Apogenix Wins $3.3M Grant toward Trial of Lead Product, CDx Validation

February 16, 2016

Apogenix said today it has received approval for a €3 million ($3.3 million) grant from the German Federal Ministry of Education and Research toward further development of the company’s lead immuno-oncology candidate, APG101, for glioblastoma.

The grant will be used over three years for the CancerMark project, initiated this month. CancerMark is designed to confirm the efficacy of APG101 in an additional clinical trial and validate a companion diagnostic test to analyze the biomarker associated with the CD95 ligand.

"The CancerMark grant represents an important contribution to the development of our lead immuno-oncology candidate APG101 as a personalized therapy,” Apogenix CEO Thomas Hoeger, Ph.D., said in a statement. “The upcoming clinical trial to confirm the companion diagnostic test is an important milestone toward approval of APG101 for the treatment of glioblastoma, so patients can benefit from a personalized treatment approach.”

In July, Apogenix and R-Biopharm agreed to co-develop companion diagnostic tests for APG101 through a collaboration whose value was not disclosed.

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 designed to restore the immune response against tumors and inhibits invasive tumor cell growth by blocking the CD95 ligand, and is being developed for the treatment of solid tumors and malignant hematological diseases.

According to Apogenix, the efficacy of APG101 has been shown in a Phase II proof-of-concept trial in patients with recurrent glioblastoma. Glioblastoma patients expressing a biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with APG101.

The median overall survival rate in biomarker-positive patients treated with APG101 during the proof-of-concept trial more than doubled to 16 months compared to patients treated with radiotherapy alone, Apogenix said.

Dr. Hoeger said the CancerMark grant brings to €11 million ($12.3 million) in public grants the amount Apogenix has raised toward development of protein therapeutics for cancer and other diseases. That sum is part of the €90 million ($100.3 million) raised by Apogenix since its founding in 2005—a sum that also includes financing and licensing payments.