Vascular Biogenics Inc. (NASDAQ: VBLT) stock declined by 8.33% at the last close whereas the VBLT stock price gained by 5.37% in the after-hours session. VBL Therapeutics, a subsidiary of Vascular Biogenics Ltd. is a clinical-stage biopharmaceutical business focusing on the research, production, and marketing of first-in-class medicines for cancer and immune/inflammatory diseases.
On June 3, 2021, Vascular Biogenics announced that a major endpoint change in the OVAL Phase 3 registration-enabling trial of VB-111. In addition to the trial’s initial primary goal, overall survival, the clinical trial modification includes a second, distinct primary objective, progression-free survival (PFS) (OS). Based on the U.S. government’s examination of the revisions, successfully satisfying either main goal is expected to be adequate for BLA filing by the Food and Drug Administration (FDA).
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The successful completion of the PFS endpoint, with a readout expected in 2022, might cut the time it takes to submit a BLA by about a year, compared to previous expectations based on the readout of the OS primary endpoint, which is still expected in 2023. The OVAL study modification was supposed to be presented on June 4, 2021, as part of a virtual Clinical Trial in Progress poster presentation at the 2021 ASCO Annual Meeting, including an update on the number of patients enrolled, which topped 260 as of April 30, 2021.
VB-111 is an experimental anti-cancer gene therapy that is being tested to treat a variety of solid tumors. VB-111 is a one-of-a-kind biologic drug that targets solid tumors via two mechanisms. It works by combining tumor vascular blockage with an anti-tumor immune response.
Bradley Monk, FACOG, Arizona Oncology, and Chair of the OVAL Study Steering Committee stated:
PFS as a second independent main objective has a number of significant implications for the OVAL research. First, it lowers the study’s risk by providing two scenarios for success. Second, because PFS results are due in 2022, it should shorten the period between trial readout and eventual approval. Third, preserving OS as the primary objective allows VB-111 to be distinguished from current ovarian cancer medications, which were authorized based on PFS results but have yet to show an OS advantage.