan disease states, antibody technologies, oncology and paediatric therapeutic areas. Under the terms of the licensing agreement, Renaissance Pharma has secured exclusive development, manufacturing and commercialisation rights to US, 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. Lee Morley, Executive Chairman of Renaissance Pharma, said: “We couldn’t be more motivated by the prospect of bringing Hu14.18 to patients. The Phase II data as published in the Journal of Oncology is breathtaking and I am certain that the neuroblastoma community will be as excited as we are when considering the potential significance of this breakthrough treatment. Our responsibility is now to continue the journey that St. Jude so professionally began. Our intent is simple, to get Hu14.18 into the hands of treating physicians as swiftly as possible so the potential benefits Hu14.18 offers can be passed on to the patients that so desperately need them. This responsibility begins immediately.” Simon Ball, CEO of Renaissance Pharma, said: “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. Renaissance Pharma now has its full attention on bringing this humanised 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.” “It is exciting and deeply meaningful to see how our clinical efforts to develop Hu14.18 may now have the potential to positively impact patients with high-risk neuroblastoma around the world,” said Sara M. Federico, MD, St. Jude Department of Oncology. -Ends- 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 providing 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 Officerinfo@renaissancepharma.co.uk International media Consilium Strategic Communications Mary-Jane Elliott, Chris Welsh, Lucy Featherstone renaissance@consilium-comms.com 1 Park, J.R., Eggert, A. and Caron, H., 2010. Neuroblastoma: biology, prognosis, and treatment. Hematology/oncology clinics of North America, 24(1), pp.65-86.2 Cancer.Net, Neuroblastoma–Childhood, [https://www.cancer.net/cancer-types/neuroblastoma-childhood], Accessed 18/07/2023.3 Cancer.Net, Neuroblastoma–Childhood, [https://www.cancer.net/cancer-types/neuroblastoma-childhood], Accessed 18/07/2023.4 Furman, W.L., McCarville, B., Shulkin, B.L., Davidoff, A., Krasin, M., Hsu, C.W., Pan, H., Wu, J., Brennan, R., Bishop, M.W. and Helmig, S., 2022. 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, 40(4), pp.335-344.5 Furman, W.L., McCarville, B., Shulkin, B.L., Davidoff, A., Krasin, M., Hsu, C.W., Pan, H., Wu, J., Brennan, R., Bishop, M.W. and Helmig, S., 2022. 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, 40(4), pp.335-344.