�VaxInnate Corporation announced that its M2e universal flu vaccine prospect was safe and immunogenic in its first Phase I clinical trial, raising hopes for a universal influenza vaccine that could provide security against seasonal and pandemic influenza strains.
"We'd characterise VaxInnate's M2e universal grippe vaccine prospect as selfsame promising, based upon the immune responses and tolerability we power saw in the clinical trial participants," said Christine Turley, MD, Director of clinical trials and clinical inquiry at the Sealy Center for Vaccine Development, University of Texas Medical Branch (UTMB), and the study's primary police detective. "UTMB is committed to further studies of VaxInnate's vaccine candidate, which has the electric potential to be a safe, highly effective and much-needed option to prevent seasonal worker and pandemic influenza A."
The run is a milestone for both the vaccine candidate and for VaxInnate, according to CEO Alan Shaw, PhD.
"We're very pleased with the study data, which present that VaxInnate's M2e universal flu vaccine candidate is safe and capable of eliciting a more potent immune response by delivering a 'one-two punch' that triggers both arms of the body's immune doD," Dr. Shaw said. "Furthermore, it accomplishes this at doses below a microgram of vaccine antigen and without the use of conventional adjuvants. In brusque, this vaccine candidate has passed a critical initial test with data that have exceeded our expectations."
The results of the study testament be presented at the joint Interscience Conference on Antimicrobial Agents and Chemotherapy/Infectious Diseases Society of America (ICAAC/IDSA) meeting in October. UTMB and VaxInnate researchers are likewise collaborating on a holograph for submission to a peer-reviewed journal. To avoid jeopardizing the presentation and publication of the clinical data, further details of the study are non being disclosed at this time.
Sixty healthy loretta Young adults participated in the double-blind, dose-escalating Phase I study, which was intentional to assess the safety and immunogenicity -- a patient's ability to engender an immune response -- of the M2e universal influenza vaccine candidate in dosages of 0.3, 1, 3 and 10 ug injected 28 days apart.
The trial was also intentional to assess VaxInnate's approach to development and producing flu vaccines, which is based upon a proprietorship combination of toll-like receptor-mediated immune enhancement and recombinant bacterial output of vaccine antigen. This proprietary engineering could significantly reduce the time required to produce vaccine supplies sufficient to meet national and fifty-fifty global inevitably.
VaxInnate's utilisation of bacterial expression for production of influenza vaccines does not require costly expansion of manufacturing capacity, as do other influenza vaccine products. Due to its efficiency and transferability, VaxInnate's grippe vaccine could instead be produced in existing biotechnology facilities that have microbial production capacity.
No other vaccine engineering in habit or in development today has these same potency capabilities.
The study was supported by a $9.5 million grant awarded to UTMB by the Bill & Melinda Gates Foundation, for better control of flu epidemics in the developing world.
VaxInnate's Approach and the M2e Universal Vaccine Candidate A universal flu vaccine would provide auspices against all strains of seasonal and pandemic influenza A without needing to be renewed annually. While universal inoculation has been proposed to improve vaccination coverage and prevent disease, there ar no universal vaccines at this time. Nor is there a means of developing and producing the volume of vaccine necessary to follow through universal influenza vaccine recommendations.
VaxInnate's linguistic universal influenza vaccine candidate is designed to target the ectodomain of the M2 protein (M2e), an ion channel protein found on the open of grippe A viruses. M2e is the about highly conserved surface protein of the virus, thereby eliminating the need for epidemiologists to identify and predict strain variants that emerge from year to year, as they mustiness now.
In developing traditional vaccines, epidemiologists must forebode months in advance which flu strains will be circulating during the following fall and winter season in order to formulate a vaccinum that targets the likeliest candidates. The selected strains are then manufactured in live, fertilized chicken egg using a laborious process that takes 6 to 9 months.
Federally-funded alternate approaches that are now in development, such as cell-based product, also take 6 months and would require large, committed fabrication facilities.
Using egg- or even cell-based means, the time necessary to produce flu vaccinum today would make it difficult to respond to public health emergencies, such as the emergence of a pandemic flu, and impossible to reformulate vaccinum if circulating strains do not match those in the vaccinum, as was the example during the most recent 2007-2008 grippe season.
Unlike technology that uses egg or cells for vaccine production, VaxInnate's technology is based upon the formulation in recombinant bacteria of relevant grippe virus protein antigens consolidated to the bacterial protein flagellin. Flagellin interacts with the resistant system's toll-like receptors (TLRs), which affair in human immune cells as sentries that notice pathogens and mount a general immune defense. This initial defense releases cytokines and other signals that in turn stimulate a second, stronger adaptive immune response, including production of pathogen-specific antibodies. VaxInnate scientists believe their technology will produce flu vaccine of heretofore spiritual world quality that can be rapidly and inexpensively produced in volumes sufficient to achieve universal vaccination.
About VaxInnate VaxInnate is a privately-held bioengineering company in Cranbury, NJ and New Haven, CT that is pioneering breakthrough technology for use in developing novel, proprietary vaccines for seasonal worker and pandemic influenza. This novel technology has the potential to dramatically improve the authorization, manufacturing capacity and cost-effectiveness of influenza vaccines.
In addition to the M2e universal vaccine candidate in clinical development, clinical trials for hemagglutinin (HA)-based seasonal and pandemic influenza vaccine candidates testament begin this year.
VaxInnate's technology platform is besides being investigated for development of vaccines for other diseases.
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