Australian clinical-stage biotechnology company Immutep (ASX:IMM) says it has received positive scientific advice from the European Medicines Agency (EMA) for the continued development of its soluble LAG-3 protein and first-in-class MHC Class II agonist, eftilagimod alpha.
In May 2023, the company requested scientific advice from the EMA regarding the future development of efti, particularly whether further toxicity studies would be required before it could seek marketing authorisation for efti in Europe.
Based on the available clinical data and the acknowledgement that additional studies in animal models are unlikely to provide relevant information, the EMA advised that further toxicology studies are unnecessary for a future Marketing Authorisation Application. Similar advice was received from the US FDA regarding a potential future Biologics License Application (BLA).
Immutep said it continues to be encouraged by its constructive interaction with regulatory agencies regarding its expanding late-stage clinical pipeline with efti.
As recently reported, the company has also received positive feedback from the FDA regarding the upcoming TACTI-004 Phase 3 trial in first-line non-small cell lung cancer as well as for the AIPAC-003 Phase I2/3 trial in metastatic breast cancer, which began dosing patients during the second quarter of the calendar year 2023.