FDA awards Ilixadencel 'orphan drug' for treatment of hepatocellular carcinoma (HCC)

Hepatocellular carcinoma (HCC) is the most common type of chronic liver cancer in adults and is the most common cause of death in patients with cirrhosis.
it occurs in an environment of chronic liver inflammation and is highly associated with exposure to chronic viral hepatitis infections (hepatitis B or C), alcohol or toxins such as jaundols.
, a pharmaceutical company, recently announced that the U.S. Food and Drug Administration (FDA) has awarded Ilixadencel the "Orphan Drug Title" (ODD) for the treatment of hepatocellular carcinoma (HCC).
company's main drug, ilixadencel, is a cell-based immune product used to treat hepatocellular carcinoma (HCC).
the latest results of this approved Phase I/II clinical trial based on iixadencel therapy that cannot be removed and/or metastasis HCC.
lixadencel is an allogeneic degenerative cell (DC) therapy that has been developed as a generic (off-the-shelf) cancer immune primer, which is injected in-tumor for the treatment of multiple solid tumors.
active ingredient in ilixadencel is degenerate cells (DCs) from healthy blood donors, which are particularly activated and produce a large number of powerful immune stimuli.
Intransiology, these cells cause a local inflammatory response, recruiting and inflaming the patient's own DC cells and natural killer cells (NK) into the tumor environment, destroying the tumor cells and releasing a full set of tumor-specific proteins, neoantigen.
these new antigens will serve as a source of antigens, leading to tumor-specific activation of patients' cytotoxic T cells, especially cytotoxic CD8-T cells, resulting in a highly individualized, powerful anti-tumor response.
Based on the broad potential of ilixadencel in a variety of solid tumor adaptations, we will continue our efforts for further clinical development," said Sven Rohmann, M.D., chief executive of Immunicum.
May 2020, Immunicum received the Ilixadencel Advanced Therapy for Regenerative Medicine (RMAT) title from the FDA for the treatment of patients with metastatic renal cell carcinoma.
December 2020, Immunicum announced that it had been awarded a fast-track designation by the FDA for ilixadencel as a treatment for gastrointestinal mesothelioma (GIST).
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