VBI Vaccines Inc. announced the first patients have been dosed in the randomized, controlled Phase 2b study of VBI's cancer vaccine immunotherapeutic candidate, VBI-1901, in patients with first recurrent GBM (rGBM). Andrew B. Lassman, M.D., Chief of Neuro-Oncology at Columbia University Vagelos College of Physicians and Surgeons, Associate Director for Clinical Trials at the NCI-designated Herbert Irving Comprehensive Cancer Center, and principal investigator of the study, commented, "Based on the pre-clinical and clinical data seen in earlier stages of this study, I look forward to demonstrating the potential value of VBI-1901, relative to current standard of care, in my patients in this next phase of clinical development, with a maximum tumor reduction of 93% relative to baseline; 5 additional patients demonstrated stable disease (SD) for a sustained period of time; All patients with a tumor response (PR or SD) (n=7/16) reached a minimum survival of 12 months; Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care. Patientsts will be randomized in a 1:1 ratio across two study arms: Intradermal VBI-1901 + GM-CSF: 10 ug dose every 4 weeks until clinical disease progression; Monotherapy standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or tolerable toxicity; Endpoints include: Safety and tolerability; Overall survival (OS) -- median and overall; Tumor response rate (TRR); Progression-free survival (PFS); Immunologic responses; Reduction in corticosteroid use relative to baseline; Change in quality of life compared to baseline; Change in quality the U.S. F Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology drugs.