Immunicum has been granted an Orphan Drug Designation (ODD) for ilixadencel in the treatment of Gastrointestinal Stromal Tumors (GIST).
This designation confirms the need and potential for ilixadencel as a new treatments for patients with GIST, which is a rare and difficult to treat subgroup of cancers reffered to as Soft Tissue Sarcoma (STS), states the company.
“We continue to interact with agencies on development of treatments for hard-to-treat tumors,” says Jeroen Rovers, Chief Medical Officer at Immunicum. “This ODD will support further development of ilixadencel, including a Phase II trial which Immunicum is currently preparing with ilixadencel in combination with tyrosine kinase inhibitors in GIST.”
In January 2021, Immunicum received ODD from the FDA for ilixadencel for treatment of STS. In December 2020, Immunicum announced that it received Fast Track Designation from the U.S. FDA for ilixadencel in GIST.
Photo of Jeroen Rovers: Immunicum