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INOVIO (NASDAQ: INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced today that data from the company's novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo® (cemiplimab) in the treatment of newly diagnosed glioblastoma (GBM), will be presented by Dr. David Reardon in the plenary session at the Society for Neuro-Oncology (SNO) 2020 Annual Meeting. The study demonstrated that INO-5401 + INO-9012 with Libtayo, radiation (RT) and temozolomide (TMZ) are tolerable, immunogenic, and may improve median survival for patients with newly diagnosed GBM. Survival data at 18 months showed that 70% (14/20) of MGMT promoter methylated GBM patients were alive, and 50% (16/32) of MGMT promoter unmethylated patients, which are the more difficult to treat group, were alive after 18 months. Median overall survival in the unmethylated GBM patients was 17.9 months, which compares favorably to historical controls; Median OS for methylated patients has not yet been reached and the study is ongoing.
Dr. David Reardon, Clinical Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and coordinating principal investigator of GBM-001 said, "This is a landmark combination trial in which a novel DNA vaccine is combined with a checkpoint inhibitor and radiation and chemotherapy. We look forward to continuing to review these data, with an eye towards those patients who are most likely to benefit from this innovative approach and to see whether, over time, there is an extension of survival in these very hard-to-treat patients. Coupling immune response with clinical outcome may prove insightful."
Interim data demonstrated that in the MGMT promoter unmethylated cohort, 19/22 (86%) subjects to date had an IFN-gamma T cell response that increased over baseline to one or more of the antigens encoded by INO-5401. In the MGMT promoter methylated cohort, 16/17 (94%) subjects to date had an IFN-gamma response that increased over baseline to one or more of the antigens encoded by INO-5401. The novel combination of INO-5401 + INO-9012 continues to demonstrate a well-tolerated safety profile when given not only with radiation and TMZ, but also with PD-1 blockade by Libtayo, which is being jointly developed by Regeneron and Sanofi.
Dr. Jeffrey Skolnik, INOVIO's senior vice president, clinical development, said, "INO-5401 + INO-9012, with Libtayo and RT/TMZ, generates cancer antigen-specific T cells that may be able to attack GBM and provide a survival advantage. We are using our knowledge of immunology to define a patient population for which this novel DNA medicine plus checkpoint inhibitor combination may offer a survival advantage, by continuing to assess all of our data: efficacy, safety and most important, immunogenicity and tissue expression data."
Additional data will be provided in the coming months, including correlative immunology and tissue data, as well as total study drug exposure and concomitant medication use.
INO-5401, INO-9012 and Libtayo, and the combination of these products have not been approved or evaluated by any Regulatory Authority worldwide for the treatment of newly diagnosed GBM.
Title: "INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma"
Presenting Author: Dr. David Reardon Plenary Session Date and Time: 2020 SNO Annual Meeting, Plenary 1A, Friday, November 20, 2020 beginning at 11 a.m. EST
The trial was designed to evaluate safety, immunogenicity and efficacy of INO-5401 and INO-9012 in combination with Libtayo, with radiation and chemotherapy, in subjects with newly diagnosed glioblastoma (GBM). This is a Phase 1/2, open-label, multi-center trial conducted in 52 evaluable patients with GBM. There are two cohorts in this trial. Cohort A includes 32 participants with a tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. Cohort B includes 20 participants with a tumor with a MGMT methylated promoter. Both cohorts received INO-5401 and INO-9012 and Libtayo at the same doses and on the same dosing schedule, and both cohorts received radiation and TMZ. For more information of the clinical study, see www.clinicaltrials.gov, identifier NCT03491683.