Agreements

Date: 2017-03-23

Type of information: Clinical research agreement

Compound: ICT-107, ICT-140 and ISF35

Company: ImmunoCellular Therapeutics (USA - CA) Memgen (USA - TX

Therapeutic area: Cancer - Oncology

Type agreement: clinical research

Action mechanism: immunotherapy product/cell therapy

• ICT-107 is a dendritic cell-based immunotherapy targeting six tumor-associated antigens on glioblastoma stem cells. It is currently being tested in a phase 3 registration trial in patients with newly diagnosed glioblastoma. The ongoing phase 3 registrational trial of ICT-107 is designed as a randomized, double-blind, placebo-controlled study of HLA-A2+ subjects, which is being conducted at about 120 sites in the US, Canada and the EU, with plans to randomize 542 patients with newly diagnosed glioblastoma.
• ICT-140 is a dendritic cell-based immunotherapy targeting seven tumor-associated antigens expressed on ovarian cancer cells. ImmunoCellular plans to conduct a phase 2 clinical trial in patients with ovarian cancer, pending available resources.
• ISF35 is a viral cancer immunotherapy encoding an optimized form of CD40 ligand. Direct intratumoral delivery of ISF35, a non-replicating adenovirus encoding CD40 ligand, activates tumor-specific T cells through immunostimulation of dendritic cells. ISF35 generates an effective anti-tumor immune response and complements checkpoint inhibitors. Preclinical studies have shown that ISF35 in combination with checkpoint inhibitors cures 40% of mice with an aggressive B16 melanoma tumor, and eradicates melanoma brain metastases. These data add to the extensive clinical experience of ISF35 in chronic lymphocytic leukemia where safety and activity have been demonstrated. Preclinical research evaluating ISF35 in combination with PD-1, PD-L1, and CTLA-4 checkpoint inhibitors is guiding the clinical development of ISF35

Disease:

Details: * On March 23, 2017, ImmunoCellular Therapeutics and Memgen announce the signing of a non-binding letter of intent to exclusively negotiate the terms to possibly establish an immuno-oncology strategic collaboration focused on conducting clinical trials combining the companies' respective cancer immunotherapy product candidates. The discussions pertain to ImmunoCellular's dendritic cell (DC)-based immunotherapy product candidates, ICT-107 and ICT-140, and Memgen's ISF35, a viral cancer immunotherapy encoding an optimized version of CD40 ligand. Combining DC-based and viral oncology immunotherapeutic approaches could provide a novel way to stimulate CD40 to possibly induce a potent, specific and effective anti-tumor response. Insights from these combination trials, if successful, could also lead to later combination trials with other immune-oncology technologies, including checkpoint inhibitors. Preclinical research presented at the 2016 American Association of Cancer Research (AACR) Annual Meeting showed that ISF35 in combination with checkpoint inhibitors induces anti-tumor immune responses, expands tumor specific CD8 T cells, and has the potential to eradicate brain tumors. The combination of ISF35 and ICT-107 with checkpoint inhibitors may provide a multi-pronged antitumor immune response. This includes ISF35's CD40-driven dendritic and T cell activation and expansion, ICT-107's tumor-specific antigen presentation, and checkpoint inhibitor release of the PD-1 pathway-mediated inhibition of the antitumor immune response. If the parties agree upon the terms of a strategic collaboration, including financials, development, supply and control, ImmunoCellular and Memgen plan to work together to determine the best clinical strategy to leverage the collaboration.  

Financial terms:

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