dm+d

Unassigned

New Medicines

Glioblastoma - first-line

Information

Vaccine
ImmunoCellular Therapeutics
ImmunoCellular Therapeutics

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Yes
Yes
Sep 21Development appears to have been discontinued [12].
Aug 19With the successful completion of the asset sale, ImmunoCellular plans to continue to pursue additional strategic alternatives, including a potential reverse merger with a private company seeking an expedited route to the public markets [10, 11].
Jul 19ImmunoCellular Therapeutics announces agreement with private biotechnology company for the purchase of substantially all of ImmunoCellular´s remaining clinical and pre-clinical assets, including its preclinical and clinical programs, technology, intellectual property and know-how(including ICT-107) [10, 11].
Jun 17ImmunoCellular Therapeutics suspends a PIII trial, after failing to raise the funds it needs to complete the study. They will now look for a commercial partner for the program, or an outright sale, and will consider restructuring the business if a partner or acquirer for ICT-107 is not identified in the near term. They intend to refocus and reallocate available resources on our stem-to-T-cell research programs [9].
Jan 17ImmunoCellular Therapeutics plans to seek a partner for PIII development and commercialisation of ICT 107 [7].
Aug 15Has orphan drug status in EU & US [1].

Category

An autologous dendritic cell-based vaccine. Dendritic cells are harvested from the patient, then cultured with specific antigens to produce more dendritic cells. The newly cultured dendritic cells are injected back into the patient.
Annual incidence of malignant brain tumours is 8.5 per 100,000 population, equating to approximately 3,500 cases each year in the UK. High grade gliomas represent 50-60% of all primary brain tumours, occurring at an approximate incidence rate of 3-4 per 100,000 population per year in England and Wales, of which glioblastoma multiforme (GBM) comprises 40-45% [3].
Glioblastoma - first-line
Intradermal

Trial or other data

Aug 18PIII (NCT02546102) study suspended as company is unable to secure sufficient financial resources to complete [13].
Dec 16PIII (NCT02546102) study is expected to complete collection of primary outcome data in Dec 19 [8].
Nov 16ImmunoCellular Therapeutics announces that about 225 patients have been screened, 11 have been randomised and clinical site activation is continuing in the registrational PIII study. The primary endpoint is overall survival, whereas progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups, will be assessed as secondary endpoints. Approximately 414 HLA-A2 positive patients will be enrolled in the study [7].
May 16Regulatory approvals granted to expand the registrational PIII study to Canada, the Netherlands, Spain and the UK; approvals eight other European countries are expected in Q3 2016, which will be followed by patient screening [7].
Nov 15ImmunoCellular Therapeutics initiates a registrational, double-blind PIII trial in newly diagnosed patients with glioblastoma to evaluate safety and efficacy of ICT 107 following resection and concurrent chemoradiotherapy with temozolomide (ICT-107-301; NCT02546102) [7].
Nov 15ImmunoCellular Therapeutics Ltd. announced updated overall survival (OS) results and immune response data from the PII trial of ICT-107 in patients with newly diagnosed glioblastoma. OS results were analyzed at three years after the last patient enrolled. For the 124-patient intent-to-treat population (ITT), median OS was 1.6 months or 10% better for ICT-107 patients than control. The difference in the Kaplan-Meier (KM) survival curves for this patient population was not statistically significant. OS results for the pre-specified subgroup of HLA-A2+ patients continue to support selecting this patient population alone for a well powered PIII trial; for the MGMT methylated, HLA-A2+ PP population, median OS was 13.8 months or 58% better for ICT-107 treated patients than control and for the MGMT unmethylated, HLA-A2+ per-protocol (PP) population, median OS was 4.0 months or 34% better for ICT-107 treated patients than control. The differences in the KM survival curves for the sub-populations were not powered for, and did not achieve, statistical significance. [16]
Aug 15ImmunoCellular Therapeutics announced an agreement with the FDA on a Special Protocol Assessment (SPA) for the PIII randomised, double-blind, placebo-controlled registrational trial of ICT-107. Approximately 400 HLA-A2 positive pts with newly diagnosed glioblastoma will be enrolled at about 120 sites in the US, Canada and the EU. The primary endpoint is overall survival. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups. Pt enrolment is anticipated to begin in the late third quarter or early fourth quarter of 2015 [5].
Nov 14Results of a PIIb randomised, double-blind placebo-controlled trial of ICT-107 in 124 pts with newly diagnosed glioblastoma (ICT-107-201; NCT01280552) were first released in December 2013. Pts received standard treatment, comprising surgery followed by radiotherapy and chemotherapy, and were randomised to receive either ICT-107 or placebo in the post-radiotherapy phase. The initial results showed that the trial failed to meet its primary endpoint of overall survival (OS). However, additional efficacy and safety results released Nov 14 demonstrated a numeric OS benefit; and a statistically significant benefit of 15.6 months in median progression-free survival (PFS) in the per protocol population of pts treated with ICT-107 compared to placebo (24.1 vs 8.5 months; p = 0.004). The ICT-107 treatment effect continued to be strongest in the pre-defined HLA-A2 subgroup of pts and MGMT (O m(6)-methylguanine-DNA methyltransferase) methylated pts showed the largest treatment effect. There were no differences in adverse events between the ICT-107 treated group and the control group [1,4].