Advesya Granted EMA Clinical Trial Application (CTA) for CCTx-001, Its Lead Investigational Cell Therapy Asset Targeting IL-1RAP for the Treatment of Relapsed/Refractory Acute Myeloid Leukaemia
Paris – July 29th 2024 – Advesya, a pioneering biopharma company focusing on targeting IL-1RAP for the treatment of difficult-to-treat cancers today announces that it has received approval from the European Medicines Agency (EMA) to commence the phase 1/2 trial of CCTx-001, its lead investigational asset. CCTx-001 is an autologous chimeric antigen receptor T-cell (CAR T) therapy directed against human interleukin-1 receptor associated protein (IL-1RAP) that is highly and specifically expressed in leukemic and blast cells of patients with acute myeloid leukemia.
Following EMA’s approval, Advesya will launch its adaptive phase 1/2 study (RESOLVE-AML-001 [NCT06281847]) to determine the recommended phase 2 dose of CCTx-001 and to assess safety, tolerability, and clinical activity in patients with relapsed/refractory acute myeloid leukemia (AML). AML is a type of blood cancer that originates from early blood-forming cells in the bone marrow that replace normal bone marrow cells, abolishing blood cells formation. Treatment typically involves chemotherapy and targeted therapies, and allogeneic hematopoietic stem cell transplantation.
Jens Hasskarl, Chief Medical Officer of Advesya, commented: “The successful transition from academic pre-clinical science to a clinical stage company is a key milestone for Advesya. It confirms the potential of our lead candidate that has already demonstrated very promising pre-clinical results. Our differentiated cell therapy approach to target IL-1RAP has the potential for unprecedented efficacy and, in some cases, to cure hard-to-treat haematological cancers, benefitting patients with high unmet needs. ”
About Advesya: Advesya was founded in 2021 by two experienced scientists, Christophe Ferrand and Marina Deschamps, from the French Blood Institute (EFS) in Besançon (France) who decided to spin off their CAR T-cell research on IL-1RAP into a new company. Supported by Jeito Capital since 2022, Advesya has developed a differentiated and unique pipeline targeting the IL-1RAP pathway to address the medical needs of patients with haematological and solid malignancies as well as autoimmune diseases.
