GREFFEX HAS BEEN DEVELOPING BROAD BIOTERROR VACCINES

February 1, 2015

In North America and Europe approximately 940 million people are at risk of bioterrorism agents. According to the World Health Organization, its committee of experts’ estimates that an aircraft release of 50 kg of anthrax spores over an urban developed population of 5 million would result in about 250,000 deaths and an additional 125,000 would be severely incapacitated.

To protect major population centers, it will therefore be necessary to provide anthrax vaccines to a large segment of the population. In the US alone, billions of dollars have been budgeted for medical countermeasures to terrorism agents and to stockpile anthrax vaccines for a “three-city attack”. The problem with the presently available anthrax vaccine is its low immunogenicity. Several booster injections are required over a one-year period to establish immunity.

Greffex produced the anthrax vaccine GreANX based on its GreVAX Universal Platform. This anthrax vaccine has successfully undergone preclinical testing.

Another infectious agent with a bioterror threat potential similar to anthrax, is the plague. Greffex has been constructing the GrePla candidate vaccine as a single target vaccine that can be combined with GreANX for immunization. In parallel, Greffex has assembled GreVAX-based vaccine, GreAnPla, that carries antigens for anthrax and plaque on a single construct. This approach allows increased efficiency in manufacture and vaccination.

NIAID TESTS GREFFEX’S AVIAN FLU (H5N1) VACCINE

January 9, 2015

In studies sponsored by the National Institute of Allergy and Infectious Disease (NIAID), Greffex’s GreFluVie vaccine proved to be highly effective in protecting animals against H5N1. Mice were immunized in a prime/boost schedule before being challenged with a lethal dose of the pandemic avian influenza virus. At the low dose of 3×108 genome equivalents, the vaccine proved to be highly effective when given by intramuscular, subcutaneous, and intranasal routes. Intramuscular injection resulted in a rate of survival of 100%.

NIAID TESTS GREFFEX’S MERS-CoV VACCINE

September 4, 2014

In the summer of 2014, Greffex was asked by the National Institute of Allergy and Infectious Diseases (NIAID) for a sample of its vaccine for MERS-CoV so that it could run tests to evaluate the production of neutralizing antibodies.

On a very tight schedule (less than two months) Greffex produced, purified, and vaccinated animals with the GreMERSfi. Mice were immunized in a prime/boost schedule with a small dose (approx. 3×108 genome equivalents).  A standard micro-neutralization assay was used to quantify the humoral immune responses. All of the animals raised significant levels of neutralizing antibodies. 75% of the animals presented with very high antibody titers in the range of 640 to more than 2,560 (the test limit).  In light of these results, the NIAID has invited Greffex to request further trials under its sponsorship.

MERS: GREFFEX DOES IT AGAIN

MERS-CoV: In one month Greffex builds an advanced vaccine against the Middle East Respiratory Syndrome coronavirusAURORA, Colorado, June 24, 2013

MERS-CoV: In one month Greffex builds an advanced vaccine against the Middle East Respiratory Syndrome coronavirus

A scant two months after creating the first comprehensive vaccine for H7N9 avian influenza, Greffex developed a vaccine to protect against the Middle East Respiratory Syndrome coronavirus (MERS-CoV.) The vaccine was readied in just four weeks after MERS-CoV had moved to the WHO’s “alert phase” that also includes the human bird flu viruses H5N1 and H7N9.   

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“We have big competitors who claim they can initiate vaccine production faster than we can,” says Dr. Uwe D. Staerz, Chief Scientific Officer at Greffex. “That they can go from algorithm to gene synthesis in matter of days invoking synthetic biology. But after they’ve constructed the necessary genes, they still need several months to deliver an actual vaccine. Once we get the genetic information for a new virus, we can give you a testable vaccine in a month. Our platform is therefore ideally suited to combat fast emerging infections. ”

First reported in September 2012 in Jeddah, Saudi Arabia, MERS was confirmed in 64 cases and caused 38 deaths, according to a recent WHO report. A member of the coronavirus family—which includes common cold viruses and the Severe Acute Respiratory Syndrome (SARS) virus—MERS cases have recently appeared in Europe among travelers from the Middle East. “International concern about these infections is high, ” the WHO said recently of MERS.

