Roughly 50 newly diagnosed GBM patients will participate in the open-label trial. The study began on May 31, 2018 is projected to complete on January 18, 2021.
Inovio Pharmaceuticals’ (NASDAQ:INO) first patient has officially been dosed in its Phase 1/2 immuno-oncology trial for patients newly diagnosed with glioblastoma (GBM), the company announced on Thursday (June 21).
The release states the purpose of the efficacy trial is to evaluate the company’s INO-5401 T cellactivating immunotherapy encoding multiple antigens expressed by GBM and INO-9012, an immune activator encoding IL-12, in combination with Regeneron Pharmaceuticals’ (NASDAQ:REGN) cemiplimab (REGN2810) PD-1 inhibator.
Roughly 50 newly diagnosed GBM patients will partake in the open-label trial with the primary endpoint being safety and tolerability, and will be conducted in at least 25 US states. The study will also look at immunological impact, progression-free survival and general survival.
“This is an important step for Inovio’s plan to use its T cell-generating therapies in combination with PD-1/PD-L1 inhibitors for GBM and for multiple other cancers to improve overall efficacy,” Dr. J. Joseph Kim, president and CEO of Inovio said in the release.
Kim added the goal the company has for this trial is to increase the survival rates of patients with GBM.
“In preclinical studies, combination of Inovio’s T cell-generating immunotherapies along with checkpoint inhibitors have shown to shrink tumors and improve overall survival of tumor-bearing animals,” he said.
Dr. David Reardon, the trial’s coordinating principal investigator and associate professor of medicine at Harvard Medical School and clinical director of the center for neuro-oncology, medical oncology at the Dana-Farber Cancer Institute, said the vaccine platform is “highly innovative” and has the potential to generate robust anti-tumor immune responses.
“We are very hopeful that this novel vaccine technology will translate into meaningful therapeutic benefit when integrated with standard radiation and temozolomide chemotherapy combined with anti-PD-1 treatment for newly diagnosed glioblastoma patients in our recently initiated trial,” he added.
According to ClinicalTrials.gov, two cohorts will be in this trial. The first–Cohort A–includes those with a tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. The second, Cohort, B will be participants with a tumor with a MGMT methylated promoter or who have indeterminate MGMT status.
Both will receive INO-5401 and INO-9012 and cemiplimab at the same time in the same doses and will receive radiation and temozolomide if clinically indicated.
Participants 18 years and older are eligible for the study, which began on May 31, 2018 and is expected to complete on January 18, 2021.
Inovio also holds clinical partnerships with MedImmune for INO-3112 (MEDI0457) in HPV-related cancers and collaborations with Roche/Genentech and Regeneron for INO-5401 in bladder cancer and GBM.
The company currently has a “Moderate Buy” rating according to TipRanks with an analyst price target of US$10.50, a high of US$13 and a low of US$8. The most recent analyst rating was reiterated on Thursday by analyst Jason McCarthy from Maxim Group with a “Buy” ranking and price target of US$8.
Following the announcement, shares of the company reacted with a 3.91 percent dip to US$4.18 from its previous close of US$4.35.
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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.