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BiondVax has positive Phase 2b trial for universal flu vaccine

July 20, 2017

BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), and the UNISEC consortium today reported statistically significant positive results from the Phase 2b clinical trial of M-001, BiondVax’s universal flu vaccine candidate.

The study had two primary endpoints: Safety and influenza-specific cellular immune responses. Both endpoints were achieved.

Trial Design: The randomized placebo-controlled double-blind trial consisted of 3 arms; The 219 participants, aged 18 to 60 years, twice received either 0.5mg M-001, 1.0mg M-001, or saline placebo. All participants were then immunized with a partial dose of avian H5N1 pandemic vaccine.

Primary Safety Results: The Company previously reported[1] and today confirms that M-001 has a good safety profile and is well-tolerated.

Primary Cellular Results: TH1 cytokines including Il-2, Interferon-gamma, and TNF-alpha are biological molecules with known anti-viral and anti-influenza virus activity. These cytokines are produced by CD4 immune system cells when activated as part of T-cell dependent immunity. In this trial, T-cell (also known as cellular) immunity was measured at baseline (prior to immunization), and after immunization with M-001. Compared to the placebo group, statistically significant elevated T-cell dependent immune responses were found in both dosage forms, more notably in the 1.0mg dose group.

The study’s secondary endpoint evaluated antibody (HAI) response to avian H5N1 pandemic vaccination after M-001 or placebo administration. In one of the four H5N1 strains tested, a statistically significant HAI elevation was observed in participants who had received M-001.

Immunological assays and statistical analysis were performed by various UNISEC[2] consortium partners. Dr. Ed Schmidt, Executive Manager of the UNISEC consortium, commented, “The development of universal influenza vaccines can be highly successful when public health institutes and companies work together, share expertise, technologies, and networks. In the UNISEC consortium, we are very pleased to have BiondVax with their M-001 vaccine as one of our partners. The cell mediated immunity observed in our Phase IIB clinical study with the M-001 vaccine is very impressive and of high scientific interest. We are certainly looking forward to continuing this collaboration with BiondVax.

In light of these encouraging clinical trial results that confirm previous study results, the recent €20 million EIB funding[3], the Israel Ministry of Economy grant approval[4], and following consultations with leading European and American regulatory experts, BiondVax is considering taking the opportunity to proceed directly to testing the clinical efficacy of vaccination with M-001 alone in a pivotal Phase 3 clinical trial. Clinical efficacy is planned to be assessed by measuring reduction of flu illness rate and severity.

Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer (CSO), noted, “These significant results confirm that the M-001 is a unique and innovative influenza vaccine that elicits strong Tcell responses and is expected to provide multi-strain and multi-season protection against influenza illness. Along with the substantial funding recently brought to BiondVax we can now concentrate on performing all activities needed to launch the pivotal Phase 3 clinical trial.


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