Apogenix, a next generation immuno-oncology company, has entered into an exclusive licensing agreement with CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, for the development and commercialisation of lead immuno-oncology drug candidate APG101 in China, Macao, and Hong Kong.
Under the terms of the agreement, Apogenix will receive upfront and milestone payments, as well as royalty payments at tiered, double-digit royalty rates following commercial launch of APG101 in China.
APG101 is a CD95 ligand inhibitor which restores the immune response against tumours and inhibits invasive tumour cell growth. The drug candidate is being developed for the treatment of solid tumours 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 commercialise our immuno-oncology compound APG101 as a new therapy for difficult-to-treat tumour 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 chief executive officer. "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," said Henri Termeer, CANbridge's advisor and former chairman and chief executive officer 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 programme forward more effectively than either could alone in China."