Priority Medicines (PRIME) designation supports the potential for lacutamab to benefit Sézary Syndrome patients in need of new treatment options
Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") today announced that the European Medicines Agency (EMA) has granted PRIME designation to lacutamab, the Company’s proprietary first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, for the treatment of patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies.
The PRIME designation is based on efficacy data in relapsed or refractory SS patients from the completed Phase 1 dose escalation and expansion trial, and is supported by safety data in SS patients from both the Phase 1 trial and ongoing Phase 2 TELLOMAK clinical trial. This is the first time PRIME designation has been granted for a potential treatment of any sub-type of T-cell lymphoma.
"We are pleased that the EMA has granted PRIME designation for lacutamab, as Sézary syndrome is the most aggressive form of cutaneous T-cell lymphoma and patients facing advanced disease are in great need of new, targeted treatment options,” said Joyson Karakunnel, MD, Msc, FACP, Executive Vice President and Chief Medical Officer, Innate Pharma. “Lacutamab is an important asset for our Company, and this designation further validates our work to deliver this potentially first-in-class treatment to patients as quickly as possible.”
PRIME designation by the EMA supports the development of promising new medicines that target an unmet medical need. It allows for proactive support from the EMA throughout the clinical development process and enables accelerated assessment. Lacutumab was also awarded Fast Track designation by the U.S. Food and Drug Administration in 2019 for the treatment of adult patients with relapsed or refractory SS who have received at least two prior systemic therapies.