Immutep Limited (NASDAQ: IMMP) announced the U.S. Food and Drug Administration granted Orphan Drug Designation for eftilagimod alfa in treating soft tissue sarcoma, a rare cancer.

The FDA's Orphan Drug Designation program supports development of therapies for rare diseases affecting fewer than 200,000 people in the United States. The designation provides regulatory support, potential tax credits, fee exemptions, and seven years of market exclusivity upon approval.

The designation follows clinical data from the Phase II EFTISARC-NEO trial evaluating eftilagimod alfa combined with radiotherapy and pembrolizumab in patients with resectable soft tissue sarcoma. In 38 evaluable patients, the study achieved its primary endpoint with median tumor hyalinization/fibrosis of 51.5%, exceeding the target of 35% and historical benchmarks of approximately 15% with radiotherapy alone.

The results occurred across multiple sarcoma subtypes with translational data showing immune activation consistent with the drug's mechanism of action, according to the company's statement.

CEO Marc Voigt said the designation provides "a potential direct step forward into a late-stage study in the neoadjuvant setting for STS." The company is conducting a review following discontinuation of its Phase III TACTI-004 trial, which will influence decisions regarding future clinical trials with eftilagimod alfa.

Immutep is a clinical-stage biotechnology company developing immunotherapies for cancer and autoimmune diseases. The company focuses on therapeutics related to Lymphocyte Activation Gene-3 (LAG-3).