The European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on the company’s application for orphan designation status for its Phase II clinical candidate, ilixadencel, for the treatment of Gastrointestinal Stromal Tumors (GIST).

The COMP opinion was based on results from the Phase I/II clinical trial in GIST, a rare and difficult-to treat cancer indication belonging to the group of cancers referred to as soft tissue sarcomas (STS).

“The Orphan Drug Designations awarded by both the EMA and the FDA for ilixadencel in the GIST indication represent an important step forward for Immunicum,” states Sven Rohmann, CEO of Immunicum in the company’s press release. “They open up an important regulatory pathway and provide us with the potential to rapidly and independently advance ilixadencel toward commercialization in a small patient population. We look forward to executing on our goal of providing new treatment options to GIST patients.”

Development of ilixadencel

In May 2020, Immunicum received Regenerative Medicine Advanced Therapy designation from the FDA for ilixadencel for the treatment of patients with metastatic Renal Cell Carcinoma. In December 2020, Immunicum announced that it received Fast Track Designation from the FDA for ilixadencel in Gastrointestinal Stromal Tumors (GIST) and Orphan Drug Designation by the FDA for ilixadencel in hepatocellular carcinomas. In January of this year, the company announced FDA Orphan Drug Designation for ilixadencel in STS.

Photo of Sven Rohmann: Immunicum
Source: Immunicum press release