Vascular Biogenics Ltd. (VBLT) stock prices were down by 1.44% shortly after market trading commenced on August 30th, 2021. This brought the price per share down to USD$2.06 early on in the trading day.
VBLT Stock Resumes Patient Enrollment
August 30th, 2021 saw VBLT announce the resumption of enrollment of new patients in VB-111 studies in the United States. This development comes immediately with the following authorization from the U.S Food and Drug Administration (FDA) Chemistry, Manufacturing, and Controls (CMC) Group. The FDA authorization will allow for the use of new batches of VB-111 produced in VBL’s commercial-scale GMP Modiin facility in clinical studies in the United States.
OVAL Trial Resumes in the U.S
VBLT stock was notified by the FDA that clinical use for new VB-111 batches in the United States was pending as of June 2021. The technical review would be conducted by the CMC group and would be focused on the comparability of VB-111 manufacturing between difference source sites. The company prepared and, in early August of 2021, submitted the request data and documentation to the FDA. Patient enrollment in the OVAL trial in the United States has been continued on the basis of the company having sufficient FDA-cleared batches.
About the OVAL Trial
The OVAL trial serves to evaluate VB-111 in ovarian cancer. It expects to enroll a total of nearly 400 patients around the world, with 80% of patients having already been recruited. The trial has two primary endpoints, the first of which is progression-free survival (PFS). The study will also be evaluating overall survival (OS) as a primary endpoint.
VBLT Stocks’ Primary Endpoints
The successful meeting of either primary endpoint could serve as the potential basis for a biologics license application (BLA). The meeting of the PFS endpoint has an expected readout by the second half of fiscal 2022. Should things go according to plan, meeting the PFS endpoint could accelerate BLA submissions by almost a full year. This is contingent on discussions with the FDA. Original projections based on the readout of the OS primary endpoint remain anticipated for fiscal 2023.
Future Outlook for VBLT Stock
The company reported a promising quarter, consolidated by the resuming of patient enrollment in the company’s OVAL trial. VBLT stock is poised to capitalize on the opportunities afforded to it within the United States marketspace. Current and potential investors are hopeful that management will be able to leverage the resources at their disposal. This is hoped to facilitate organic growth over the long term.
