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PaxVax Partners with National Institutes of Health and Department of Defense to Develop a New Virus-Like Particle Vaccine to Fight the Spread of Chikungunya

REDWOOD CITY, CA – January 5, 2017 – PaxVax announced today its partnership with the National Institutes of Health (NIH) and United States Department of Defense (DoD) on its chikungunya vaccine program. According to the terms of the collaboration, PaxVax has in-licensed the NIH virus-like particle (VLP) vaccine technology for chikungunya with plans to bring the vaccine through full commercialization. NIH has already completed a phase 1 trial, and is currently assessing the vaccine in a phase 2 trial.

PaxVax to Receive California Life Sciences Association’s 2016 Rising Star Award

REDWOOD CITY, CA – October 11, 2016 – PaxVax, Inc., a fully integrated specialty vaccine company committed to developing and commercializing innovative vaccines against infectious diseases, today announced that it has been selected to receive the 2016 DiNA™ Rising Star Award from the California Life Sciences Association (CLSA) at its annual Pantheon Awards Ceremony, which honors innovation and excellence within California’s life sciences sector.

In the News

USAMMDA - 02/27/2017
Since October 2011, the U.S. Army Medical Materiel Development Activity's Pharmaceutical Systems Project Management Office has been managing the supply of Adenovirus Vaccine Types 4 and 7 for administration to U.S. Service Members during basic training. The vaccine has been highly effective and has helped to greatly reduce respiratory illness in these environments, keeping our trainees healthy during basic training. Dr. Clifford Snyder, Adenovirus Vaccine product manager, has been leading the Adenovirus Vaccine team since March 2011, and it is his job to ensure availability of the vaccine into the future. In light of this, Snyder's team has been involved in efforts to develop a new version of the vaccine, known as Modernized Production Adenovirus Vaccine, for which an Investigational New Drug application for MPAV Prototype A was submitted to the U.S. Food and Drug Administration Jan. 30. "Our current vaccine has been in use for over five years, and it is a great product," said Snyder. "It's given to more than 200,000 enlisted military trainees each year, throughout all Service branches, and it is very safe and efficacious. "However, as product manager, my job also entails identifying a possible follow-on product to ensure availability of the vaccine for our troops is not interrupted, in the event of any unforeseen situation with our current supplier, Barr Laboratories, Inc. [a division of Teva Pharmaceuticals]." To shed light upon the recent pursuit of new methods of production, Snyder offered a brief history of the current vaccine and the impact of febrile respiratory disease on military readiness in World War II. With the draft policy in place to support wartime efforts, "boot camps" across the country witnessed an influx of trainees, with groups arriving and deploying on a frequent basis. Due to the large number of Service Members brought together in close quarters, febrile respiratory illness – specifically, cases caused by Adenovirus Types 4 and 7– emerged among trainees, affecting large populations at the same time. To combat this threat, a vaccine was developed and tested in the 1960's and then routinely administered to prevent febrile respiratory illness among trainees. Widely used between 1971 and the late 1990's and manufactured by Wyeth Laboratories, Inc., this vaccine was so effective that the threat of illness soon became a memory. In light of this, the funds necessary to maintain the production facility at Wyeth were not made available. As febrile respiratory illness returned to basic training sites soon after Adenovirus Vaccine supplies were exhausted in 1999, senior officials in the Department of Defense requested restoration of vaccine capability and assigned this mission to the U.S. Army Medical Research and Materiel Command, USAMMDA's Higher Headquarters. Restoration of Adenovirus Vaccine production capability, which culminated in FDA approval, took nearly a decade; it has been highly effective since administration began in October 2011. "When the illness resurfaced after 1999, there was an urgency to remanufacture the vaccine, and the USAMRMC was handed the task of bringing it back as quickly as possible for our Service Members," said Snyder. However, in working quickly to restore the manufacturing capability once again, Snyder said that the government directed its pharmaceutical contractor to use the same methods and manufacturing practices from the original 1960's version – which was already proven safe and effective – to re-create the same vaccine. The government provided Wyeth's instructions for product manufacturing, which was done in a very controlled, reproducible manner. This was the beginning of a 10-year development effort, including clinical studies in recruit populations, which fortunately had a very successful outcome for our military troops in training camps across the country. Fast forward to present day, and while the current Adenovirus Vaccine continues to shield our military trainees against febrile respiratory illness, the process of developing new manufacturing methods to address certain risks is ongoing. As Snyder explains, "There are a number of factors, both business and technical, which have prompted us to seek a new vaccine for Adenovirus, and in doing so we have initiated some interesting partnerships with great potential for advancement of this vaccine, and possibly other pharmaceutical products, as we move forward." Snyder's dedication to this important effort is very clear, and he detailed the reasons for USAMMDA's present focus on the MPAV program. "Although we're in the middle of a five-year delivery contract with Barr, the current supplier of the vaccine, it's our job to mitigate possible risk factors, and that's exactly what we're doing," he said. "In conjunction with the Small Business Innovation Research program, we solicited proposals from numerous companies, and after various levels of review, PaxVax, Inc. was selected as our contractor for development of