Regeneron and Inovio have signed up to a new combo trial deal that will see the pair add PD-1 inhibitor REGN2810 to Inovio’s immune activator and T-cell activator drugs in patients with newly-diagnosed glioblastoma multiforme (GBM), a hard-to-treat type of brain cancer.
The phase 1b/2a open-label trial, which should begin this year, will have 50 patients and focus on overall survival, as well as progression-free survival and immunological impact. This aggressive cancer has few treatments options and can hit younger patients, making any med that can show strong efficacy a much-needed advance.
The study will combine Regeneron’s PD-1 inhibitor REGN2810 (which is also being studied in other cancers with long-term partner Sanofi) and Inovio's T-cell activator INO-5401 as well as its immune activator INO-9012 in brain cancer.
The test, across 30 sites in the U.S., will combine Regeneron’s PD-1 inhibitor, REGN2810, with Inovio’s INO-5401 T-cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12.
Under the pact, the trial will be conducted and funded solely by Inovio, based upon a mutually agreed upon study design, while Regeneron will supply REGN2810.
Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Financial terms were not disclosed.
“Regeneron’s approach to oncology includes evaluating the combination of innovative therapies that act on diverse pathways and targets,” said Israel Lowy, M.D., Ph.D, VP of translation sciences and oncology at Regeneron.
“Using our PD-1 inhibitor as a therapeutic backbone alongside Inovio’s T cell-generating therapies offers a new path for exploration and heightens the potential to develop new, desperately-needed treatment options for patients.”
“I am a strong believer in this combination regimen approach in immuno-oncology: use Inovio immunotherapies to generate killer T-cells to turn 'cold' tumors into 'hot' tumors, then block T cell suppression via checkpoint inhibition," added J. Joseph Kim, Ph.D, Inovio's president and CEO. “This step with INO-5401 is very important for us in 2017, as we believe INO-5401 has the potential to be a powerful cancer immunotherapeutic in combination with promising checkpoint inhibitors such as Regeneron's REGN2810, and we look forward to investigating its potential for GBM and multiple other challenging cancers.”
Inovio, which has a market cap of just over $470 million, was up 2.6% this morning on the news.