�VaxInnate Corporation announced that its M2e universal flu vaccine candidate was good and immunogenic in its first Phase I clinical trial, fosterage hopes for a universal influenza vaccine that could provide protection against seasonal worker and pandemic influenza strains.
"We'd characterise VaxInnate's M2e universal grippe vaccine campaigner as very promising, based upon the immune responses and tolerability we saw in the clinical trial participants," said Christine Turley, MD, Director of clinical trials and clinical research at the Sealy Center for Vaccine Development, University of Texas Medical Branch (UTMB), and the study's primary investigator. "UTMB is committed to further studies of VaxInnate's vaccine candidate, which has the potential to be a safe, highly effective and much-needed option to prevent seasonal and pandemic influenza A."
The trial 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 march that VaxInnate's M2e universal flu vaccinum candidate is safe and capable of eliciting a more potent immune answer by delivering a 'one-two punch' that triggers both arms of the body's immune defense," Dr. Shaw said. "Furthermore, it accomplishes this at doses below a microgram of vaccinum antigen and without the use of conventional adjuvants. In little, this vaccine candidate has passed a critical initial test with data that have exceeded our expectations."
The results of the study will 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 not being disclosed at this time.
Sixty healthy pres 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 generate an immune response -- of the M2e universal influenza vaccinum candidate in dosages of 0.3, 1, 3 and 10 ug injected 28 years 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 production of vaccine antigen. This proprietary engineering could significantly reduce the time required to create vaccine supplies sufficient to meet national and even global necessarily.
VaxInnate's use of bacterial expression for production of influenza vaccines does non require dear expansion of manufacturing capacity, as do other influenza vaccine products. Due to its efficiency and transferability, VaxInnate's influenza vaccine could instead be produced in existing biotechnology facilities that have microbic production capacity.
No other vaccine applied science in enjoyment or in development today has these same potential capabilities.
The study was supported by a $9.5 gazillion grant awarded to UTMB by the Bill & Melinda Gates Foundation, for better control of grippe epidemics in the developing world.
VaxInnate's Approach and the M2e Universal Vaccine Candidate
A universal grippe vaccine would provide tribute against all strains of seasonal and pandemic flu A without needing to be renewed annually. While universal inoculation has been proposed to improve inoculation coverage and prevent disease, there ar no universal vaccines at this meter. Nor is there a means of developing and producing the volume of vaccine necessary to follow through universal influenza vaccine recommendations.
VaxInnate's universal influenza vaccinum candidate is designed to target the ectodomain of the M2 protein (M2e), an ion channel protein found on the surface of flu A viruses. M2e is the to the highest degree highly conserved surface protein of the virus, thereby eliminating the need for epidemiologists to identify and predict mental strain variants that emerge from year to year, as they mustiness now.
In developing traditional vaccines, epidemiologists must bode months in advance which flu strains will be circulating during the following fall and winter season in order to formulate a vaccine 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 alternative approaches that are now in development, such as cell-based production, also take 6 months and would require large, committed manufacturing facilities.
Using egg- or even cell-based means, the time necessary to bring out flu vaccine today would make it difficult to respond to public health emergencies, such as the emergence of a pandemic flu, and impossible to reformulate vaccine if circulating strains do not rival those in the vaccinum, as was the case during the most late 2007-2008 grippe season.
Unlike technology that uses egg or cells for vaccinum production, VaxInnate's technology is based upon the formula in recombinant bacteria of relevant flu virus protein antigens amalgamate to the bacterial protein flagellin. Flagellin interacts with the immune system's toll-like receptors (TLRs), which part in human immune cells as sentries that detect pathogens and mount a general immune defense. This initial defensive structure releases cytokines and early signals that in become stimulate a second, stronger adaptive immune response, including production of pathogen-specific antibodies. VaxInnate scientists believe their technology will produce influenza 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 biotechnology 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 amend the potentiality, manufacturing capacity and cost-effectiveness of influenza vaccines.
In addition to the M2e universal vaccinum candidate in clinical development, clinical trials for hemagglutinin (HA)-based seasonal and pandemic influenza vaccine candidates will begin this year.
VaxInnate's technology weapons platform is besides being investigated for development of vaccines for other diseases.
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