Immutep achieves FDA Fast Track designation for soluble LAG-3 protein
Immutep, a biotechnology company developing novel immunotherapy treatments for cancer, infectious disease, and autoimmune disease, has achieved FDA Fast Track designation for its candidate eftilagimod alpha (efti), to be used as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Efti, a soluble LAG-3 protein, has been granted the Fast Track designation based upon its potential to address an unmet medical need, as evidenced by presented 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(R) (pembrolizumab) as a second-line treatment for 28 PD-X naive HNSCC patients, alongside its plans for a trial into the first-line treatment of HNSCC (TACTI-003).
Frédéric Triebel, MD, PhD, Chief Scientific Officer and Chief Medical Officer of Immutep, said: “The results from this trial, and our other trials, continue to support our hypothesis that the combination of our lead product candidate, [eftilagimod alpha], with a PD-1 inhibitor such as pembrolizumab should result in a meaningful benefit to patients across various cancers.”
Efti binds to a subset of MHC class II molecules to mediate antigen-presenting cells and CD8 T-cell activation. Investigators hypothesised that the stimulation of the dendritic cell network and subsequent T cell recruitment could lead to stronger antitumour responses when used in combination with pembrolizumab vs pembrolizumab alone.
FDA Fast Track designation is awarded to help important new therapies reach patients earlier. It is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.
Immutep will now have access to more frequent meetings and communications with the FDA, potentially receive Rolling Review of its Biologic License Application (once submitted), and may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met, for efti in HNSCC.
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