Greffex’ unrivalled production times result from its proprietary GREVAX platform—a highly scalable process that also safeguards vaccine purity. Developed with the support of the National Institutes of Health and the National Institute of Standards and Technology, GREVAXTM vaccines are designed as small synthetic nanoparticles of genes packaged in an adenoviral shells that can be modified to deliver their genetic payloads wherever most beneficial. They can be administered in different ways, including injection and nasal mist.

“Our vaccines target cells that kick start the immune system and do not need chemical adjuvants,” says Staerz. “We have a clean product that does not expose you to contaminations from insect or plant proteins as seen in other systems.”

Taking advantage of the immunogenicity of the benign adenovirus, the GREVAX platform produces vaccines more efficiently than conventional approaches. Its economy gives Greffex the agility to ramp up production in response to a sudden pandemic or threat. “It’s true that DNA vaccines can be produced in the same time frame. But their delivery methods are limited,” says John R. Price, President and Chief Executive Officer of Greffex. “We’ve worked very hard to be able to make a vaccine in a month. The real problem we all face is: can you make 100 million doses in a short span of time, in a small space, and at a reasonable price? We can. We are in the position to swiftly scale up production to these levels.”

Greffex has created a vibrant pipeline of vaccines and is preparing its H5N1 avian influenza vaccine for clinical trials. Its library already contains vaccines against different influenza strains, Anthrax, Dengue, Ebola and now MERS. It is constantly being expanded as the construction of new candidates was simplified to a few engineering steps and the production of vaccines was adapted to standardized manufacturing protocols.

The GREVAXTM platform combines a flexible ‘plug-and-play’TM design accommodating different antigens, such as the MERS-CoV major surface S protein gene, with shortened development times of less than one month.

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For more information about Greffex and its GREVAXTM vaccines, please go to our website: www.greffex.com or contact John R. Price at jprice@greffex.com / 303-577-0400.

 

H7N9: Greffex “Beats the Clock” Builds First Comprehensive H7N9 Vaccine

GREVAX H7N9 vaccineAURORA, Colorado, 5/1/13 

BusinessWire | Greffex has completed the construction of the first comprehensive vaccine against the virulent strain of H7N9 avian influenza.

Greffex scientists have created the first comprehensive vaccine for H7N9 avian influenza.  

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Spreading from Shanghai, and transmitted by birds, H7N9 avian influenza is a highly pathological virus that kills nearly 20% of people it infects, making it more lethal than the 1918 “Spanish Flu.” As infected birds display no symptoms, the spread of the virus is difficult to control. While human-to-human transmission of H7N9 is rare, few genetic changes in the virus could greatly enhance contagion and initiate a fast moving pandemic. Keiji Fukuda, Assistant Director-General for health security at the WHO, characterized H7N9 as an “unusually dangerous virus for humans.”

In just one month after the virus had been characterized, Greffex scientists built an H7N9 avian influenza vaccine using its proprietary GREVAXTM technology. Normally development of such a vaccine takes many months. “We believe the world needs a ‘plug-and-play’TM method of creating vaccines,” says Greffex Chief Scientific Officer Dr. Uwe D. Staerz. “Speed as well as flexibility is needed for vaccine design to combat emerged infectious threats. We had already shown with an Anthrax vaccine that we can create ANY vaccine within one month.” 

The GREVAXTM vaccine platform has been purpose-built with support by the NIH and NIST. It integrates short development times, with large payloads, carrying the H7N9 avian influenza hemagglutinin and neuramidase genes, and high levels of plasticity. It focuses the potent immunogenicity of adenovirus-based engineered vaccines to vaccine antigens, as it is fully deleted of adenoviral genes and devoid of helper viruses. Its modules allow a flexible ‘plug-and-play’TM design of vaccines for emerging infectious diseases, including but not limited to the H7N9 avian influenza.

Greffex has a vibrant pipeline of vaccines currently undergoing testing. “We originally created the GREVAXTM system for H1N1 swine influenza, and now have a Dengue vaccine, an Anthrax vaccine, an Ebola vaccine, and avian influenza vaccines, and we have overcome major production and manufacturing obstacles.” says John R. Price, President and Chief Executive Officer of Greffex. “And we are working on a universal influenza vaccine, the “holy grail” of vaccine science.”

See Also:

For more information about the Greffex and its GREVAXTM vaccines, please go to our website: www.greffex.com or contact John R. Price at jprice@greffex.com / 303-577-0400.