BiondVax Pharmaceuticals Ltd. (TASE: BNDX) today announced positive results from its first Phase II clinical trial of the Multimeric-001 Universal Influenza Vaccine. The vaccine was found to be safe and well tolerated, and induced robust immune responses, successfully meeting both the primary safety and immunogenicity endpoints, as well as additional secondary immunogenicity endpoints. It was also found that the Multimeric-001, when used in conjunction with a commercially available strain-dependant seasonal influenza vaccine (trivalent inactivated vaccine, or TIV), enhances the performance of the TIV by increasing the rates of Hemagglutination Inhibition (HI) seroconversion to influenza strains both included, and not-included, in the TIV itself.
Dr. Ron Babecoff, BiondVax's CEO, said "We are very excited with these positive Phase IIa results. We have confirmed, in what is to our knowledge the first Phase II study of a universal influenza vaccine ever conducted in the world, that the Multimeric-001 vaccine is not only safe and immunogenic on its own, but it also has the potential to enhance the performance of traditional strain-dependant flu vaccines. We are more convinced than ever that this product will provide real benefit to people all over the world, bringing the ultimate goal of a universal influenza vaccine closer than ever before."
This Phase IIa trial was a randomized, double-blind, placebo-controlled study in 200 healthy volunteers conducted at two clinical research centers in Israel - the Hadassah University Hospital in Jerusalem and the Tel Aviv Sourasky Medical Center.
The Multimeric-001 vaccine was safe and well tolerated, thus meeting the first primary endpoint of the study. No vaccine-related severe adverse events were found in any of the participants, nor were there any significant differences between treatment and control groups. These findings further reinforce the positive safety profile of the Multimeric-001 vaccine reported in the Company's Phase I/II trials.
The vaccine also induced both humoral (antibody) and cell-mediated immune responses, further confirming previous results from the Phase I/II clinical trials. Participants who received two doses of the Multimeric-001 vaccine, in an adjuvanted 500mcg formulation, showed a statistically significant increase in the level of IgG antibodies against the Multimeric-001 vaccine, thus meeting the second primary endpoint of the study. It was also found that the Multimeric-001 vaccine caused a statistically significant elevation in the secretion of Interferon-gamma (a known anti-viral agent) to the Multimeric-001, meeting one of the secondary endpoints.
In addition, the Multimeric-001 vaccine, when administered once concomitantly with a 50% dose of a seasonal TIV, also induced higher rates of hemagglutination inhibition (HI) antibody responses (a surrogate marker of protection against influenza infection which is accepted by the regulatory authorities), when compared with the TIV alone. These results confirm the findings from the Phase I/II trial in older adults completed in April 2010, and again show that the combination of the Multimeric-001 vaccine with the TIV has the potential to increase the number of people who reach the HI seroconversion levels required by the US and European regulatory authorities for licensure of influenza vaccines, than when compared with the TIV alone. Importantly, this increase in HI seroconversion rates has been observed not only against strains that were included in the TIV, but also against additional Type A (H1N1 and H3N2) and Type B influenza strains that were not included in the TIV.
These results suggest that the Multimeric-001 has the potential, when administered in advance of future seasonal or pandemic influenza outbreaks, to raise the general level of preparedness of the population and thereby significantly improve the protection and broaden the cross-strain coverage offered by the strain-dependant influenza vaccines.
In light of the successful conclusion of this Phase IIa clinical trial, BiondVax is preparing to conduct the next Phase II trial, in the elderly - the population group most at risk for influenza infections, and for whom current influenza vaccines are least effective. It is expected that this trial will be conducted in two centers in Israel, in around 110 male and female participants aged 65 and over. This trial is expected to commence in the fourth quarter of 2011 and to be concluded in the first quarter of 2012.
Dr. Tamar Ben Yedidia, BiondVax's Chief Scientific Officer, notes that, "the results of this Phase IIa trial are most gratifying. We have now shown, in three clinical trials in over 320 participants, that the Multimeric-001 vaccine is safe and effectively activates the immune system, both on its own as well as in conjunction with the traditional flu vaccines. This gives us much confidence as we proceed with further Phase II and Phase III studies."
Dr. Ben Yedidia will be presenting the results of this Phase IIa clinical trial at the BIO International Convention in Washington DC, USA, on 29 June 2011, in a presentation entitled "Clinical Progress Towards the Development of a Universal Influenza Vaccine".
BiondVax Pharmaceuticals Ltd.