Vascular Biogenics Ltd (NASDAQ: VBLT) added a second primary objective of PFS (Progression free survival) in its Phase 3 Oval registration enabling trial of VB-111. It is in addition to the original primary objective of overall survival.
The company can submit BLA (Biologics License Application) if it satisfies either primary objective. Vascular Biogenics expects to publish results on successfully meeting the PFS objective in 2022.
An update on the OVAL study amendment
The company can expedite BLA submission in 2022 instead of 2023.
It enrolled over 260 subjects in the OVAL trial as of April 30, 2021. Vascular Biogenics will update the OVAL study amendment at the 2021 ASCO Annual Conference as part of the Virtual Clinical Study.
OVAL Study Steering Committee’s Chair, Bradley Monk, said adding PFS as a second primary objective is essential for OVAL study. It offers two options for achieving success of the trial besides de-risking the clinical study.
PFS also expedites the time to publish the results in 2022 and seeks quick approval. On the other hand, OS as a primary objective helps to differentiate VB-111 from ovarian cancer treatments available in the market.
Vascular Biogenics conducts an OVAL study in alliance with an independent global non-profit organization – GOG Foundation, Inc in patients with PROC (platinum-resistant ovarian cancer). It is to promote excellence in the gynecologic malignancies arena.
Vascular Biogenics develops investigational anti-cancer gene-therapy agent – VB-111 to cure a wide gamut of solid cancers.
It administers VB-111 as an IV infusion every six to eight weeks. The drug demonstrated improved tolerance in more than 300 patients.
ODD for VB-111
Vascular Biogenics received an orphan drug designation (ODD) from the EU for its innovative drug formulation VB-111 to cure ovarian cancer. It already received ODD for VB-111 in the US.
Raises $28.3 million
Vascular Biogenics raised $28.3 million on April 14, 2021, through an underwritten public offering (UPO) of 6.901 million shares. It will use the proceeds for general corporate purposes and working capital needs.
The company appointed Guggenheim Securities, LLC as a book-running manager and Oppenheimer & Co. Inc as a joint book-runner for the UPO. It also selected JonesTrading Institutional Services LLC and Roth Capital Partners as co-managers.