Immutep (NASDAQ:IMMP) shares jumped sharply on Wednesday after the company announced that the U.S. Food and Drug Administration had granted Orphan Drug Designation (ODD) to eftilagimod alfa.
Eftilagimod alfa is being developed as a treatment for soft tissue sarcoma (STS), a rare and complex group of cancers that arise in connective tissues such as muscle, fat, nerves and blood vessels.
The FDA awarded the designation in recognition of the significant unmet medical need in STS. Immutep said the decision also highlights the therapeutic potential of eftilagimod alfa in this indication, supported by encouraging results from its Phase II EFTISARC-NEO study.
The trial assessed the treatment in combination with radiotherapy and KEYTRUDA, providing positive clinical data in patients with soft tissue sarcoma.
Marc Voigt, CEO of Immutep, said, “We are pleased that the FDA has recognised the potential of efti for patients with soft tissue sarcoma, a rare and difficult to treat cancer. As previously communicated, the Company is currently undertaking a comprehensive review and analysis following the discontinuation of its Phase III TACTI-004 trial and the outcome will influence the decision regarding any potential future clinical trial with efti.”