XNK Therapeutics announced it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its leading investigational drug candidate in the treatment of multiple myeloma (MM).

Receiving ODD status from the FDA for the treatment of multiple myeloma is a critical next step for the development of XNK’s leading investigational drug candidate. XNK has already received ODD status in the EU.

“Obtaining an ODD by the FDA is a significant milestone for XNK and our goal of taking the present drug candidate to the next level,” said Johan Liwing, CEO of XNK Therapeutics. “This is the starting point for us to expand clinical development into the most important market globally for cancer treatment.”

XNK has already completed its first-in-human Phase I/II clinical trial (ACP-001) in multiple myeloma at the Karolinska University Hospital in Stockholm, Sweden, showing a very good safety profile, and promising efficacy data. The company is continuing the clinical development in multiple myeloma in Europe and plans to initiate a Phase II clinical trial in the near future.

XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologous NK cell-based products using its proprietary technology platform.

The company’s platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow’s cancer treatment strategies.