Candidate: BriLife®
Category: VAX
Type: Self-propagating COVID-19 live virus vaccine developed by the Israel Institute for Biological Research (IIBR) under an exclusive license from the Israel Ministry of Defense.
According to NRx, the vaccine differs from other COVID-19 vaccines by presenting the entire COVID-19 spike protein to the body’s immune system. The spike protein complex from variants may be added to the BriLife vaccine as new variants are discovered.
2022 Status: NRx disclosed January 11 that it is designing a phase IIb/III study of the BriLife vaccine as a booster to protect against COVID-19 variants of concern including Omicron. The study is anticipated to begin in the first quarter in Israel and will be expanded in coordination with the health ministries of several countries. NRx also said it was contacted in late December by representatives of the U.S. Department of Health and Human Services and “several” European governments with a request to present Omicron findings.
The company also disclosed that the Israel Ministry of Health recently approved a study investigating the NanoPass MicronJet™ intradermal injection system for BriLife. NanoPass, invented in Israel, uses a patented microneedle system to deliver the vaccine into the skin with minimal discomfort. That approach is especially promising for BriLife, according to NRx, because the vaccine binds to angiotensin-converting enzyme 2 (ACE2) receptors, which are present in significantly larger quantities in human skin cells than in muscle cells where traditional vaccines are injected. Intradermal delivery of BriLife may result in a more robust immune response at substantially lower vaccine dosing, NRx said, citing early data with other vaccines.
“As these studies are moving towards initiation, NRx continues technology transfer and scale-up activities in anticipation of commercial scale manufacture by Q4 2022,” NRx stated.
2021 Status: NRx on November 26 announced the posting of a preprint in medRxiv by IIBR researchers in which sera samples from 10 of 11 patients who showed effective neutralizing antibodies against the original “wild type” SARS-CoV-2 also were shown to neutralize the Delta variant following vaccination with BriLife. A second group of sera drawn from unvaccinated patients who contracted and recovered from COVID-19 showed antibodies against wild-type SARS-CoV-2, followed by a 3.8 fold reduction in neutralizing titers to the Delta variant. However, these latter patients were not selected from a randomized controlled trial, NRx acknowledged.
The IIBR researchers reported that mutations seen in the BriLife vaccine that may be responsible for effectiveness against variants occurred naturally, as a function of the spontaneous acquisition of new characteristics by BriLife: “Spontaneously-acquired mutations such as N501Y and E484D, that occurred during BriLife® development and correspond to naturally-occurring mutations of SARS-CoV-2 variants, may increase the potential of BriLife® to maintain effectiveness against current SARS-CoV-2 variants, and potentially against future variants of concern.”
NRx said it expected to commence a Phase IIb/III registration trial of BriLife immediately after review by the study’s Data Safety Monitoring Board of the Phase II results during the week of November 29.
No Booster Needed—NRx on August 23 confirmed a report in The Times of Israel stating that 230 volunteers who received the highest dosage of the BriLife vaccine were notified that they did not need a third dose of the vaccine as their protection remained high, six months after getting a second dose. However, participants who received lower doses of the BriLife vaccine have been advised to get a booster vaccination with Pfizer or Moderna shots, as those lower dosages do not appear to offer sufficient long-term protection.
Phase IIb Trial Begins—NRx said August 9 that it had initiated a Phase IIb dose-confirmatory trial of the BriLife vaccine against COVID-19 in the nation of Georgia. The trial is being conducted with oversight from the Senator Richard Lugar Center for Public Health Research. The study is designed to confirm the vaccine’s ability to generate an immune response against the COVID-19 Delta variant before entering Phase III trials in multiple nations.
The Phase IIb program will also incorporate a potential intradermal vaccination option where a small quantity of vaccine is placed into the skin instead of a traditional needle injection into a muscle, NRx said.
IIBR PARTNERSHIP—NRx said July 12 that it signed a Memorandum of Understanding with the Government of Israel to license exclusive worldwide development, manufacturing, and marketing rights to a novel Coronavirus vaccine developed by the Israel Institute for Biological Research (IIBR). The BriLife™ vaccine (technical name VSV ΔG1) is based on a previous, FDA-approved vaccine platform that was further optimized by IIBR and targeted towards COVID-19.
The IIBR has agreed to provide technical assistance, while receiving undisclosed “customary” royalty and milestone payments for its intellectual property. NRx further committed to supplying all required doses of the vaccine for the population of Israel.
The development initiative will be led by NRx chairman and CEO Jonathan C. Javitt, MD, together with NRx director Chaim Hurvitz, who chairs CH Health, an Israeli private equity group.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
