Immutep Limited (IMMP) announced that the U.S. FDA has granted Orphan Drug Designation for its immunotherapy candidate Eftilagimod alfa ("efti") for the treatment of soft tissue sarcoma, a rare cancer with significant unmet medical need.
Soft tissue sarcoma (STS) affects fewer than 200,000 people in the U.S. and is often difficult to treat. The FDA's ODD program provides incentives such as regulatory support, potential tax credits, fee exemptions, and seven years of market exclusivity upon approval.
The designation was supported by encouraging results from the Phase II EFTISARC-NEO trial, which evaluated efti in combination with radiotherapy and KEYTRUDA (pembrolizumab) in patients with resectable STS. In 38 evaluable patients, the study met its primary endpoint, showing a median tumor hyalinization/fibrosis of 51.5%- well above the pre-specified target of 35% and historical benchmark of ~15% with radiotherapy alone. The therapy also demonstrated immune activation consistent with efti's mechanism of action, alongside a favorable safety profile and no delays to surgery.
"We are pleased that the FDA has recognized the potential of efti for patients with soft tissue sarcoma, a rare and difficult to treat cancer," said Marc Voigt, CEO of Immutep. He noted that the designation provides a potential direct step forward into a late-stage study in the neoadjuvant setting for STS.
IMMP has traded between $0.29 and $3.53 over the past year. The stock is currently trading at $0.60, up 93.01%.
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