ImmunoCellular Therapeutics has suspended further patient randomization in its Phase 3 trial for its ICT-107, after determining that it cannot secure enough funding to complete the trial (NCT02546102).
The study was to evaluate ICT-107 — a patient-specific, dendritic cell-based immunotherapy for people with newly diagnosed glioblastoma — in subjects randomized to receive standard of care chemoradiation with Temodar (temozolomide) plus ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T-cells to specifically target glioblastoma tumor cells.
ICT-107 is made of dendritic cells prepared from a patient’s own mononuclear cells, pulsed with six synthetic peptides, or portions of a protein, derived from tumor associated antigens (TAA) present on glioblastoma tumor cells.
ICT-107 had previously completed Phase 2 testing (NCT01280552) with the first results presented in 2013, the company said on its website. The Phase 2 trial was designed as a double-blind, placebo-controlled, multicenter evaluation of ICT-107’s safety and efficacy in patients with newly diagnosed glioblastoma. From January 2011 until September 2012, the trial enrolled 278 patients at 25 centers nationwide, and patients were randomized to standard of care treatment plus ICT-107 or standard of care plus placebo.
In August 2015, ImmunoCellular announced an agreement regarding a special protocol assignment (SPA) with the U.S. Food and Drug Administration (FDA) for the Phase 3 trial evaluating ICT-107 in patients with glioblastoma.
The registrational trial was to measure overall survival as its primary endpoint and progression-free survival and safety as its secondary endpoints. The first patient was treated in June 2016. ImmunoCellular was anticipating randomization of all patients by the first half of 2019, plus an additional two or three years from then to achieve the number of required events to complete the trial.
ICT-107 received U.S. orphan drug designation in August 2015.
According to the press release, ImmunoCellular — headquartered in Calabasas, California — plans to work with current partners to ensure that patients already randomized and receiving treatment in the Phase 3 trial are appropriately supported and followed. The trial’s suspension is expected to reduce the company’s costs.
ImmunoCellular is currently looking for potential mergers or other business combinations to maintain its immuno-oncology R&D pipeline and technology platform.
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