You can read part 1 of this series, Flu vaccine development as a hotbed of innovation: Who knew?, here.
In a speech to his colleagues, Rick Bright, Acting Director of the Influenza division at the Department of Health and Human Services (HHS), highlighted many of the innovations and improvements in influenza vaccine R&D that has occurred over the last 10 years. At the same time, Bright, whose department falls under the authority of the Assistant Secretary for Preparedness and Development (ASPR), emphasized: “There is a need for new, improved influenza vaccines.”
Towards that end, the HHS has set benchmarks related to expanding capacity and establishing a dynamic stockpile of vaccines in order to be able to address a flu pandemic should one arise. A key part of that effort is the HHS’s goal “to improve, optimize and innovate vaccine production technologies.”
Enter Calixar and Virpath
In September, Calixar, a French start-up biotech, and Virpath, an academic lab specializing in influenza vaccine virus research, detailed a new approach that they had developed for manufacturing high-performance vaccines. The two collaborators—both based in Lyons, France—have created a new technological and chemical approach to splitting the influenza virus’ membrane for preparation of vaccine formulations that tackle three or four strains of the virus. The new method yields improved preservation of antigen conformation, resulting in a vaccine formulation that is significantly more active than currently marketed vaccines in terms of immunogenicity and in vivo protection.
Emmanuel Dejean, CEO and President of Calixar, spoke to BioPharma Dive about this pioneering approach in an interview. "Our formulation shows high quality and performance when compared to current vaccines on the market," he said. "The antigens are better preserved and consequently, they are more immunogenic. Our new process of production should be faster, making it possible to deliver more effective vaccines in shorter lead times.”
An H1N1 formulation
The first vaccine formulation that the Calixar/Virpath team has developed is an egg-derived antigen formulation directed against the H1N1 virus, which has been an epidemic virus since 2010. This formulation has been shown to be six times more active than other H1N1 vaccines. Importantly, the WHO has recommended that this season's trivalent vaccine should contain an A/California/7/2009 (H1N1)-like virus as part of the formulation for this year's batch.
Calixar is planning to out-license its influenza vaccination manufacturing technology by early 2015. “Our formulation and the new process to produce the split of antigens can be used by any manufacturers, once they are registered by regulators,” said Dejean.
Towards a universal vaccine
Calixar and Virpath are currently working on two other human strains that are part of the annual vaccine composition (H3N2 and influenza B). They are also working on several avian and swine strains. In addition, this highly collaborative team is chasing the holy grail of flu shots: a universal vaccine against influenza.
A universal vaccine is one that can be used by all population and would provide safe, effective, and long-lasting immunity against a broad spectrum of influenza viruses. Ideally, such a vaccine would foster an environment in which everyone who is vaccinated would be immune to emerging viruses and therefore less vulnerable to virulent influenza strains and large-scale outbreaks.
Dr. Barry Mennen, a Washington, DC-based physician, is hopeful that universal vaccines will soon be available. “The great hope is that a universal influenza vaccine is proven safe and effective," said Mennen in an interview. "Here, antibodies would be generated to proteins that remain unchanged from strain to strain and year to year. The FDA has completed the evaluation in animals of one such product and will move on to the next stage of testing. This would be a brilliant advance."