Immutep Limited announces FDA Orphan Drug Designation for eftilagimod alfa in treating Soft Tissue Sarcoma, providing regulatory benefits and recognizing encouraging Phase II trial data.
Key takeaways
FDA granted Orphan Drug Designation for eftilagimod alfa (efti) in Soft Tissue Sarcoma (STS), a rare cancer.
ODD benefits include regulatory support, potential tax credits, fee exemptions, and seven years market exclusivity upon approval.
EFTISARC-NEO Phase II trial met primary endpoint with median tumour hyalinization/fibrosis of 51.5% in 38 patients, exceeding 35% target and historical 15% benchmark.
Trial combined efti with radiotherapy and KEYTRUDA in neoadjuvant setting for resectable STS, showing immune activation and favorable safety.
Company reviewing Phase III TACTI-004 discontinuation, with ODD supporting potential late-stage neoadjuvant STS study.