Date: 2017-11-01
Type of
information: Initiation of the trial
phase: 1b/2a
Announcement: initiation of the trial
Company: Inovio Pharmaceuticals (USA - PA)
Product: REGN2810 (cemiplimab) and INO-5401
Action
mechanism:
- immunotherapy product/monoclonal antibody/immune checkpoint inhibitor/DNA vaccine/plasmid
- • REGN2810 is a fully human monoclonal antibody to Programmed Death-1 (PD-1) developed by Regeneron Pharmaceuticals.
- • INO-5401 includes Inovio’s SynCon® antigens for WT1, hTERT and PSMA and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development. WT1 was at the top of the list. The hTERT antigen relates to 85 percent of cancers, and WT1 and PSMA antigens are also widely prevalent in many cancers.
- INO-9012 is a plasmid DNA vaccine encoding interleukin-12 (IL-12). Upon intramuscular delivery by electroporation of DNA plasmid encoding interleukin-12 INO-9012, IL-12 is translated in cells and activates the immune system by promoting the activation of natural killer cells (NK cells), inducing secretion of interferon-gamma and promoting cytotoxic T-cell responses against tumor cells. This may result in both immune-mediated tumor cell death and the inhibition of tumor cell proliferation.
- • In May 2017, Inovio Pharmaceuticals and Regeneron Pharmaceuticals have concluded a clinical study agreement for a phase 1b/2a immuno-oncology trial. The study will evaluate the three products in patients with newly diagnosed glioblastoma. The combination trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon trial design, and Regeneron will supply cemiplimab. Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, as part of their immuno-oncology collaboration with Sanofi, is developing cemiplimab both as a monotherapy and in combination with other therapies for the treatment of various cancers.
Disease: glioblastoma
Therapeutic
area: Cancer - Oncology - Rare diseases
Country: USA
Trial
details:
Latest
news:
- • On November 1, 2017, Inovio Pharmaceuticals initiated a phase 1b/2a immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) designed to evaluate cemiplimab (REGN2810), in combination with INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12.
- The open-label trial of 50 patients will be conducted at approximately 30 U.S. sites, and the primary endpoints are safety and tolerability. The study will also evaluate immunological impact, progression-free survival and overall survival.
Is
general: Yes
