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. As of March 2019, the lead compound was in Phase III trial.

BiondVax Pharmaceuticals Ltd.

Type	Public
Traded as	NASDAQ: BVXV
Industry	Vaccines
Founded	2003 (2003)
Founder	Ron Babecoff
Headquarters	Ness Ziona , Israel
Number of employees	16 (2016)
Website	www.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) has been vaccinated with M-001 or placebo, with the second cohort (n~8,000, total N~12,000) to receive 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 the phase 3 study is scheduled for the first half of 2020, with data analysis likely completed during the second half of 2020.

In March 2018, FDA director Scott Gottlieb said that approval of a universal flu vaccine was years in the future.[14] 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][14]

See also

• Health care in Israel
• Science and technology in Israel

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. Sagonowsky, Eric (March 14, 2018). "After a rough season, FDA chief Gottlieb says 'holy grail' flu shot is years off". FiercePharma.