FDA Grants Fast Track to Immutep’s Eftilagimod Alpha Combo for NSCLC

The FDA has granted a Fast Track designation to Immutep’s eftilagimod alpha in combination with pembrolizumab for treatment of first-line nonsmall-cell lung cancer (NSCLC).
Eftilagimod alpha targets LAG-3, a gene that codes a protein that is involved in the regulation of the immune system. It activates both the innate and adaptive immune system to target solid tumors.
The investigational drug offers a chemotherapy-free option for patients with NSCLC, the company said.
The drug has also received Fast Track status for the treatment of patients with first-line recurrent or metastatic head and neck squamous cell carcinoma.
About Immutep
Immutep Ltd (formerly Prima Biomed) is a biotechnology company working primarily in the field of cancer immunotherapy using the LAG3 immune control mechanism. The company was originally built on CVac, a therapeutic cancer vaccine. In late 2014 the privately held French immunotherapy company Immutep SA was purchased by Prima Biotech. Prima currently has three main products in its pipeline, all acquired with Immutep: Eftilagimod alpha, (lab name: IMP321) which is recombinant soluble LAG-3, used as an activator of antigen presenting cells. IMP731, a depleting monoclonal antibody for autoimmune diseases, targeting LAG-3+ activated T cells. This antibody has been licensed to GlaxoSmithKline. IMP701, an antagonist monoclonal antibody to LAG3 for use in cancer. This product has been licensed to Novartis.Headquarters Sydney, Australia, Leipzig, Germany.
October 6, 2022