FDA fast track designation for Immutep's 'efti'

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Immutep (ASX:IMM), which is developing novel immunotherapy treatments for cancer, infectious disease and autoimmune disease, has announced that the US FDA has granted fast-designation to its lead product candidate eftilagimod alpha (efti).

The designation is in the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Fast track designation is designed to help new therapies with a potentially significant impact to reach patients earlier. There is a significant unmet medical need for new treatments for HNSCC.

"The data package evaluated by the FDA included the promising results from Part C of Immutep’s Phase II TACTI-002 trial evaluating efti in combination with [MSD] KEYTRUDA (pembrolizumab) 2nd line PD-X naive HNSCC, and its plans for a trial in 1 st line HNSCC (TACTI-003)," said the company.

Immutep recently announced it had entered a second collaboration with MSD to evaluate efti in combination with KEYTRUDA in a new Phase IIb trial (TACTI-003) in first-line HNSCC.