Date: 2016-01-07
Type of information: Milestone
Compound: APG101
Company: Apogenix (Germany) CANbridge Life Sciences (China)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: fusion protein. APG101 is a first-in-class, fully human fusion protein combining the extracellular domain of the CD95 receptor and the Fc portion of IgG. 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. APG101 binds to the CD95 ligand and thus inhibits activation of the CD95 signaling pathway, resulting in reduced tumor cell growth and migration. APG101 was granted orphan drug status for the treatment of glioma (EU/3/09/709) in the EU and for the treatment of glioblastoma and myelodysplastic syndromes in the US.
Disease: solid tumors and malignant hematological diseases
Details: * On July 15, 2015, Apogenix announced that it 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 commercialization of lead immuno-oncology drug candidate APG101 in China, Macao, and Hong Kong.
APG101 is a CD95 ligand inhibitor that is being developed for the treatment of solid tumors and malignant hematological diseases. 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.
Financial terms: 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.
Latest news: * On January 7, 2016, Apogenix announced that the first milestone of its licensing agreement with CANbridge Life Sciences for the development and commercialization of lead immuno-oncology candidate APG101 in China, Macao, and Hong Kong has been reached, triggering a milestone payment. In addition, Apogenix and CANbridge have signed an amendment to expand the licensed territories to include Taiwan. Apogenix will continue to develop APG101 in all other territories.
An initial biomarker study conducted by CANbridge in Chinese glioblastoma patients revealed a high degree of CD95 ligand expression and confirmed the expression pattern seen in Apogenix’ phase II proof of concept trial in patients with recurrent glioblastoma. Apogenix looks forward to CANbridge initiating a phase I/II trial with APG101 in newly-diagnosed glioblastoma patients in Taiwan in the second half of this year.
