The latest edition of the Argon CBRNe and HazMat Training Insights newsletter has been released. In this issue: training for CBRNe & HazMat incidents at mass public events; improving initial operational response to CBRNe incidents; 8 simple scenarios to obtain maximum benefit from your HazMat training and what makes a chemical toxic?
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GeoVax Labs, Inc.has announced positive results (100% protection) from preclinical challenge studies of its Marburg virus vaccine candidate; Marburg virus a critical medical threat against which there is currently no available vaccine or treatment. This study data adds to that showing similar efficacy previously reported for GeoVax’s Ebola and Lassa Fever vaccines
In this study, GeoVax’s Marburg vaccine (GEO-EM05) was administered by intramuscular (IM) inoculations to guinea pigs, with a control group receiving saline injections. Eight weeks after inoculation, animals in each group were exposed to a lethal dose of Marburg virus (MARV). Within 8 days post-challenge, all animals in the control group had developed moribund conditions and had to be euthanized. At the conclusion of the study (21 days post-challenge), all vaccinated animals survived, with no weight loss or other health issues. The study was conducted in collaboration with researchers at the University of Texas Medical Branch at Galveston (UTMB).
GEO-EM05 is based on the Company’s novel Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform, which generates noninfectious VLPs in the individual being vaccinated. VLPs mimic a natural infection, triggering the body to produce a robust and durable immune response with both antibodies and T cells.
Farshad Guirakhoo, Ph.D., GeoVax’s Chief Scientific Officer, commented, “We are highly encouraged by the results of this study, particularly as it adds to the excellent results observed in studies for our vaccines against Ebola and Lassa, two other hemorrhagic fever viruses highly lethal to humans. There is a significant need for safe, effective vaccines against the various hemorrhagic fever viruses, and we are committed to advancing preventive vaccines against these infectious disease threats to world health.”
Alexander Bukreyev, Ph.D., Professor, Departments of Pathology and Microbiology & Immunology, Galveston National Laboratory at UTMB, commented, “We are very pleased to see the MVA-VLP-MARV vaccine (GEO-EM05) conferred full protection in our guinea pig lethal challenge model.”
Battelle has won an Associated Contractor Agreement for a new Defense Advanced Research Projects Agency (DARPA) Epigenetic Characterization and Observation (ECHO) program. The aim is to build a field-deployable platform technology that quickly reads someone’s epigenome and identifies signatures that indicate whether that person has ever—in his or her lifetime—been exposed to materials that could be associated with weapons of mass destruction (WMD).
Battelle will examine blood samples from people known to have handled materials associated with biological, chemical, explosive, pesticide or herbicide contaminants and compare those results to control subjects who have not handled these materials to identify unique epigenome signatures.
The epigenome is biology’s record keeper. Though DNA does not change over a single lifetime, a person’s environment may leave marks on the DNA that modify how that individual’s genes are expressed. This is one way that people can adapt and survive in changing conditions, and the epigenome is the combination of all these modifications. Though modifications can register within seconds to minutes, they imprint the epigenome for decades, leaving a time-stamped biography of an individual’s exposures.
Whereas current forensic and diagnostic screening technologies only detect the immediate presence of contaminants, the envisioned ECHO technology would read someone’s epigenome from a biological sample even when other physical evidence has been erased.
“We’ll be developing methods to identify these signatures and how to interpret them for attribution—what did the person handle, when and for how long,” said Battelle Biologist and Principal Research Scientist Rachel Spurbeck, PhD, who is leading the effort. “This will even allow for diagnosing illnesses in individuals as a result of their exposure.”
Patents cover SGX201 in acute radiation enteritis and OrbeShield® for acute total body irradiation.
Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the European Patent Office has issued two patents, both titled "Topically Active Steroids for use in Radiation and Chemotherapeutics Injury". The new patents (#2,373,160 and #2,902,031) claim use of oral beclomethasone 17,21-dipropionate (BDP) for treatment of damage to the gastrointestinal (GI) tract as a result of acute radiation injury, including total body irradiation in an accidental or biodefense context.
About SGX201 and OrbeShield
SGX201 is formulated for oral administration in cancer patients as a single product consisting of a delayed release (enteric coated) tablet which releases BDP in the distal portions of the GI tract. SGX201 has been awarded fast-track designation from the FDA for the prevention of radiation enteritis. Previous studies with SGX201 have been supported by a National Cancer Institute Small Business Innovation Research (SBIR) grant #R43CA141968.
OrbeShield is formulated for oral administration in gastrointestinal acute radiation syndrome (GI ARS) patients as a single product consisting of two tablets. One tablet releases BDP in the proximal portions of the GI tract, and the other tablet releases BDP in the distal portions of the GI tract. OrbeShield has also been granted Orphan Drug and Fast Track designations by the FDA for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster. OrbeShield development as a medical countermeasure for GI ARS has been supported by the Biomedical Advanced Research and Development Authority (BARDA) (contract #HHSO100201300023C) and the National Institute of Allergy and Infectious Diseases (NIAID) (contract #HHSN27220130030C) contracts.
