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VBL Therapeutics Announces Successful Completion Of Pre-IND Meeting With FDA Regarding Proposed Clinical Development Of VB-601

Alignment with FDA on the path forward for the development of VB-601   TEL AVIV, Israel, Sept. 08, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT) announced today the successful completion of a Type B

· 09/08/2020 08:01
  • Alignment with FDA on the path forward for the development of VB-601
     

TEL AVIV, Israel, Sept. 08, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT) announced today the successful completion of a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for VB-601. VB-601 is the Company's lead anti-MOSPD2 antibody for immune-inflammatory indications, for which a briefing package for the pre-IND meeting was submitted in June. Based on the FDA's feedback, VBL plans to advance its IND-enabling activities for VB-601 as planned.

"We are very pleased with the outcome of the pre-IND meeting with the FDA," said Dror Harats, M.D., CEO of VBL Therapeutics. "VB-601 is a first-in-class product candidate that has a completely novel mechanism of action. It can block the ability of monocyte to migrate to inflammatory sites, no matter which molecules try to attract them in. Therefore, it is important that we have reached alignment with the FDA on the path forward for VB-601. With this green light, we plan to continue to advance VB-601, aiming to start a first-in-human study in the second half of 2021."