Apogenix has been granted PRIME designation by the EMA to treat glioblastoma, the most common and aggressive form of malignant brain cancer.

Based in Heidelberg, Apogenix develops immuno-oncology therapeutics against solid tumors. Its lead candidate, asunercept (APG101), has now been awarded priority medicine (PRIME) designation from the European Medicines Agency based on the results of a Phase II trial, in which it showed a significant increase of survival and quality of life in 86 patients with relapsed glioblastoma.

The PRIME program, launched in March last year, is restricted to medicines that address a high unmet need. The EMA has only granted this designation to 23% of requests. In this case, asunercept addresses the lack of effective treatments for glioblastoma, which is linked to frequent relapse and a five-year survival rate under 35%.

apogenix ema priority asunercept APG101

Asunercept is a fully human fusion protein formed by the extracellular domain of the CD95 receptor and the Fc domain of an IgG1 antibody. It blocks the CD95 ligand present in tumoral cells, which has been shown to induce tumor growth and immune suppression. Apogenix is also working on a companion diagnostic test after finding in Phase II that patients presenting a biomarker associated with CD95 benefitted the most from the treatment.

With the EMA backing it, asunercept could soon be another immune checkpoint inhibitor in the market. Currently, practically all big pharma seem to have a checkpoint inhibitor against PD1 or PD-L1 in the pipeline or in the market. Apogenix will be introducing a new type by targeting CD95 instead, a molecule involved in bladder, ovarian, prostate, colon, pancreatic, kidney and breast cancer.

While partnered with AbbVie in other immuno-oncology programs, Apogenix still retains the worlwide rights to asunercept excepting China and Taiwan. Could this small German biotech take a bite out of big pharma’s monopoly over checkpoint inhibitors?


Images via Kjpargeter / Shutterstock; Apogenix

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