Myelo Therapeutics GmbH, an Affiliate of Eckert & Ziegler Strahlen- und Medizintechnik AG, has announced that the European Medicines Agency (EMA) has granted an Orphan Drug Designation to its orally applied new chemical entity Myelo001 (Imidazolyl ethanamide pentandioic acid) for the treatment of Acute Radiation Syndrome (ARS).
This successful ruling from the EMA follows on from the 2018 ruling by the Federal Drug Administration to award an Orphan Drug Designation (ODD) to Myelo001 for the treatment of ARS. An Orphan Drug Designation is a status assigned to medicines developed for rare conditions. ODD's are grounded on proven medical plausibility of the orphan condition, and potentially significant benefits of the proposed treatment.
ARS, also known as radiation toxicity or radiation sickness, is an acute illness that presents after exposure to high levels of radiation, caused by a nuclear accident or attack. It can lead to severe health consequences, including death. The European Union (EU) and the US government, amongst other countries, are encouraging the development of new drugs to prevent or treat ARS.
Myelo001 is a new, clinical-stage adjuvant cancer therapy for the treatment of chemotherapy- and radiotherapy-induced myelosuppression. Preclinical and clinical studies have shown that Myelo001 applied orally is effective in reducing hematopoietic symptoms caused by chemotherapy and radiation. Comprehensive chronic toxicology and safety studies, as well as clinical studies, have confirmed an excellent safety profile of Myelo001.
The EU orphan designation program provides incentives to companies that are developing therapies for diseases which affect fewer than 5 in 10,000 people within the territory of the EU. The benefits of achieving Orphan Drug Designation include scientific advice by EMA on study protocols, regulatory fee reductions and waivers, as well as access to EU grants for drug development. Upon marketing approval, Myelo001 will benefit from 10 years of market exclusivity for the ARS indication within the EU’s territory.
Therapies for ARS qualify as medical countermeasures (MCMs), which may be used in the event of a potential public health emergency caused by a biological, chemical, or radiological/nuclear material. MCMs are purchased and stockpiled by the EU through its Joint Procurement Agreement for MCMs, the US Department of Health and Human Services and US Department of Defense, as well as various other foreign governments and militaries
New tools for programmable modulation of gene expression could yield enhanced resilience against influenza and ionizing radiation for service members and first responders.
Breakthroughs in the science of programmable gene expression inspired DARPA to establish the PReemptive Expression of Protective Alleles and Response Elements (PREPARE) program with the goal of delivering powerful new defenses against public health and national security threats. DARPA has now selected five teams to develop a range of new medical interventions that temporarily and reversibly modulate the expression of protective genes to guard against acute threats from influenza and ionizing radiation, which could be encountered naturally, occupationally, or through a national security event.
The program builds from the understanding that the human body has innate defenses against many types of health threats, but that the body does not always activate these defenses quickly or robustly enough to block the worst damage. To augment existing physiological responses, PREPARE technologies would provide a programmable capability to up- or down-regulate gene expression on demand, providing timely, scalable defenses that are proportional to anticipated threats. Service members and first responders could administer these interventions prior to threat exposure or therapeutically after exposure to mitigate the risk of harm or death.
“Researchers working within the PREPARE program seek to improve rates of survival and recovery in catastrophic scenarios for which reliable and scalable countermeasures don’t currently exist,” said Dr. Renee Wegrzyn, the PREPARE program manager.
For example, influenza persists as a perennial health threat despite the development of vaccines that help protect against predicted strains of circulating virus. The annual challenge of developing a new vaccine and the burdensome logistics of storing, transporting, and distributing injectable vaccines make alternative protective strategies desirable.
Three PREPARE teams are pursuing multi-pronged approaches to influenza defense and treatment that use programmable gene modulators to boost the human body’s natural defenses against influenza and also weaken the virus’ ability to cause harm by directly neutralizing the viral genomes. If successful, their approaches would potentially protect against virtually all influenza strains — regardless of whether a virus is newly emergent or has developed drug resistance — and would provide near instantaneous immunity, in contrast to traditional vaccines. Additionally, the teams are designing their countermeasures so that they are simple to deliver — for example, as intranasal sprays — reducing the logistical challenge of protecting large numbers of people.
Other PREPARE teams are pursuing treatments to protect the body from the effects of ionizing gamma radiation. In humans, radiation poisoning primarily affects stem cells in the blood and gut, yet existing treatments only help to regenerate blood cells, and only with limited effect. There is no possibility for prophylactic administration of these drugs, and most must be delivered immediately following radiation exposure to provide any benefit. There are no existing medical countermeasures for radiation damage to the gut.
The following two teams are working to generate programmable gene modulators that can protect the blood or gut, with the possibility of prophylactic administration of interventions to service members and first responders going into environments where the risk of radiation exposure is high.
All of the teams are working toward an end goal of submitting at least one product to the U.S. Food and Drug Administration (FDA) for regulatory review as an Investigational New Drug by the end of the program period. DARPA requires teams to work closely with the FDA throughout the four-year program to ensure data generated and experimental protocols meet regulatory standards. The research will similarly benefit from insights garnered through regular engagement with bioethicists.
