Apogenix Strengthens Patent Position for Lead Drug Candidate Asunercept
Heidelberg, Germany, August 1, 2018 - Apogenix, a biopharmaceutical company developing next generation immuno-oncology therapeutics, announced today that it was granted two key patents for lead immuno-oncology candidate asunercept in multiple territories.
A composition of matter patent protecting the product asunercept and its manufacturing process was already granted in 2016 by the U.S. Patent and Trademark Office. Apogenix has now received the corresponding composition of matter patents in Europe, Japan, Australia, and Russia. The patents are valid through 2033 in these territories.
The company was further granted a method of use patent covering the use of CD95 ligand inhibitors, such as asunercept, to treat patients with low to intermediate-1 risk myelodysplastic syndromes (MDS) in the United States, China, Japan, Australia, and Russia at least until 2033. The corresponding European patent was already granted in 2016. This is the second method of use patent that Apogenix has received for its lead drug candidate asunercept. The company already holds patents covering the medical use of CD95 ligand inhibitors for the treatment of glioblastoma in key territories such as Europe, the United States, Canada, and Japan. These patents are valid at least until 2027.
"Apogenix has a strong patent portfolio protecting its immuno-oncology projects in all leading pharmaceutical markets," said Thomas Hoeger, Ph.D., CEO of Apogenix. "These new patents expand the IP protection for asunercept even further and are critical in harnessing the medical and economic potential of this innovative drug candidate. We are currently preparing additional clinical trials with asunercept in both glioblastoma and MDS, so patients can benefit from this new therapeutic approach as soon as possible."
Apogenix' lead immuno-oncology candidate asunercept is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc domain of an IgG1 antibody. It is being developed for the treatment of solid tumors and malignant hematological diseases. Asunercept was granted orphan drug designation for the treatment of glioblastoma and myelodysplastic syndromes (MDS) in both the EU and the US. In 2017, asunercept received PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of glioblastoma.
Apogenix is a private company developing innovative immuno-oncology therapeutics for the treatment of cancer and other malignant diseases. The Heidelberg, Germany-based company has built a promising pipeline of immuno-oncology drug candidates that target different tumor necrosis factor (TNF) superfamily-dependent signaling pathways, thereby restoring the immune response against tumors. Checkpoint inhibitor asunercept, the company's lead immuno-oncology candidate, is in late-stage clinical development. Based on its proprietary technology platform for the construction of novel hexavalent TNF superfamily receptor agonists (HERA-ligands), Apogenix develops CD40, CD27, GITR, HVEM, 4-1BB, and OX40 receptor agonists for cancer immunotherapy.
In 2015, Apogenix entered into an exclusive licensing agreement with CANBridge Life Sciences for the development and commercialization of asunercept for the treatment of glioblastoma in China, Macao, Hong Kong, and Taiwan. CANbridge has received approval by the China Food and Drug Administration for a pivotal phase II/III trial with asunercept (CAN008) in glioblastoma in China. The HERA-TRAIL receptor agonist program was partnered with AbbVie in 2014. In 2017, AbbVie initiated a phase I trial with this HERA-TRAIL receptor agonist (ABBV-621) in patients suffering from solid tumors, non-Hodgkins's lymphoma, or acute myeloid leukemia.
Thomas Höger, Ph.D., CEO
Phone: +49 6221 58608-0
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