Immutep Achieves Fast Track Designation From US FDA For Efti, A Soluble Lag-3 Protein, In First Line Recurrent/Metastatic Head & Neck Cancer

Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer, infectious disease and autoimmune disease, announces its lead product candidate eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein, has received Fast Track designation in 1^st line recurrent or metastatic HNSCC from the United States Food and Drug Administration (FDA).

Fast Track has been granted for the development program of efti for 1^st line treatment of recurrent or metastatic HNSCC due to its potential to address an unmet medical need, as evidenced by encouraging data indicating a positive risk benefit ratio.

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 KEYTRUDA® (pembrolizumab) 2nd line PD-X naive HNSCC, and its plans for a trial in 1^st line HNSCC (TACTI-003).  Interim clinical data from TACTI-002 was presented at the Society for Immunotherapy of Cancer (SITC) in November 2020. The Overall Response Rate (ORR) reported at SITC was approximately 36% (approximately 44% in evaluable patients) for 28 patients receiving efti in combination with KEYTRUDA.

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