Cancer trial to watch for Glioblastoma

Shares of Immuno Cellular Therapeutics Ltd (NYSEMKT:IMUC), declined -17.15% to $0.430, during its last trading session.
Immuno Cellular Therapeutics, declared the presentation recently of recently updated overall survival (OS) results and immune response data from the phase 2 trial of ICT-107 in patients with newly diagnosed glioblastoma. ICT-107 is a dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. The data are being presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, being held in San Antonio, TX. The data from the phase 2 trial continue to indicate a survival advantage in the ICT-107 treated group contrast to the control group. The data also show a noteworthy association between immune response and survival, especially in HLA-A2 positive (HLA-A2+) patients, which is the target patient population for the phase 3 registration trial.

• In HLA-A2+ patients, immune response was shown to be associated with survival. 60% of ICT-107 treated patients demonstrated a statistically noteworthy immune response contrast to only 36% of control patients. In a KM comparison of OS for immune responders as compared to non-responders, the responder curve showed a statistically noteworthy survival benefit with a log-rank p-value of 0.0084. For ICT-107 treated patients, the KM comparison of OS for responders as compared to non-responders showed a statistically noteworthy survival benefit with a log-rank p-value of 0.0147. The Company believes that the relationship between immune response and OS supports the phase 3 design improvement of adding more ICT-107 doses for patients in the first year of the protocol.
• Immune response did not differ statistically for MGMT methylated contrast to unmethylated patients. This result supports counting both MGMT types of patients in phase 3 testing.
• Of particular interest was the unpredictable finding that there was an raised immune response in some control patients post-treatment. One potential explanation is that the phase 2 control (activated dendritic cells without peptide loading) was immunologically active. The phase 3 design employs a different control comprising the patients’ own monocytes, which are less immunologically active than dendritic cells. This control could assist clarify a potential survival difference between ICT-107 and control treated patients.