11/4/2016 3:47:18 PM
First Asian Clinical Trial with Asunercept (APG101) Initiated in Glioblastoma Patients
Heidelberg, Germany, November 4, 2016 - Apogenix, a biopharmaceutical company developing next-generation immuno-oncology therapeutics, today announced the achievement of additional milestones under its licensing agreement with CANbridge Life Sciences for the development and commercialization of lead candidate APG101 (INN: asunercept) in China, Macao, Hong Kong and Taiwan, triggering further payments to Apogenix. The milestones are related to the successful implementation of the technology transfer necessary for the production of this CD95 ligand inhibitor at the Chinese production site.
Over the course of the past few months, Apogenix and CANbridge have successfully transferred the necessary cell banks, assays, protocols, and know-how for the manufacturing of asunercept to China. The manufacturing process has proven to be very robust with product quality and process yields of the active substance comparable to the manufacturing process developed by Apogenix.
CANbridge also reported that clinical development of asunercept is now underway in Taiwan. The recently initiated Phase I/II trial is evaluating asunercept plus temozolomide (TMZ) during and after radiation therapy in 55 patients with newly diagnosed glioblastoma. The study design consists of an open-label, dose-escalation Phase I trial, and a multi-center, double-blind, randomized, placebo-controlled Phase II trial. The Phase I trial will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. The Phase II part will evaluate efficacy and safety.
"We are very pleased with the progress of our collaboration with CANbridge and the achievement of additional milestones," said Thomas Hoeger, Ph.D., CEO of Apogenix. "With the successful technology transfer and the initiation of the Phase I/II trial in Taiwan, the clinical development of asunercept in Asia is now well underway. We look forward to CANbridge initiating further trials in China soon."
James Xue Ph.D., Chairman and CEO of CANbridge: "The complex transfer of asunercept production technology and know-how has been very efficient due to the excellent collaboration between the CANbridge and Apogenix teams. In particular, we were impressed by the exceptional level of enthusiasm and professional handling during the entire process."
About Asunercept (APG101)
Apogenix's 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 IgG antibody. Asunercept is being developed for the treatment of solid tumors and malignant hematological diseases. The World Health Organization (WHO) has recently assigned the international nonproprietary name (INN) "asunercept" for APG101.
Apogenix is a private company developing innovative immuno-oncology therapeutics for the treatment of cancer and other malignant diseases. The company has built a promising pipeline of immuno-oncology drug candidates that target different tumor necrosis factor superfamily (TNFSF)-dependent signaling pathways, thereby restoring the immune response against tumors. Since its inception in 2005, Apogenix has raised more than 90 million euros in financing rounds, public grants, as well as upfront and milestone payments from licensing agreements. The company is based in Heidelberg, Germany.
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