XNK Therapeutics has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its 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 the drug candidate, states the company. 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,” says 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.”
Completed Phase I/II clinical trial
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 good safety profile, and promising efficacy data, states the company.
XNK Therapeutics is continuing the clinical development in multiple myeloma in Europe and plans to initiate a Phase II clinical trial in the near future.