Draft:BiondVax
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| Submission declined on 31 March 2016 by DGG (talk). Not acceptable. Excessive detail and does not comply with WP:MEDRS.
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This draft has not been edited in over six months and qualifies to be deleted per CSD G13. Declined by DGG 8 years ago. Last edited by WanderingJosh 6 years ago. Reviewer: Inform author.
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| Submission declined on 17 March 2016 by 333-blue (talk). This submission appears to read more like an advertisement than an entry in an encyclopedia. Encyclopedia articles need to be written from a neutral point of view, and should refer to a range of independent, reliable, published sources, not just to materials produced by the creator of the subject being discussed. This is important so that the article can meet Wikipedia's verifiability policy and the notability of the subject can be established. If you still feel that this subject is worthy of inclusion in Wikipedia, please rewrite your submission to comply with these policies. Declined by 333-blue 8 years ago. | |
Comment: I'm not entirely certain if this company is notable (could be acceptable at best) so I'm asking DGG for his analysis. SwisterTwister talk 04:19, 31 March 2016 (UTC)
| Company type | Public |
|---|---|
| Nasdaq: BVXV | |
| Industry | Biopharmaceutical |
| Founded | 2003 |
| Founder | Dr. Ron Babcoff, DVM |
| Headquarters | , |
Area served | Worldwide |
| Products | Vaccines |
Number of employees | 16 (2016) |
| Website | www |
BiondVax Pharmaceuticals Ltd. is a biopharmaceutical company developing a universal influenza vaccine called M-001.[1]. The vaccine technology was developed in the 1990s at the Weizmann Institute of Science in Rehovot, Israel by Professor Ruth Arnon[2], and was licensed by the Weizmann Weizmann Institute of Science to BiondVax in 2003[3]. As of 2017, BiondVax has completed six clinical trials[4]. The company has stated its intention to conduct a final Phase 2 trial sponsored by the National Institutes of Health in the United States[5], and proceed to a pivotal Phase 3 trial beginning in 2018[6]. BiondVax is a publicly traded company, listed on the NASDAQ[7].
Company
BiondVax was established in 2003 after acquiring a license for a universal influenza vaccine technology developed at the Weizmann Institute. It was co-founded by Dr. Ron Babecoff[8][9], currently the company's CEO and President[10]. Dr. Tamar Ben-Yedidia [11][12] is the company's Chief Scientist Officer, having worked formerly under Professor Ruth Arnon at the Weizmann Institute of Science. The company is headquartered in the Weizmann Science Park in Ness Ziona, Israel.
The company is publicly traded, having listed on the Tel Aviv Stock Exchange in 2007[13], and on the NASDAQ in 2015[14].
In 2017, the European Investment Bank (EIB) announced[15] that they entered into a €20 million loan agreement to support development and production BiondVax's universal flu vaccine candidate. Also in 2017, the fund of Check Point's Co-founder and Chairman Marius Nacht became BiondVax's largest shareholder.[16]
Universal Flu Vaccine
The Company's candidate universal flu vaccine product is called Multimeric-001 (M-001). It is a recombinant protein consisting of 9 conserved epitopes of Type-A and Type-B influenza viruses[17].
BiondVax’s approach uses a combination of conserved epitopes derived from the influenza virus as immunogens, forming the vaccine. The conserved epitopes are common to most human flu virus strains regardless of their antigenic drift and shifts. These conserved epitopes are used to activate the human immune system, enabling it to recognize any type of influenza virus. These conserved epitopes are restricted to the viral structure and are not shared by any human protein, thus they are unlikely to induce an autoimmune phenomenon.
Origins
Current influenza vaccines rely predominantly on triggering immune responses to the variable regions in the influenza envelope protein Hemagglutinin (HA) and consequently, are highly strain-specific.[18]. In the 1990s, Professor Ruth Arnon and colleagues described their approach of identifying conserved (common) immunogenic elements of all influenza viruses, and then combining those elements into one recombinant protein.[19] In 2003, following initial positive results in mouse models, the technology was licensed via Yeda[20] to the newly established BiondVax Pharmaceuticals.
