Biotechnology company Immutep (ASX:IMM)
has received a fast-track approval from the United States Food and Drug Administration (FDA) for its lead product ‘efti’.
The fast track designation will accelerate the approval of Efti which treats head and neck cancers. The designation is awarded to expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. This was given following the results from a Phase II trial presented in a data package.
The company specialises in development of LAG-3 immunotherapeutic products for cancer and autoimmune disease. Its lead product is eftilagimod alpha (efti), a soluble LAG-3Ig fusion protein based on the LAG-3.
The company will also work with Merck & Co in the USA on Phase IIb trial of efti with KEYTRUDA with its trial to commence mid this year.
Shares in Immutep (ASX:IMM)
are trading 14.77 per cent higher at $0.50.