Date: 2017-05-08
Type of information: Clinical research agreement
Compound: REGN2810, INO-5401, INO-9012
Company: Inovio Pharmaceuticals (USA - PA) Regeneron Pharmaceuticals (USA - NY)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
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).
- • 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.
Disease: glioblastoma
Details:
- • On May 8, 2017, Inovio Pharmaceuticals and Regeneron Pharmaceuticals announced a clinical study agreement for a phase 1b/2a immuno-oncology trial. The study will be conducted by Inovio in patients with newly diagnosed glioblastoma multiforme (GBM) and will evaluate Regeneron’s PD-1 inhibitor, REGN2810, in combination with Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12.
- The open-label trial, which is expected to begin later this year, is designed to evaluate the safety and efficacy of the combination therapy in approximately 50 patients. The study will be conducted at 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.
- Under the terms of the agreement, the trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon study design, and Regeneron will supply REGN2810. Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, in collaboration with Sanofi, is developing REGN2810 both alone and in combination with other therapies for the treatment of various cancers.
Financial terms:
Latest news:
Is general: Yes
