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Apogenix Granted PRIME designation by European Medicines Agency for Asunercept to Treat Glioblastoma

DGAP-News: Apogenix AG / Key word(s): Miscellaneous Apogenix Granted PRIME designation by European Medicines Agency for Asunercept to Treat Glioblastoma 29.05.2017 / 11:00 The issuer is solely responsible for the content of this announcement. Press Release

Apogenix Granted PRIME designation by European Medicines Agency for Asunercept to Treat Glioblastoma

PRIME program designed to help patients benefit as early as possible from therapies that may significantly improve their quality of life

Heidelberg, Germany, May 29, 2017 - Apogenix AG, a biopharmaceutical company developing next-generation immuno-oncology therapeutics, announced today 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.