MPAV and also serves as Regulatory Sponsor," continued Snyder. "Col. Robert Kuschner of Walter Reed Army Institute of Research has been very instrumental in his role as SBIR topic author, contracting officer's representative for several SBIR contracts, and as Independent Research Monitor for the upcoming Phase 1 study. In addition, WRAIR will play a role in performance of immunological assays." Snyder hopes that by utilizing the SBIR program in this development effort, his team will be able to determine if PaxVax, a small business, can develop and manufacture a vaccine that is equally as safe and effective as the current one, and if this innovation can result in overall cost savings and risk reduction. Much of this "innovation" lies in the actual manufacturing of the vaccine, which currently is being produced using the same technology from the 1960's, albeit successfully. By incorporating state-of-the-art processes into production, Snyder believes this switch should help lower the per-dose cost, which is now approximately $150. PaxVax was ultimately chosen as SBIR contractor because of its prior experience in working with multiple strains of Adenovirus. Among the potential risks that prompted USAMMDA to begin its search for a new Adenovirus Vaccine product is the fact that the current manufacturer could stop production at any time, after the end of its current delivery contract. Also, the essential biological materials of the present vaccine, the Type 4 and Type 7 Adenoviruses, are produced overseas in Scotland, and Snyder's team would like to bring this process to the U.S. going forward. PaxVax intends to produce these critical materials in its home state of California. Another interesting aspect of the new development process being established by PaxVax is the method of removing water from virus preparations. Currently, water is removed by the process of lyophilization, which involves exposure of frozen viruses to a lengthy set of combinations of temperature and reduced pressure. MPAV Prototype A is being manufactured using this method, whereas MPAV Prototype B, which is in early process development, will use a spray drying method to remove water. Spray drying is more rapid than lyophilization and can produce a free-flowing powder, which lyophilization does not. However, only actual experience in manufacturing and testing will reveal the pros and cons of spray drying as applied to Adenovirus Types 4 and 7. The current form of Adenovirus Vaccine is given in two tablets, one for Type 4 and one for Type 7. These tablets are made by compressing viruses and inactive ingredients to form an inner core, and then performing a second compression with additional inactive ingredients to protect the core against the organic solvents that are used to deliver an enteric coating to the tablets. This enteric coating protects the viruses from stomach acid but allows the tablet to dissolve once it encounters the small intestine. Needless to say, the two-step tableting process is extremely critical, as well as costly, and PaxVax is working to develop a way of delivering the Type 4 and 7 Adenoviruses in a capsule instead of a tablet. While MPAV Prototype A will consist of two capsules, MPAV Prototype B will combine both Type 4 and Type 7 in one capsule, which actually provides another engineering challenge – but again, Prototype B is presently in the early stages of process development. Said Snyder, "Of course, one capsule will be much easier to distribute and ingest than two tablets, but we still have a way to go before we reach that point, although we're quite hopeful." Snyder acknowledged and praised the U.S. Army Medical Research Acquisition Activity, which has been handling the multiple contracts put in place in support of this effort. He went on to explain that although the SBIR program is helping to fund development of this vaccine, the Prototype B vaccine is receiving financial support from the U.S. Army's Manufacturing Technology Program, also known as ManTech. "ManTech is providing $5 million in funding for the early development of MPAV Prototype B," he said. "Without this support, we might not have Prototype B, which is actually very interesting and may eventually offer the greatest potential for production cost savings [due to spray drying and single-capsule form]." Although MPAV Prototype A is ready to be tested in a Phase 1 clinical study, Snyder believes that Prototype B will be ready for clinical study in early 2018, after PaxVax has finished development of the spray-drying process. "Both prototypes will hopefully be tested before Milestone B," he said, "and we could have the clinical study results for both Prototypes A and B by late 2018. At that time, PaxVax should have more manufacturing data, on a small scale, in order to make cost projections for [DOD] decision making. Then, we could move into scale-up and Phase III studies." If this process goes smoothly, and if funding permits, Snyder believes the MPAV product could be ready for FDA licensing by 2021, and available for distribution to military trainees in 2022. He also noted that the availability of funding from the Defense Production Act Title III program would help maintain an aggressive development schedule. "The execution of DPA Title III funding requires Presidential approval, and with the recent change in administration, we hope this does not slow down the approval process," said Snyder. Considering all that is going into the manufacturing of the Adenovirus Vaccine by both the current and potential supplier working with this crucial product, one thing certainly remains clear: the safety of our Warfighters throughout all military branches is the primary focus of this important effort. In the same vein, the work being conducted by Snyder and his team at USAMMDA's PSPMO, and members of the Integrated Product Team beyond the PSPMO, highlights the tremendous commitment of the men and women of an organization dedicated to developing and delivering quality medical capabilities to protect, treat and sustain the health of Service Members worldwide. In light of this, USAMMDA remains the premier developer of world-class military medical capabilities and will continue its mission to provide critical products, drugs and devices that help bolster our nation's military forces.
