Immutep announces completion of FDA Project Optimus requirements

Immutep (IMMP) announces that positive and straightforward feedback has been received from the US Food and Drug Administration, FDA, regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa. Immutep’s Chief Development Officer, Christian Mueller, said, “We are very thankful for the FDA’s positive feedback and productive discussions over the past few years. The alignment on efti’s optimal biologic dose has strategic relevance to our efti oncology programs and is a major de-risking event and building block towards future BLA filings. We are excited to successfully conclude this chapter of efti’s clinical development and are intently focused on bringing this novel immunotherapy to market to help address the needs of cancer patients worldwide.”