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Press Release

May 02, 2022
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FDA grants fast track designation to ofranergene obadenovec for advanced ovarian cancer

Source:

Press Release

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The FDA granted fast track designation to ofranergene obadenovec in combination with paclitaxel for treatment of platinum-resistant ovarian cancer.

Ofranergene obadenovec (VB-111, VBL Therapeutics), often called ofra-vec, is an investigational gene therapy in development to treat solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor response, according to a VBL Therapeutics-issued press release.

Sign outside FDA HQ in Washington, DC.
Source: Adobe Stock.

The agent appeared well-tolerated in a phase 1 trial that included more than 300 people with cancer. It also has demonstrated activity in an “all comers” phase 1 trial and three tumor-specific phase 2 trials, according to the release.

VBL completed enrollment of 409 patients in the randomized phase 3 OVAL trial, which will evaluate the agent for women with recurrent platinum-resistant ovarian cancer. Researchers will assign women to paclitaxel plus either ofra-vec or placebo.

PFS and OS will serve as primary endpoints.

“The fast track designation can facilitate the process towards potential registration and, importantly, may help expedite the time to market for ofra-vec, if approved,” Professor Dror Harats, MD, CEO of VBL Therapeutics, said in the release. “The readout of the progression-free survival primary endpoint in the OVAL trial will be an important milestone for VBL in the second half of this year. We believe that, if positive, this will support a biologics license application submission to the FDA.”

Topline OS data are anticipated in 2023.

The FDA previously granted the agent fast track designation for treatment of recurrent glioblastoma and platinum-resistant ovarian cancer.