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- Immutep Ltd’s (ASX:IMM) lead product candidate eftilagimod alpha or efti has received fast track designation from the United States Food and Drug Administration (FDA).
- Immutep develops novel immunotherapy treatments for cancer, infectious and autoimmune diseases.
Global biotechnology company Immutep Ltd (ASX:IMM) on Thursday announced that its lead product candidate eftilagimod alpha or efti had received fast track designation from the United States Food and Drug Administration (FDA).
Efti, a soluble LAG-3 protein, has received fast track designation in 1st line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Immutep develops novel immunotherapy treatments for cancer, infectious and autoimmune diseases.
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What FDA evaluated
According to the company update released earlier on Thursday, 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 1st 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 per cent for 28 patients receiving efti in combination with KEYTRUDA.
On 16 March 2021, Immutep announced that it had entered in a second collaboration with MSD to evaluate efti in combination with KEYTRUDA in a new Phase IIb trial in 1st line HNSCC, TACTI-003. The company said that the planning for this trial was advancing well and the study is expected to start in mid-2021.
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Shares of Immutep closed at A$0.44, up 3.53 per cent on Wednesday, 7 April 2021, as against the previous closing on Tuesday, 6 April 2021. The stock has given a return of 4.5 per cent so far this year.