Greetings Friends and Colleagues of Greffex, Inc.
For the last four weeks we have been fielding questions regarding Ebola and the state of Ebola vaccines. Those who follow us know that we are advancing into the clinic with our H5N1 (Avian Flu) vaccine and that we have developed a MERS Co-V vaccine, both based on our proprietary technology, as well as vaccine candidates for a host of other potential threats.
In May, 2013, we released a report on our H7N9 Avian Flu vaccine candidate. In it we stated: “We believe the world needs a ‘plug-and-play'(TM) (universal interchangeable platform) method of creating vaccines.” 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.” We created a H7N9 Avian Flu vaccine from a dead stop to prove it could be done if an emerging threat occurred.
In June, 2013, we released information regarding our MERS Co-V vaccine. “Greffex unrivalled production times resulted from its proprietary and patented GREVAX(TM) 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, GREVAX(TM) vaccines are designed as small synthetic nanoparticles of genes packaged in an adenoviral shell 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. We have a clean product that does not expose you to contaminations…”
Now Ebola is ravaging Africa, and has raised its ugly head in Europe, the United States and Canada. Health agencies are scrambling to find a vaccine solution. Millions of dollars have been thrown at systems to develop a vaccine candidate; some will prove moderately successful as short-term solutions. We believe these solutions will prove inadequate to stem the tide AND to create a platform from which other vaccine candidates can be made should a new strain of Ebola or other threats appear. Buried in the messages from health agencies is the fact that there is a great need for a trivalent vaccine that carries sequences for both Ebola strains plus the Marburg virus. All vaccines presented as solutions only address a single Ebola strain (sequence) while some include Marburg. Further, no mention of time of production and more importantly cost of production has been made. Developers offering a limited vaccine candidate for Ebola within a period of time without them addressing their clinical trial problems (at this writing the WHO and other health agencies have not addressed the social, ethical and systemic problems of human clinical trials, particularly Phase III human trials) and the burdensome costs and extraordinary length of time associated with their production is simply irresponsible. It is also important to understand that scientists differ on many issues with some vaccines being developed. In our White Paper we note that one current VSV Ebola vaccine being developed has two significant issues. The first is that because it is a “replication efficient” VSV, that is an infectious virus, it may cause serious side effects. There may be a better VSV Ebola virus vaccine candidate but it has not been tested. With regard to the current VSV Ebola vaccine candidate, Greffex believes there is potential for deleterious effects if given to undeveloped world populations that have shaky immune systems due to food deprivation and pre existing diseases such AIDS, tuberculosis, and malaria. The second problem is that the above-mentioned vaccine is based on an old Ebola sequence, not the sequence of the current Ebola infection. Greffex believes that this is significant because these changes (mutations) lie in a crucial area of the vaccine antigen. Some scientists incorrectly believe that they are not important because they are “only” between 2% and 7%. We believe that the VSV Ebola vaccine being presented does not address the “mutation actuality” that the immune system sees. Basically, the antibodies made against the old Ebola antigen may not be fully protective against the new one. In our White Paper we address these issues in specificity. I touch on them here to remind us all that science and solutions change rapidly.
WE INVITE YOU TO READ OUR WHITE PAPER. IT COMPARES THE MAJOR PRESENTED VACCINE SOLUTIONS. IT GENERALLY DESCRIBES OUR PROPRIETARY SYSTEM.
We invite comments, challenges and questions.
In non-scientific terms we at Greffex state:
- Greffex is the only company that can make a trivalent Ebola-Marburg vaccine in a single vector based on its fully deleted Ad platform,
- The Greffex vector will be packaged into capsids of the Adenovirus serotype 2, as well as 5, (this scientific statement tells readers that Greffex builds a vaccine on multiple serotypes-blood types).
- The Greffex Ebola vaccine will be administered intranasally,
- The Greffex Ebola vaccine by design allows prime boost immunization regimens with the same vaccine construct, if required,
- The Greffex vaccine can be delivered to ANY AGENCY within 4 weeks from start date,
- Greffex production scheme allows the company to make 10,000 (ten thousand) doses of its Ebola candidate in house under GMP conditions for testing within a month,
- Upon completion of all testing, Greffex believes it can deliver the required number of trivalent Ebola vaccine doses within the requested time period.
