BioSenic offers a unique treatment value by developing two innovative product lines: an arsenic trioxide-based treatment for autoimmune diseases and cell therapy products.
Our goal is to provide a curative treatment for often fatal diseases and to significantly improve the comfort of life of patients in rare diseases.
The ATO we use is effective in autoimmune indications. Our product is part of a first-line therapy for unmet medical needs for which no effective treatment exists.
Arsenic trioxide has the unique property of increasing cellular oxidative stress to the point where it induces cell death of activated cells (enhanced apoptosis).
In other words, it has a specific, long-term immunosuppressive effect on activated cells, without affecting the normal components of the immune system and with perfectly controlled side effects. It probably acts at a very fundamental level and upstream of the immune cascade, because in animal models we observe a correction of all the parameters signalling the autoimmune cascade.
Arsenic trioxide GMP obtained by de novo synthesis from the basic chemical elements has been included in a formulation that can be administered orally.
This formulation is original and protected by international patents and an exclusive license and extended marketing rights for in particular the indication Chronic Graft versus Host Disease, which is BioSenic's main pathological target. The particular advantage of this formulation is its oral use, a major benefit for clinicians and patients.
This formulation has the characteristics of rapid gastrointestinal solubilization, optimal bioavailability comparable to the intravenous formulation, and bioequivalence that has recently been proven in a very rare condition, acute promyelocytic leukemia.
Our aim is to improve:
BioSenic has developed a first-in-class products, ALLOB. The manufacturing process consists of the ex vivo culture of human bone marrow cells in order to generate human osteoblastic cells. All of BioSenic's products are manufactured to the highest GMP standards and all trials are designed in close consultation with the regulatory authorities. ALLOB is classified as advanced therapy medicinal products in Europe, renowned to have some of the strictest guidelines for the development of cell therapy products.
BioSenic's robust patent portfolio combined with its solid expertise in the field gives BioSenic a unique position to exploit its proprietary technology platform.
Through its subsidiary Medsenic, BioSenic also has an exclusive license to exploit arsenic trioxide in the treatment of autoimmune diseases thanks to the CNRS. In addition, the EMA (European Medicine Agency) and the FDA (US Food and Drug Administration) have granted ODD (Orphan Drug Designation) status to the use of arsenic trioxide for the treatment of cGvHD. This recognition allows BioSenic to benefit from an industrial and commercial protection extended by 7 years in the USA and 10 years in Europe compared to the initial duration of its patents.
Today BioSenic intends to become a leader in the medical arsenic market with the acquisition of patents in development and by patenting its own research in the field of inflammation and autoimmunity.
BioSenic's cellular products are manufactured under the highest GMP standards and are protected by a strong Intellectual Property portfolio, covering 9 patent families.
ALLOB ® has received orphan drug designation* for hip osteonecrosis in the European Union and the United States.
EMAM (Europe) and the FDA (United States) have also granted ALLOB orphan drug designation for osteogenesis imperfecta (glass bone disease).
BioSenic has registered the ALLOB trademark in the Benelux, the European Union, the United States, Japan and South Korea.
*Orphan drug designation grants special status to a drug developed to treat rare diseases or disorders. By obtaining orphan drug designation, the Company benefits from incentives, including regulatory assistance and market exclusivity when the drug is approved for marketing.