FP01 Influenza

Overview of Current Influenza Treatments

Traditional Influenza vaccines promote “humoral immunity” that results in the generation of antibodies against proteins that are present on the outer surface of the influenza virus. Such vaccines must be developed on an ongoing basis to respond to the rapid mutation of the dominant antigens on the viral envelope that occurs between flu seasons and, more dramatically, during the emergence of pandemic strains.

The main limitation of this approach is that new seasonal vaccines can only be produced once the influenza strains predicted  to circulate during the next season have been recommended by the surveillance organisations such as the CDC or WHOConsequently, there is a significant lag period before manufactured vaccine is available following identification of the circulating strain.  This is a particularly crucial issue for pandemic outbreaks. In addition, these vaccines can often be quite dissimilar to the actual circulating strains which can significantly limit their effectiveness. Furthermore, conventional vaccination of one of the most at-risk population groups, the over 65s, is relatively inefficient, providing protection for just 30-50% of vaccinated individuals.

Towards a pan-influenza strain vaccine

The regulatory authorities and vaccine governing bodies including FDA, EMA and WHO have repeatedly called for an Influenza vaccine that can provide long-term, prophylactic protection against multiple strains of both seasonal and pandemic Influenza. Such a product would need to provide broad population protection, be effective among at-risk groups, require infrequent dosing, would be suitable for stockpiling for pandemic protection, and be amenable to rapid, relatively inexpensive large-scale manufacturing processes.

Flunisyn™ successfully addresses all of these criteria.

Flunisyn™ – DepoVaccine to protect against Influenza

Flunisyn™ is a DepoVaccine constructed from six Densigens which are derived from highly conserved regions within the core proteins of the Influenza-A virus. On injection, Flunisyn™ forms an intramuscular depot where the Densigens are taken up by antigen presenting cells, processed and presented to T-cells.

Flunisyn™ is in Phase I/IIa clinical study to assess its ability to elicit prophylactic protection against multiple Influenza A strains. Results to date show that FlunisynTM is safe and well tolerated in healthy younger adults and generated strong T-cell responses capable of reacting to many different influenza A strains (including pandemic and zoonotic strains such as avian and swine flu).

Flunisyn™ is designed to address the key demands of main regulatory and governing bodies such as the FDA/EMA/WHO which include:

  1. long-term, prophylactic protection against multiple strains of both seasonal and pandemic Influenza,
  2. effectiveness for at-risk groups,
  3. amenability to infrequent dosing
  4. potential for combined vaccination with traditional vaccines
  5. inexpensive, large scale manufacture and stockpiling potential for global population coverage and management of pandemic outbreaks.