EMA Grants PRIME Designation to Apogenix Glioblastoma Drug

Apogenix AG, a biopharmaceutical company developing next-generation immuno-oncology therapeutics, announced that it has been awarded PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for its lead product candidate, asunercept (APG101), for the treatment of glioblastoma. The PRIME designation was based on the results of a Phase 2 trial (APG101_CD_002) of 86 adult patients with relapsed glioblastoma treated with asunercept. Data from this trial have been published in a peer-reviewed medical journal (Clin Cancer Res. 2014 Dec 15;20(24):6304-13).

In March 2016, the EMA launched the PRIME program to enhance support for the development of medicines that target an unmet medical need. Eligibility criteria are similar to those of the U.S. Food and Drug Administration (FDA) breakthrough therapy program. The goal of the PRIME program is to help patients to benefit as early as possible from therapies that may significantly improve their quality of life. The program focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. These medicines are considered priority medicines by EMA. To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data. Since the inception of the program in March 2016 only 23% (25 of108) of requests were granted for access to the program (www.ema.europa.eu/docs/en_GB). Through PRIME, the agency offers early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of marketing applications.

“There is a high unmet need for new medicines to treat glioblastoma patients, who have very few treatment options. The PRIME designation by the EMA supports our belief that asunercept has the potential to improve the lives of patients suffering from glioblastoma, a deadly form of brain cancer,” said Harald Fricke, M.D., Chief Medical Officer of Apogenix. “We are committed to working closely with the agency to make asunercept available to patients as expeditiously as possible.”