ATMP Oncology Study: The first-in man trial for a Biotech’s novel therapy to prime the patient’s natural killer cells to attack their cancer

Case Study – Cell Therapy Clinical Trial

PHARMExcel was approached by global biotech, INmune Bio, to manage its UK/EU Phase I open label dose, escalation study of intravenous NK cell-targeted therapy in patients with high-risk Myelodysplastic Syndrome (MDS) and Acute Myelocytic Leukemia (AML).

Despite the hurdles COVID-19 pandemic created, PHARMExcel worked closely with the regulators to obtain site approval quickly. The trial eligibility criteria also posed several challenges, but by working closely with the sites we minimized any risk of delaying the sites’ opening. Our expertise in complex ATMP regulatory processes ensured full regulatory compliance.

• Prof Mark Lowdell, CSO at INmune Bio Inc and Professor of Cell & Tissue Therapy, UCL, UK.
• Clinical team at Southampton University, UK, led by Dr Kim Orchard, past president of the British Society of Blood and Marrow Transplantation and Cellular Therapy.
• Dr Chris Dalley, Consultant Haematologist and Bone Marrow Transplant Physician, Southampton Hospital.

As a trial development partner PHARMExcel has the ability to adapt to biotech needs, providing expertise, ISO 9001 certified operational infrastructure and the relevant scalable services where needed.