First clinical results of a personalized immunotherapeutic vaccine against recurrent, incompletely resected, treatment-resistant glioblastoma multiforme (GBM) tumors, based on combined all- and auto-immune tumor reactivity

Glioblastoma multiforme (GBM) patients have a poor prognosis. After tumor recurrence statistics suggestan imminent death within 1–4.5 months. Supportive preclinical data, from a rat model, provided therational for a prototype clinical vaccine preparation, named Gliovac (or ERC 1671) composed of autologousantigens, derived from the patient’s surgically removed tumor tissue, which is administered together withallogeneic antigens from glioma tissue resected from other GBM patients. We now report the first resultsof the Gliovac treatment for treatment-resistant GBM patients.Nine (9) recurrent GBM patients, after standard of care treatment, including surgery radio- andchemotherapy temozolomide, and for US patients, also bevacizumab (AvastinTM), were treated under acompassionate use/hospital exemption protocol. Gliovac was given intradermally, together with humanGM-CSF (Leukine®), and preceded by a regimen of regulatory T cell-depleting, low-dose cyclophos-phamide.Gliovac administration in patients that have failed standard of care therapies showed minimal toxicityand enhanced overall survival (OS). Six-month (26 weeks) survival for the nine Gliovac patients was 100%versus 33% in control group. At week 40, the published overall survival was 10% if recurrent, reoperatedpatients were not treated. In the Gliovac treated group, the survival at 40 weeks was 77%. Our datasuggest that Gliovac has low toxicity and a promising efficacy. A phase II trial has recently been initiatedin recurrent, bevacizumab naïve GBM patients (NCT01903330)