BiondVax

BiondVax Pharmaceuticals Ltd. is an Israeli biopharmaceutical company developing a universal influenza vaccine called M-001. BiondVax is a publicly traded company, listed on the NASDAQ. The vaccine technology was invented in the 1990s at the Weizmann Institute of Science in the laboratory of Ruth Arnon, and was licensed to BiondVax in 2003.

BiondVax Pharmaceuticals Ltd.
TypePublic
NASDAQ: BVXV
IndustryVaccines
Founded2003 (2003)
FounderRon Babecoff
Headquarters
Ness Ziona
,
Israel
Number of employees
16 (2016)
Websitewww.biondvax.com

History

The company's approach to developing a universal influenza vaccine was invented at the Weizmann Institute; it was the subject of Tamar Ben-Yedidia's PhD research under the supervision of Ruth Arnon. Ron Babecoff approached Weizmann in 2002 looking for opportunities to develop and in 2003 his startup, BiondVax, licensed the patents that Yeda, the technology transfer subsidiary of Weizmann, had filed on the vaccine candidate. BiondVax took space in the Weizmann Science Park in Ness Ziona, Israel, Babecoff took the role of chief executive officer, and Ben-Yedidia became the chief scientific officer.[1][2][3]

The company's candidate universal flu vaccine, Multimeric-001 (M-001), is a mixture of 9 peptides, each no longer than 22 amino acids, that are epitopes of HA, NP and M1 proteins of both Type-A and Type-B influenza viruses.[4]

BiondVax was listed on the Tel Aviv Stock Exchange in 2007[5] and started trading as BVXV on the NASDAQ in 2015.[6] Like many early-stage biotech companies its stock fluctuated wildly; BiondVax's stock price shot up in response to the perceived threat of the 2009 swine flu pandemic.[7]

The company was in Phase II trials by 2011.[7] All six phase 2 trials have demonstrated safety and significant immunogenicity. BiondVax was developing M-001 first as a primer to make standard flu vaccines more effective, and secondarily as a vaccine.[8] In 2011, Biondvax administered M-001 to participants who were aged 65 and older as part of one of their phase 2 studies (BVX-005). Four years later, five times more seniors vaccinated with M-001 vs. placebo controls were sero-protected from a new epidemic strain (A/Swiss) that didn’t exist in 2011.

In 2017, the company voluntarily delisted from the Tel Aviv exchange in favor of the NASDAQ.[9] Earlier that year, the fund of Check Point's Co-founder and Chairman Marius Nacht became BiondVax's largest shareholder.[10] In 2017 it also obtained a €20 million interest-free loan from European Investment Bank, to be paid in three tranches depending on BiondVax hitting defined milestones, with the last one being approval to start a Phase III trial of its lead candidate.[11] The European Investment Bank increased the non-dilutive, interest-free loan to €24 million, all of which has been distributed to BiondVax. The company used the new funds to build a manufacturing facility in Jerusalem and to do further drug development work.[12][13]

In October 2018, BiondVax began a two year phase 3 study that the European Medicines Agency (EMA) has designated as "pivotal" for the purpose of approval. The first of two cohorts aged 50 and older (n=4,098) was vaccinated with M-001 or placebo, with the second cohort (n~8,000, total N~12,000) having received M-001 inoculations or placebo at the beginning of the 2019-2020 influenza season. BiondVax's M-001 is the first (and thus far the only) universal influenza vaccine candidate to have begun phase 3 trials. Completion of data collection for the phase 3 study was accomplished by June 2020, with data analysis expected to be complete between end of September and end of October 2020. In October 2020, they released data analysis indicating that the vaccine failed to demonstrate a statistical difference in reduction of flu illness and severity between the vaccinated and the placebo groups, and that it had failed to meet the efficacy endpoints. [14] As a result, the company's stock price fell 90% the day following the announcement. [15]

In March 2018, FDA director Scott Gottlieb said that approval of a universal flu vaccine was years in the future.[16] Other groups pursuing similar products at that time included Sanofi which had recently acquired Protein Sciences and its candidate, Johnson & Johnson, Vaccitech, Inovio Pharmaceuticals, and several government and academic labs.[4][16]

See also

References
  1. Weinreb, Gali (28 July 2013). "Yeda earns $50-100m annually". Globes.
  2. "Prosepectus". BiondVax via SEC Edgar. February 2, 2016.
  3. "In conversation with Ron Babecoff". BioTuesdays.com. October 14, 2014. Archived from the original on 20 May 2016. Retrieved 15 March 2016.
  4. Halford, Bethany (2018-03-12). "In search of a universal flu vaccine". Chemical & Engineering News.
  5. Weinreb, Gali (June 12, 2007). "Biotech cos succeed in recent TASE offerings". Globes.
  6. "BiondVax Pharmaceuticals Ltd. (BVXV) IPO". NASDAQ. Retrieved 15 March 2016.
  7. Dichek, Bernard (23 August 2011). "Can a Hollywood horror movie influence drug development?". Nature Biotechnology Blog: Trade Secrets.
  8. Liu, Angus (June 19, 2017). "BiondVax nabs €20M loan to advance universal flu vaccine". FiercePharma.
  9. Globes correspondent (31 August 2017). "Universal flu vaccine co BiondVax to delist from TASE". Globes.
  10. Globes correspondent (2 January 2017). "Marius Nacht fund invests NIS 10.9m in BiondVax". Globes.
  11. "Press release: Israel: EIB supports Late-Stage Development and Production of BiondVax's Universal Flu Vaccine Candidate". European Investment Bank. 19 June 2017.
  12. Macdonald, Gareth (18 July 2017). "BiondVax leases site for universal flu vaccine plant in Israel". Biopharma Reporter.
  13. Palmer, Eric (March 30, 2017). "Israeli biotech BiondVax gets government help to build flu vaccine manufacturing facility". FiercePharma.
  14. Phillipson, Josh. "BiondVax Announces Topline Results from Phase 3 Clinical Trial of the M-001 Universal Influenza Vaccine Candidate". BiondVax. BiondVax.
  15. Bakiny, Prosper Junior (23 October 2020). "Why BiondVax Pharmaceuticals Stock Imploded Today". The Motley Fool.
  16. Sagonowsky, Eric (March 14, 2018). "After a rough season, FDA chief Gottlieb says 'holy grail' flu shot is years off". FiercePharma.
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