Posted: 7 August 2023
Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the continued development of eftilagimod alpha (efti), the Company’s soluble LAG-3 protein and first-in-class MHC Class II agonist.
In May 2023, Immutep requested scientific advice from the EMA regarding future development of efti, and in particular whether further toxicity studies would be required before the Company could seek marketing authorisation for efti in Europe. Based on the available clinical data and acknowledgement that additional studies in animal models are unlikely to provide relevant information, the CHMP advised that further toxicology studies are not needed for a future Marketing Authorisation Application (MAA). Similar advice was received from the US Food and Drug Administration (FDA) as it relates to a potential future Biologics License Application (BLA).
Immutep continues to be encouraged with its constructive interaction with regulatory agencies regarding its expanding late-stage clinical pipeline with efti. As recently reported, Immutep has also received positive feedback from the FDA regarding the upcoming TACTI-004 Phase III trial in 1st line non-small cell lung cancer as well as for the AIPAC-003 Phase II/III trial in metastatic breast cancer, which began dosing patients during the second quarter of CY2023.
