Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC)

Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC)

Immunicum AB (publ; IMMU.ST) announced today that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of Hepatocellular Carcinoma (HCC). The designation was based on data from a Phase I/II clinical trial of ilixadencel in patients with unresectable and/or metastatic HCC. The Orphan Drug Act was enacted in the United States to support the development of new drugs and biologics for rare diseases through financial incentives, such as partial tax credit for clinical trial costs, and up to seven years of market exclusivity upon regulatory product approval.

“Our efforts to secure the most advantageous conditions for the further clinical development of ilixadencel based on its broad potential in a range of solid tumor indications continue to be successful,” said Sven Rohmann, M.D., Ph.D., CEO of Immunicum. “As we become a fully-integrated biopharmaceutical company and further define our plans for ilixadencel’s path toward commercialization, it is valuable to complement this year’s Fast Track and RMAT designations with today’s FDA Orphan Drug Designation.”

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 as a treatment for Gastrointestinal Stromal Tumors (GIST).

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