ImmunoCellular Therapeutics, Ltd., announced it has come to an agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assignment (SPA) for the Phase III registrational study of its investigational immunotherapy, ICT-107, indicated for patients with glioblastoma.
ICT-107 is a dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. The trial will be randomized, double-blind, placebo-controlled, and will aim to enroll around 400 HLA-A2 positive patients. The study will be conducted across 120 sites in the US, Canada, and the European Union. The trial’s primary endpoint will be subjects’ overall survival, while its secondary endpoints will include progression-free survival and safety, and overall survival in two selected MGMT subgroups. The company expects to open enrolment towards the end of Q3 or the start of Q4 2015.
The FDA’s Special Protocol Assessment specifies what the agency and the sponsor company have agreed upon concerning a study’s design, endpoints, size, and statistical design. This study will serve as a basis for the company’s future efficacy claim when sending in a marketing application, such as a biologic licensing application (BLA) or a new drug application (NDA). A successful Phase III clinical trial will determine the FDA’s decision on granting final marketing approval.
Andrew Gengos, ImmunoCellular’s Chief Executive Officer commented: “We are pleased to have achieved this important milestone, and think that successful completion of the SPA process adds meaningful validation to the ICT-107 phase 3 program and design, especially the use of the gold standard primary endpoint of overall survival. With this SPA in place, we think that ICT-107 is uniquely positioned in the field of immuno-oncology approaches being tested in glioblastoma. We are making significant progress toward establishing our clinical site network and obtaining the necessary institutional review board approvals. We are confident that we are on track to begin patient enrollment in the late third quarter or early fourth quarter of this year.”
The University of Texas MD Anderson Cancer Center, together with Merck, will be evaluating the latter’s anti-PD-1 treatment, Keytruda (pembrolizumab), when administered in combination with other anti-cancer therapies, such as chemotherapy, radiation, and/or today’s newer anti-tumor drugs.
According to the terms of this strategic collaboration, MD Anderson and Merck will be conducting studies on the following types of tumors over a span of 3 years: gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, and hepatocellular carcinoma. The first series of research initiatives are set to open participant enrolment towards the latter part of 2015.