A vaccine solution for Ebola that delivers exactly what is needed quickly IS available. Greffex offered two additional components to its vaccine solution.
- Greffex can deliver a testable Ebola vaccine candidate in one month from start date.
- Greffex will forgo all profits from the sale and distribution of a Greffex Ebola Vaccine to African countries in need.
Why would a small, often struggling Biotechnology Company give away its vaccine solution to Africa? It is because those of us lucky enough to get up in the morning thinking that we probably won’t get Ebola need to be part of the world health solution for those that are not that fortunate. Dr. Paul Farmer, cofounder of Partners in Health writes that the “growing inequality in global healthcare is at the root of the Ebola Crisis.” Dr. Farmer cannot do what we, a commercial company can: challenge itself and others to reverse the challenges of “poverty diseases.” It is the right thing to do for Africa. Greffex faces many nonscientific hurdles in its journey to make its Ebola vaccine. Developing an Ebola vaccine by Greffex is inexpensive. Later testing is costly. But Greffex can, right now, start the conversation amongst pharmaceutical manufacturers and vaccine developers to forgo profits from Ebola vaccines for use in Africa!
Finally, one thing has remained constant. Since the Swine Flu epidemic of the 1970’s, the United States has not developed an interchangeable vaccine platform to address these ever changing and mutating diseases: one that is nimble and cost effective. Greffex has that solution. And Greffex believes that nature is presenting us with challenges we must be equipped to overcome, because every wild spreading disease is simply a test bed for the next one.
On a personal note, I am extremely grateful to our board of directors, my business partner, Dr. Uwe Staerz, my Executive Vice President Bill Connolly and all the dedicated scientists and administrators at Greffex for developing great science and for supporting the decision to give away all profits from Ebola vaccines for use in Africa. Everything I learned can be summed up in this simple verse to which all at Greffex adhere: “unto him to whom much is given, much is required.”
In the coming weeks we will post questions we receive and our responses here on our website.
John R. Price
President and Chief Executive Officer
NIAID TESTS GREFFEX’S EBOLA VACCINE
February 1, 2015
A 1967 outbreak of the “Marburg” virus (MARV) first brought to light the dangers of viral hemorrhagic fevers caused by viruses of the filoviridae family. After an outbreak in 2012 a death from a MARV infection was recently noted in Uganda. Other members of the filovirus family, namely the Ebola viruses (EBOV), are even more lethal. The members of this genus are named after the location of their major outbreaks, Zaire (ZEBOV), Sudan (SEBOV), Reston, VA (RESTOV) and Cote d’Ivoire (CIEBOV). Numerous outbreaks of viruses have been observed in the last 40 years (WHO). The most devastating outbreak so far was caused by a mutated version of ZEBOV. It first appeared in December 2013 and has spread through several countries in Western Africa, Guinea, Sierra Leone, and Liberia. It has been spreading in an uncontrolled fashion and has led to several thousand infections and deaths (WHO). Travelers infected with the disease have reached Europe and the US leading to secondary transfers of the disease to nurses in Spain and the US (WHO). Neither therapeutic drugs nor vaccines are presently available to combat any of these infections.
In November 2014, Greffex initiated discussions with the National Institute of Allergy and Infectious Diseases (NIAID) about the construction of a GreVAX-based Ebola vaccine. Due to the earlier success with GreMERSfl and GreFluVie, Greffex was invited by NIAID to deliver an Ebola vaccine candidate to be tested in nonhuman primates. Greffex initiated the construction of its GreZEBm vaccine candidate. It was completed within one month. In parallel, the Company’s scientists developed a stringent testing protocol that took into consideration the medical realities found in Western Africa. Their goal was closely to approximate future clinical trials. In early February 2015, Greffex delivered its GreVAX-based GreZEBm vaccine to NIAID for these protective studies in NHPs.