Apogenix Strengthens Patent Position for Apocept™ (APG101) in Europe and Canada

HEIDELBERG, Germany, July 2, 2013 /PRNewswire/ -- Apogenix GmbH, a clinical stage biopharmaceutical company developing novel protein therapeutics for the treatment of cancer and inflammatory diseases, announced today that it was able to expand the patent protection for its lead product candidate Apocept™ (APG101). The company was recently granted two patents that cover the medical use of Apocept (APG101) in Europe and Canada. The European patent protects the medical use of CD95 inhibitors and CD95 ligand inhibitors, such as Apocept (APG101), for the treatment of glioblastoma. This patent is valid until 2027. The Canadian patent covers the use of CD95 ligand inhibitors for the treatment of neurological disorders and expires in 2024. Additional patent applications in the US and other key markets are pending.

"Apogenix has now a very extensive patent portfolio that provides broad coverage for the use of CD95 inhibitors and CD95 ligand inhibitors in the treatment of brain tumors. Expanding the patent protection is an important element in harnessing the medical and economic potential of this innovative therapeutic approach," Dr. Thomas Hoeger, CEO/CFO of Apogenix, stated. 

Apocept (APG101) is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc portion of an IgG antibody. The interaction between the CD95 ligand and the CD95 receptor activates an intracellular signaling pathway that stimulates the invasive growth and migration of tumor cells, such as glioblastoma cells. Apocept (APG101) binds to the CD95 ligand and thus inhibits activation of the CD95 signaling pathway, resulting in reduced tumor cell growth and migration. Similar effects have been observed in other solid tumors, such as liver, ovarian, and pancreatic cancer. This underlines Apocept's (APG101) therapeutic potential in other indications in which inhibition of the CD95 ligand plays an important role.

A controlled phase II proof of concept study with Apocept (APG101) in patients with recurrent glioblastoma multiforme (GBM) has met and exceeded its primary endpoint in March 2012. The primary endpoint was to double the number of patients reaching progression-free survival at six months (PFS6). A number of important secondary endpoints were also met in 2012. In January 2013, Apogenix initiated a clinical phase I trial with Apocept (APG101) to treat patients with myelodysplastic syndromes (MDS).

Apocept (APG101) is currently protected by nine patent families covering both the composition of matter as well as the use of the substance in various indications. In addition, Apocept (APG101) was granted orphan drug status in the EU for the treatment of glioma and in the US for the treatment of GBM and MDS.

About Apogenix
Apogenix, a spin-out of the German Cancer Research Center (DKFZ), develops novel protein therapeutics for the treatment of cancer and inflammatory diseases. The compounds' mechanism of action is either based on the targeted modulation of apoptosis, the programmed cell death, or on the inhibition of tumor cell growth. The company's lead product candidate Apocept™ (APG101) is being developed for the treatment of glioblastoma multiforme (GBM) and myelodysplastic syndromes (MDS). Since its inception in 2005, the company has raised more than €50 million in three financing rounds and was awarded public grants totaling €8.5 million. Apogenix is based in Heidelberg, Germany.

About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) belongs to the group of gliomas and is the most frequent and aggressive brain tumor. The tumor cells show a high resistance to radiation and chemotherapy. They spread and infiltrate the neighboring tissue so quickly that eradicative surgery is often impossible. Due to the diffuse infiltration into the brain tissue, recurrence is often experienced within a few months of the initial treatment. Approximately 28,000 new cases of malignant glioma are diagnosed every year in the US and the EU (source: US National Cancer Registry). The current standard therapy consists of surgery, followed by radiotherapy and chemotherapy. The relative survival rate for adults diagnosed with GBM is less than 30 percent within one year of diagnosis, and only three percent of patients live longer than five years after initial diagnosis (source: Central Brain Tumor Registry of the United States), illustrating a high unmet medical need in this indication.

About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are clonal hematopoietic stem cell disorders characterized by ineffective hematopoiesis leading to blood cytopenias, especially anemia. The median age for MDS is more than 60 years. The incidence rate for MDS is about 4/10,000 per year and increases to 20-50/10,000 above the age of 70. The disease is often diagnosed during a routine check-up. MDS patients generally suffer from a reduced red blood cell count (anemia), feel tired, and are prone to infections. In most cases, the anemia is treated with blood transfusions that eventually result in an iron overload, which can damage the liver, for instance. At the same time, the number of thrombocytes that are responsible for coagulation and the number of leucocytes that are responsible for immune defense are significantly decreasing. As a result, MDS patients frequently suffer from infections and sudden bleeding, which can prove fatal. For more information about MDS, please visit www.mds-foundation.org.

SOURCE Apogenix