Malignant Gliomas account for 80% of primary malignant brain tumors, including its most common and aggressive form, glioblastoma multiforme, and are associated with very poor prognosis. Five-year survival rates vary depending on age, from 5% (older patients) to 19% (younger patients), with death typically resulting in about 15 months. Over 15,000 patients a year in the United State die from the disease. The last drug product approved to treat the disease was temozolomide, approved nearly 20 years ago, with a meager 2.4 month survival benefit and significant side effects. Accordingly, there remains a significant need for effective drug products to treat this disease.
BrTK-04: GMCI in combination with nivolumab in first-line glioma
Based on our clinical data and pre-clinical studies demonstrating synergy with antiPD-1 therapy (Speranza et al 2018), and in conjunction with our collaborators at Bristol-Myers Squib Co. (“BMS”) and the Adult Brain Tumor Consortium (ABTC), we have launched a 36 patient phase 1 / 2 clinical trial to study the effects of GMCI in first-line patients in combination with nivolumab, an immune checkpoint inhibitor, marketed by BMS as Opdivo®. This is a dose escalation single-arm clinical study with the primary goal of examining safety. We will also be looking for indications of efficacy including by overall survival, progression free survival, and radiologic changes. Blood and tissue will be examined for immune correlates. The trial is being launched at several ABTC sites, including Johns Hopkins, Cleveland Clinic, and Dana Farber Cancer Institute. Data from this trial will be used to inform the design of a larger, possibly pivotal, clinical study.
BrTK-03: GMCI in Candidates for Gross Total Resection
We anticipate launching a pivotal, randomized, fully blinded, placebo-controlled study evaluating GMCI in patients with newly diagnosed GBM that are candidates for gross total resection.
We believe GMCI is a promising choice for patients, providers, and payors in first malignant glioma because:
Data from our previously conducted Phase 2 trial indicate that GMCI can safely and effectively increase the probability of a patient to have a clinically meaningful and durable response to his or her cancer treatment. Results of this study have been published (Wheeler et al 2016, Chiocca et al 2011).
Accessibility, ease of administration, and safety of the product allow administration with current standard-of-care surgery, radiation, and chemotherapy without additional toxicity, delay, and cost of product production, shipment or administration typically associated with autologous therapies or other viral based immunotherapies
rQNestin Recurrent Glioma
rQNestin Phase 1: A Study of the Treatment of Recurrent Malignant Glioma
This physician-sponsored study has a target enrollment of at least 27 patients that have a recurrence of glioma. The goal of this study is to determine the maximum tolerated dose of rQnestin34.5 in recurrent malignant glioma patients. Endpoints of this study include safety, quality of life, progression free survival by MRI, immune and other correlates. Data from this trial will be used to inform the design of a larger, possibly pivotal, clinical study.