The Hill - 10/31/2016
Two years ago, Americans and Europeans watched in collective horror as a faceless, indiscriminate killer landed in their midst without warning. Fear and widespread anxiety were joined by deep frustration at the apparent unpreparedness to handle a threat of such magnitude. I’m not referring to a terror attack or a natural disaster. And though the killer was faceless, it had a name – Ebola. Of course, the people of Africa were quite familiar with Ebola hemorrhagic fever. National governments,  international organizations, humanitarian aid agencies, including Doctors Without Borders and the International Rescue Committee, and health officials in Guinea, Sierra Leone, Liberia and other affected nations have worked tirelessly to contain the disease, which killed 11,300 people in the region during the 2014 outbreak. It wasn’t until the first cases were diagnosed in the U.S. and Western Europe that developed countries realized the scourge was no longer confined to developing countries. Thankfully, as so often happens in a global health crisis, leaders in public health and government joined forces to develop the protocols needed to stabilize the outbreak. Today, the Zika virus represents a new, potentially devastating pandemic throughout Latin America and the southern U.S. (for now). Fortunately, we’ve had warning to prepare for Zika. Unfortunately, the U.S. is still unprepared to effectively fight it. Centers for Disease Control and Prevention (CDC) Director Tom Frieden told reporters in September that “we are now essentially out of money” and informed policy makers that the U.S. is “about to see a bunch of kids born with microcephaly,” a condition in which babies are born with abnormally small heads and brain defects. Microcephaly is just one of the potentially long-term consequences that may affect babies born with Zika. Frieden’s remarks came as Congress struggled to reach an agreement on a bill proposing more than $1 billion for studies, diagnostic tests, vaccine and drug research and programs to battle Zika. So far in the U.S. more than 730 pregnant women have been found to carry the virus and at least 18 babies have been born with microcephaly. Nearly 3,000 people in the continental U.S. have been infected; the numbers in Puerto Rico and other U.S. territories, and many countries in Latin America, are considerably higher. While the Obama Administration has redirected funding from other health priorities as a temporary measure, and it’s not clear whether any work on a vaccine has been delayed, what we do know is that without a plan and resources, the numbers will only continue to grow across the country and around the world.  The response to Ebola and the current stalemate in Congress over Zika funding help illustrate how critical global-scale planning, collaboration and funding are to preventing epidemics. And they point to the increasingly important role that organizations like the Coalition for Epidemic Preparedness Innovations (CEPI) can play. CEPI is a new public-private alliance dedicated to rapidly creating an arsenal of new vaccines to prevent and contain infectious global health epidemics. The concept is to invest in early development of vaccines in order to dramatically reduce the time it takes to have them ready and prepared before an outbreak occurs. The Norway-based coalition is spearheaded by the Wellcome Trust, the Bill and Melinda Gates Foundation, the World Economic Forum and the governments of Norway and India. CEPI will initially focus on vaccines to treat diseases identified by the World Health Organization as priority public health threats. Some of the diseases CEPI is considering to target include Lassa fever, Marburg fever, MERS, SARS, Nipah virus, Rift Valley fever, chikungunya and other emerging diseases for which there are currently no vaccines. By funding the early stages of research and development, CEPI can help bring many vaccine candidates forward for a variety of diseases. This way, instead of predicting what the next epidemic will be, we will be ready for whichever one actually breaks out and can then move to late stage clinical studies and quickly get a product approved. Despite scientific advancements that have brought us safe and effective treatments for a host of cancers, neurological disorders and other difficult to treat diseases, it seems inconceivable that there are still dangerous infectious diseases for which there are no licensed vaccines. In part, this is due to the long and arduous process of vaccine development. Pre-clinical and clinical development of a vaccine typically takes 12 to 15 years and requires assessment of the safety and efficacy of the vaccine on thousands of patients. There are unpredictable commercial incentives and pathways to regulatory approval as well. And the rarity and remote location of certain outbreaks also makes it difficult for scientists to study a disease or find enough patients to conduct effective vaccine trials. These and other factors all have the potential to deter investment, even for firms that are committed to discovering new medicines for the good of all who need them. With that said, it’s not difficult to recognize that there is a misalignment between how industry works to develop vaccines and what public health needs are. The solution to this dilemma begins with collaboration.  We’ve seen that when working alone, industry players face barriers to vaccine development. Ebola and Zika have taught us that devastating epidemics aren’t just a threat to those in far off lands. It’s time to turn those lessons into action, and find innovative ways to be prepared before outbreaks become pandemics. Nima Farzan is Chief Executive Officer of PaxVax, Inc. and the Biotechnology Innovation Organization (BIO) delegate on the board of the Coalition for Epidemic Preparedness Innovations.    
Associated Press - 06/10/2016
WASHINGTON — Federal health officials have approved the first cholera vaccine intended to protect U.S. travelers from the potentially life-threatening disease. The Food and Drug Administration approved the liquid vaccine, called Vaxchora, for adults ages 18 to 64 who are traveling to countries affected by cholera.