Immutep Limited (IMMP) Receives FDA Orphan Drug Designation for Efti in Soft Tissue Sarcoma

We recently compiled a list of the 8 Oversold Biotech Stocks to Invest In Now. Immutep Limited is among the oversold stocks to invest in now.

TheFly reported on April 15 that  IMMP announced that the U.S. Food and Drug Administration granted Orphan Drug Designation to eftilagimod alfa (efti) for the treatment of Soft Tissue Sarcoma, which is a rare cancer with limited treatment options. The designation is intended to support development of therapies for diseases affecting fewer than 200,000 patients in the United States and may provide incentives such as regulatory assistance, fee reductions, tax benefits, and potential market exclusivity after approval.

The decision was supported by data from the Phase II EFTISARC-NEO study, where 38 evaluable patients showed a median tumour hyalinization/fibrosis rate of 51.5%, exceeding the predefined 35% goal and historical results of around 15% with radiotherapy alone. The study also showed immune activation consistent with the drug’s mechanism and maintained a favorable safety profile without delaying surgery.

Additionally, talking about developments, earlier on March 19, Immutep Limited (NASDAQ:IMMP) announced that the single ascending dose phase of its Phase I trial for IMP761, a first-in-class LAG-3 agonist for autoimmune conditions, was completed. Doses reached 14 mg/kg, with the study showing good tolerability and no safety issues or dose-limiting toxic effects observed.

Immutep Limited (NASDAQ:IMMP) is a clinical-stage biotechnology company developing LAG-3–based immunotherapies for cancer and autoimmune diseases. It focuses on immune system modulation using its lead candidate eftilagimod alfa and has a pipeline of oncology and immunology drugs.

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