The United States Patent and Trademark Office (USPTO) has granted US Patent No. 8,133,723, covering Inovio Pharmaceuticals' SynCon universal vaccine related to H1N1 influenza.

The patent granted to the Trustees of The University of Pennsylvania has been licensed exclusively to Inovio under its existing license agreement with the university. The patent includes claims that cover the synthetic consensus H1 antigen and DNA constructs and vaccines that include this antigen, including universal influenza vaccine INO-3510. This patent also covers methods of treating a patient using the SynCon universal influenza vaccine.

Dr J Joseph Kim, Inovio's president and CEO, said, “This patent is significant for Inovio. It validates the patentable novelty of our SynCon technology and vaccines created using this technology. We have filed for additional patents to protect our broad emerging portfolio of SynCon vaccine products against multiple diseases. Furthermore, this issued patent covers an important component of our universal influenza vaccine, which is in clinical development. Inovio's universal flu vaccine is designed to protect against many if not all strains within multiple selected subtypes--most importantly against the perpetually emerging new strains for which there has never been truly preemptive protection.”

Inovio researchers have previously shown that its H1N1 influenza SynCon vaccine provided 100 per cent protection of animals challenged with the 2009 swine origin H1N1 virus and, separately, the H1N1 virus that caused the 1918 Spanish flu that killed over 40 million people. Additional animal studies have also shown that the vaccination generated protective HAI titers against other important H1N1 strains. The first H1N1 human data from Inovio's phase I study of VGX-3150, which consists of SynCon constructs against H1N1 and H5N1, is expected in Q2 2012.

More recently, human clinical study data from Inovio's H5N1 vaccine, designed using the same SynCon technology, demonstrated that the vaccine generated high levels of antigen-specific binding antibodies and exhibited a four-fold or greater rise in geometric mean titers (GMT) in the HAI assay (ranging from 1:20 to 1:80 HAI titers) against six different H5N1 virus strains. A four-fold rise in HAI titers, compared to pre-vaccination, is considered an important indicator of immune activation. An HAI titer of 1:20 is generally regarded as a positive vaccine response; 1:40 or higher is generally associated with protection against influenza in humans. These results also demonstrate the potential to provide universal protection against unmatched, changing strains of influenza. Final H5N1 immune response data from Inovio's phase I study of VGX-3400X is expected in early Q2 2012.

INO-3510 is a synthetically created, prophylactic DNA vaccine based on multiple influenza strains within multiple influenza subtypes. The vaccine combines SynCon vaccine constructs for two important Type A subtypes, H1N1 and H5N1. Rather than specifically matching a single targeted influenza strain within a subtype, like today's conventional influenza vaccines, these constructs are based on a genetic consensus of multiple existing strains within the selected subtype. Thus "universality" is achieved within and across selected subtypes. The vaccine is expected to generate interim Phase I clinical data in Q2 2012.

The challenge of current influenza vaccines is that their protective capability is substantially limited to protecting against the specific influenza strains targeted in any given year – the circulating strains must match the vaccine strains in order for the vaccine to provide protection. Annually, influenza vaccines typically consist of three strains (two Type A, one Type B) estimated to be the primary strains of concern for the upcoming flu season. However, if the chosen strains subsequently mutate, the vaccine may not provide protection against these newly emergent strains in the next flu season. While Type B strains do not evolve as quickly, Type A strains typically change from season to season. By encompassing multiple strains, VGX-3150 circumvents the traditional vaccine model and may potentially protect against changing strains within the targeted subtypes across many seasons.