On July 19, 2016 Apogenix, a biopharmaceutical company developing next-generation immuno-oncology therapeutics, reported that the European Patent Office has granted the Company a patent for the use of CD95 ligand inhibitors including APG101 in the treatment of myelodysplastic syndromes (MDS) (Press release, Apogenix, JUL 16, 2016, View Source [SID1234524578]). The patent covers the use of such inhibitors in low to intermediate-1 risk transfusion-dependent MDS patients and is valid until July 2033.
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While Apogenix already holds a broad patent portfolio covering APG101, including composition of matter as well as manufacturing and method of treatment of glioblastoma, this is the first patent to cover its clinical use specifically in MDS patients.
"The granting of this additional patent for APG101 further validates our innovative drug development approach and strengthens the protection of our most advanced asset," said Thomas Hoeger, Ph.D., CEO of Apogenix. "With the recently announced positive results from the Phase I trial in MDS patients, we now intend to further develop APG101 in this indication, for which today there are no sufficient treatment options available.
The recently completed Phase I trial evaluated APG101 in low to intermediate-1 risk transfusion-dependent MDS patients and demonstrated the tolerability as well as activity of the drug candidate: APG101 treatment stimulated erythropoiesis and led to a significant decrease in transfusion frequency in this patient population. To further evaluate the efficacy and safety of APG101 in the treatment of MDS patients, Apogenix is currently in preparation of Phase II proof-of-concept trials.
About Myelodysplastic Syndromes (MDS) MDS is a bone marrow disorder that is characterized by ineffective hematopoiesis and can lead to severe anemia. In most cases, the anemia is treated with blood transfusions that eventually result in an iron overload, which can damage the liver and other organs. At the same time, the number of thrombocytesthat are responsible for coagulation and the number of leucocytes that are responsible for immune defense significantly decrease in patients with this disorder. As a result, MDS patients frequently suffer from sudden bleeding and lifethreatening infections. In addition, they are at risk of developing acute myeloid leukemia, a type of blood cancer. About APG101 Apogenix’s lead immuno-oncology candidate APG101 is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc domain of an IgG antibody. APG101 is being developed for the treatment of solid tumors and malignant hematological diseases. By blocking the CD95 ligand, which negatively regulates erythrocyte production in MDS patients, APG101 directly addresses the cause of the disorder and could thus potentially provide a cure for MDS.