Immunicum has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for ilixadencel.
Ilixadencel is a cell-based, off-the-shelf immune primer, for the treatment of Soft Tissue Sarcoma (STS). The designation recognizes results from the Phase I/II clinical trial in Gastrointestinal Stromal Tumors (GIST), a rare and difficult-to treat cancer indication belonging to the group of cancers referred to as Soft Tissue Sarcoma.
“We continue to build recognition for ilixadencel’s potential and are pleased to announce that in addition to designations for ilixadencel in Renal Cell Carcinoma and Hepatocellular Carcinoma, we have now received Orphan Drug Designation by the FDA for the treatment of Soft Tissue Sarcoma, which includes GIST,” says Sven Rohmann, CEO of Immunicum. “GISTs are highly resistant to conventional radio- and chemotherapy and receiving the designation based on the positive data from our Phase I/II clinical trial provides additional momentum for our pipeline as well as encourages us to bring ilixadencel to patients as rapidly as possible.”
“In addition to designations for ilixadencel in Renal Cell Carcinoma and Hepatocellular Carcinoma, we have now received Orphan Drug Designation by the FDA for the treatment of Soft Tissue Sarcoma, which includes GIST.”
Orphan Drug Designation may allow Immunicum to be eligible for a seven-year period of U.S. Marketing exclusivity upon approval of ilixadencel and a waiver of the Prescription Drug User Fee Act (“PDUFA”) filing fees, subject to certain conditions.
In May 2020, Immunicum received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for ilixadencel to be used for treatment of patients with metastatic Renal Cell Carcinoma. In December 2020, Immunicum announced that it received Fast Track Designation from the U.S. FDA for ilixadencel in Gastrointestinal Stromal Tumors (GIST).
Photo (right): Sven Rohmann, CEO, Immunicum