Clinical Trials
M-001 has completed six clinical trials.
| Start Date | Phase | Title | Age Group | Participants | Details/Reference |
|---|---|---|---|---|---|
| June 2009 | 1/2 | A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) | Adult | 63 | link |
| September 2009 | 1/2 | A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers | Adult / Senior | 60 | link |
| July 2010 | 2 | Further Investigation of an Intramuscular Influenza Vaccine (Multimeric-001) | Adult | 200 | link |
| August 2011 | 2 | A Study to Assess the Safety and Immunogenicity of M-001 Influenza Vaccine as a Primer to TIV in Elderly Volunteers | Adult / Senior | 120 | link |
| November 2014 | 2 | Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV | Adult | 37 | link |
| October 2015 | 2b | A Study to Assess the Safety and Immunogenicity of M-001 Influenza Vaccine as a Primer to H5N1 Vaccine in Adults | 18-60 years | 219 | link |
The Phase 2b trial, titled "A Study to Assess the Safety and Immunogenicity of M-001 Influenza Vaccine as a Primer to H5N1 Vaccine in Adults" was sponsored by UNISEC[21][22], the European Universal Influenza Vaccine Consortium. The study had two primary endpoints: Safety and influenza-specific cellular immune responses. Both endpoints were achieved[23].
In November 2017, BiondVax announced[24] a Phase 2 trial titled "A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Trivalent Influenza Vaccine." in collaboration with the NIAID.
References
- ^ Bautz, David. "BVXV: Initiating coverage of BiondVax Pharmaceuticals Ltd.: Developing a Universal Influenza Vaccine". Zacks SCR. Retrieved 14 March 2016.
- ^ "Professor Ruth Arnon". Weizmann Institute of Science. Retrieved 14 March 2016.
- ^ "Investor FAQ". BiondVax. Retrieved 14 March 2016.
- ^ "Clinical Trials". BiondVax. Retrieved 27 March 2016.
- ^ "BiondVax plans Phase 2 test of pandemic primer vaccine". Vaccine News Daily. Retrieved 14 March 2016.
- ^ "BiondVax's CEO Issues Letter to Shareholders". BiondVax. Retrieved 2017-12-27.
- ^ "BiondVax Pharmaceuticals Ltd. American Depositary Shares Quote & Summary Data". NASDAQ. Retrieved 14 March 2016.
- ^ "Ron Babecoff DVM". Bloomberg Business. Retrieved 15 March 2016.
- ^ "In conversation with Ron Babecoff". BioTuesdays.com. October 14, 2014. Retrieved 15 March 2016.
- ^ "Management". BiondVax. Retrieved 15 March 2016.
- ^ "Tamar Ben-Yedidia Ph.D." Bloomberg Business. Retrieved 15 March 2016.
- ^ "Tamar Ben-Yedidia". ResearchGate.net. Retrieved 15 March 2016.
- ^ "Biotech cos succeed in recent TASE offerings". Globes. June 12, 2007. Retrieved 15 March 2016.
- ^ "BIONDVAX PHARMACEUTICALS LTD. (BVXV) IPO". NASDAQ. Retrieved 15 March 2016.
- ^ "Israel: EIB supports Late-Stage Development and Production of BiondVax's Universal Flu Vaccine Candidate". www.eib.org. Retrieved 2017-12-27.
- ^ "Marius Nacht fund invests NIS 10.9m in BiondVax - Globes English". Globes (in Hebrew). Retrieved 2018-02-28.
- ^ Atsmon, Jacob; Ben-Yedidia, Tamar (7 October 2014). "Priming by a novel universal influenza vaccine (Multimeric-001)—A gateway for improving immune response in the elderly population". Vaccine. 32 (44): 5816–5823. Retrieved 14 March 2016.
- ^ Gottlieb, T; Ben-Yedidia, T (2014). "Epitope-based approaches to a universal influenza vaccine". Journal of Autoimmunity. Retrieved 15 March 2016.
- ^ Cohen, Sara; Shafferman, Avigdor. Novel Strategies in the Design and Production of Vaccines. Chapter 4 "Synthetic Recombinant Vaccine Induces Anti-Influenza Long-Term Immunity and Cross-Strain Protection". pp. 23–29.
{{cite book}}: CS1 maint: location (link) - ^ "BiondVax Pharmaceuticals Ltd". Retrieved 15 March 2016.
- ^ "UNISEC consortium launches clinical trial for Universal Influenza Vaccine". Vaccine News Daily. October 21, 2015. Retrieved 15 March 2016.
- ^ Sagonowsky, Eric (September 30, 2015). "BiondVax, EU's UNISEC team up for universal flu jab PhIIb". Fierce Vaccines. Retrieved 15 March 2016.
- ^ "BiondVax Reports Positive Phase 2b Clinical Trial Results for its Universal Flu Vaccine". BiondVax. Retrieved 2017-12-27.
- ^ "BiondVax and NIH sign Clinical Trial Agreement for a Phase 2 trial in the U.S. with BiondVax's Universal Flu Vaccine". BiondVax. Retrieved 2017-12-27.