APG101 is a CD95 ligand inhibitor which restores the immune response against tumors and inhibits invasive tumor cell growth. The drug candidate is being developed for the treatment of solid tumors and malignant hematological diseases. In a controlled phase II proof-of-concept trial in patients with recurrent glioblastoma, treatment with APG101 in combination with radiotherapy has demonstrated clinical superiority in all study endpoints compared to treatment with radiotherapy alone.
"The licensing agreement with CANbridge represents an important milestone in our goal to develop and commercialize our immuno-oncology compound APG101 as a new therapy for difficult-to-treat tumor indications on an international level," said Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix. "We are delighted to have found a strong and committed partner with a seasoned management team and extensive drug development expertise in these important Asian markets. We look forward to working with CANbridge to obtain approval for APG101 in China, Macao, and Hong Kong, so we can provide patients suffering from glioblastoma with a novel, much-needed therapeutic option as soon as possible."
In the phase II trial, glioblastoma patients expressing a certain biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with APG101. The trial showed a statistically significant prolongation of overall survival in biomarker-positive patients treated with APG101, with a median overall survival of 16.1 months compared to 7.3 months in patients treated with radiotherapy alone. Apogenix is developing a companion diagnostic test based on this biomarker to identify those patients most likely to benefit from APG101.
"Development of this targeted therapeutic fits the CANbridge mission of bringing promising Western treatments to China and other Asian territories, where patients' severe medical needs are going unmet," said James Xue, CANbridge Chairman and CEO. "The mortality rate of malignant glioma is one of the top ten among all cancers in China. With very limited treatment options, the outcomes for Chinese patients are even more grim than in the West. The potential to develop a targeted immuno-oncology product represents a tremendous advance for glioblastoma treatment in China."
"The CANbridge and Apogenix missions and cultures are perfectly aligned, which bodes well for the success of this partnership," saidHenri Termeer, CANbridge's Advisor and former Chairman and CEO of Genzyme Corporation. "Each company is dedicated to bringing forth treatments in their respective markets for patients with few options. Together, CANbridge and Apogenix can move this exciting program forward more effectively than either could alone in China."
Apogenix is a next generation immuno-oncology company focusing on the development of innovative protein therapeutics for the treatment of cancer and other malignant diseases. With a dedicated, highly qualified team, we have built a promising pipeline of drug candidates that target tumor necrosis factor superfamily (TNFSF)-dependent signaling pathways. Apogenix' TNFSF modulators restore the immune response against tumors and inhibit invasive tumor cell growth. Since its inception in fall 2005, Apogenix has raised more than 50 million euros from its investors and was awarded public grants totaling 8.5 million euros. The company is based in Heidelberg, Germany.
Apogenix' 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, APG101 restores the immune response against tumors and inhibits invasive tumor cell growth.