Israel institute inks MOU to complete BriLife blue-and-white COVID vaccine

The Israel Institute for Biological Research has signed a memorandum of understanding (MOU) with a US-based pharmaceutical company to help fast-track Israel’s BriLife vaccine, the Defense Ministry announced Monday.

The “bri” is the first part of the Hebrew word for health; the “il” stands for Israel and “life.” IIBR operates under the auspices of the Prime Minister’s Office and works closely with the Defense Ministry.

“This agreement is excellent news for Israel’s citizens and highlights the unprecedented achievement of the Israel Institute for Biological Research,” said Defense Minister Benny Gantz. “I anticipate that with this agreement, we will be able to complete the development of the vaccine and enable Israel to produce vaccines independently, because as we have seen recently – the coronavirus is not going anywhere.”

The agreement was struck with Nasdaq-traded NRx Pharmaceuticals and gives the company exclusive worldwide development, manufacturing and marketing rights, NRx said. The company will conduct rapid Phase IIb/III testing in Ukraine, Georgia and Israel.

IIBR will continue to stay involved in the process, share knowledge and provide scientific assistance to complete the clinical trials as needed. The institute will also receive customary royalty and milestone payments for its intellectual property.

NRx committed to supplying Israel with any required doses of the vaccine if and when it is completed, the company said.

The deal was approved by the Finance Ministry.

The BriLife vaccine has been plagued by a series of delays since IIBR began attempting to develop it more than a year-and-a-half ago. Originally, the plan was to have a vaccine available by this summer.

To date, the vaccine is mid-way through its Phase II trial, according to Prof. Eytan Ben-Ami, head of early phase clinical trials at Sheba Medical Center, who has been heading the initiative for the hospital. The Phase II trial was approved and kicked off in December 2020, around the time that the first vaccines arrived in Israel.

Ben-Ami told The Jerusalem Post that another roughly 100 volunteers still need to be recruited to complete the last arm of the trial, testing what is known as a “top dose” or higher dose that researchers were hoping would improve the vaccine’s efficacy.

Until now, the team had tested low, medium and high doses.

“The next steps would be to see the efficacy [of the vaccine],” Ben-Ami said. “We know it is safe and now we have to see if it is good enough after we analyze all the doses and the groups to see if it is good enough to go to Phase III.”

He said if continued at its current pace, he expects Phase II would take another minimum of eight weeks and it would be at least three months before “even the decision” to go to a Phase III trial could be made.

BriLife is a vector-based vaccine. The vaccine takes the vesicular stomatitis virus (VSV) and genetically engineers it so that it will express the spike protein of the novel coronavirus on its envelope.

Once injected, it does not cause a disease by itself. VSV does not infect humans; instead, the body recognizes the spike protein that is expressed on the envelope and begins to develop an immunological response. The vaccine will initially be delivered by traditional injection, NRx said in a release.

On NRx’s side, the initiative will be led by NRx chairman and CEO Jonathan Javitt and NRx director Chaim Hurvitz, who chairs CH Health, an Israeli Private Equity group.

“As the first generation COVID vaccines are increasingly challenged by rapid mutation of the coronavirus,” Hurvitz said, “we aim to develop a vaccine that can rapidly scale at low cost to serve the needs of both the developed and the developing world.”