Immutep Limited (NASDAQ:IMMP) rose sharply in Thursday trading. Immutep shares gained 5% on Wednesday after the company announced the grant of patent number EP3317301 entitled "Combination therapies comprising antibody molecules to LAG-3" by the European Patent Office.
Thursday morning brought with it news that its lead product candidate eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3 protein, has received Fast Track designation in first-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 first-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.
In mid-March, Immutep announced that it had entered into a second collaboration with Merck & Co. to evaluate efti in combination with KEYTRUDA in a new Phase IIb trial in first-line HNSCC, TACTI-003.
IMMP shares gathered 24 cents, or 7.4%, first thing Thursday, to $3.42.
