New cell therapy! The FDA grants the same allogeneic active degeneration degeneration cell iixadencel orphan drug qualification for the treatment of soft tissue sarcoma (STS)!

28, 2021 /// -- Immunicum AB, a Swedish biotechnology company dedicated to the development of isomer, idiopathic cell therapies, has developed a unique immuno-oncology approach to improve patient survival and quality of life by launching the patient's own immune system to fight cancer.
, the company announced that the U.S. Food and Drug Administration (FDA) has granted its lead candidate therapy, Ilyxadencel Orphan Drug (ODD), for the treatment of soft tissue sarcoma (STS).
this qualification recognizes the results of phase I/II clinical trials of gastrointestinal mesothelioma (GIST), a rare and difficult-to-treat tumor that falls into the STS category.
May 2020, the FDA granted Ilixadencel advanced regenerative medicine (RMAT) for the treatment of metastatic renal cell carcinoma (RCC).
December 2020, the FDA granted iixadencel fast-track eligibility (FTD) for GIST treatment and orphan drug eligibility (ODD) for treatment of hepatocellular carcinoma (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.
the preparation and mechanism of action of
lixadencel (click on the image to see the graph) Ilixadencel's active ingredient is degenerate cells (DCs) from healthy blood donors, which are specially activated to 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.
Dr. Sven Rohmann, chief executive of immunicum, said, "We continue to build recognition of the potential of iixadencel and are pleased to announce that, in addition to our qualifications in Renal Cell Carcinoma (RCC) and Hepatocellular Carcinoma (HCC), we have now received FDA-granted orphan drug eligibility for the treatment of soft tissue sarcoma, including GIST.
GIST is highly resistant to traditional radiotherapy and chemotherapy and, based on positive data from our Phase I/II clinical trials, provides additional motivation for the treatment of GIST and encourages us to apply iixadencel to patients as soon as possible.
": Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment of Soft Tissue Sarcoma (STS)