One such insight — that permanent edits to the genome are neither desirable nor ethically justifiable in otherwise healthy populations — informed DARPA’s decision to mandate that PREPARE technologies have only temporary and reversible effects and do not alter host primary DNA sequences in any way. Teams will achieve this by interfacing only with the epigenome and transcriptome, the cellular messages that carry out DNA’s genetic instructions inside cells.
“PREPARE reflects DARPA’s ‘safety first’ approach to genome editing,” Wegrzyn said. “We’re developing tools that deliver the health and safety benefits of modulating genetic expression without the risks of permanent edits to the genome and the potential off-target effects they entail.”
The FULL programme for CBRNe Convergence 2019 is NOW AVAILABLE.
Head over to the event page and check out all of the amazing speakers and exhibitors we have joining us in Nashville, Tennessee, this year!
SIGA Technologies, Inc., a commercial-stage pharmaceutical company focused on the health security market, today announced that it has entered into an international promotion agreement with Meridian Medical Technologies, Inc. Under the agreement, Meridian will promote the sale of oral TPOXX for the treatment of smallpox in all markets, except for the United States and South Korea. SIGA will continue to be the owner of all rights in the U.S. market.
“Meridian, a leader within the global medical countermeasure industry, has sold products in over 30 countries worldwide and has been marketing and distributing emergency care treatment options to military and civilian authorities for more than 50 years. We are pleased that they recognize TPOXX’s significant market potential outside the U.S.,” said Dr. Phil Gomez, CEO of SIGA. “We are confident that Meridian’s experience and broad network in these markets makes it an optimal partner for SIGA as we work to make oral TPOXX a standard component of smallpox preparedness strategies around the globe.”
Under the terms of the agreement, Meridian has exclusive rights and responsibilities to market and sell oral TPOXX in all geographic regions except for the U.S. and South Korea, and SIGA retains ownership, distribution and supply rights and regulatory responsibilities in connection with TPOXX. The agreement does not include any cash payments at signing, and both parties are responsible for the costs of their respective activities. Meridian will be compensated under the promotion agreement through a fee that will be based on a percentage of net sales of oral TPOXX.
“TPOXX is a natural addition to Meridian’s portfolio of medical countermeasures and emergency care treatments,” said Tom Handel, General Manager for Pfizer and President of Meridian. “We are excited to partner with SIGA to leverage our collective strengths for the ultimate benefit of global health security, the patients and customers who we serve.”
TPOXX is the first and only drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of smallpox disease in adults and pediatric patients weighing at least 13 kg (~29lbs). Over 2 million courses of TPOXX have been stockpiled by the U.S. Government to mitigate the potential impact of a smallpox outbreak. The World Economic Forum report titled “The Global Risks Report 2019” highlighted that recent developments have “increased the risk of smallpox being released into the world, either accidentally or intentionally.” Given the highly infectious nature of smallpox, any outbreak could rapidly become a global emergency, and medical countermeasures will need to be deployed rapidly by all impacted nations.
Zhilong Yang, an assistant professor in the Division of Biology, is the principal investigator on a new, nearly $1.9 million grant from the National Institutes of Health. The five-year project will study how vaccinia virus — a member of the poxvirus family — produces its proteins. This award is from the Research Project Grant Program, usually referred to as R01, and is considered the bread and butter grant of the NIH for biomedical researchers.
The NIH has continuously supported Yang's research on vaccinia virus through multiple awards in the past five years, when he opened his laboratory at K-State, including a Pathway to Independence award, an Exploratory/Developmental grant award and a Centers for Biomedical Research Excellence project, in addition to the R01 award. Yang's group has made a series of remarkable discoveries on this topic.
Vaccinia virus was used as the vaccine to eradicate smallpox, one of the deadliest infectious diseases in human history. Both vaccinia virus and variola virus, the latter is the causative agent of smallpox, belong to a large family of virus called poxvirus. Although smallpox was eradicated 40 years ago, many members of poxviruses currently cause significant public health issues in humans and economically important animals. There is also a concern that smallpox may arise from unknown stocks or other means.
But poxviruses do not always cause harm. In fact, many poxviruses, including the vaccinia virus that Yang is studying, can be used to fight other human and animal diseases. For example, vaccinia virus can serve as a carrier for developing vaccines to fight many other human and animal infectious diseases. A number of currently used veterinary vaccines are generated based on vaccinia virus.
Vaccinia virus, along with many other poxviruses, also has tremendous potential in fighting cancers, because it can selectively kill tumor cells. By engineering the virus to be less harmful to healthy tissues but to kill tumors more efficiently, scientists are developing highly promising new cancer therapeutics.
This grant will help Yang and his colleagues in his laboratory to answer a fundamental question: How does vaccinia virus produce viral proteins? This is an important question to understand how the virus amplifies itself, as proteins are building blocks to make viral particles. Interestingly, viruses do not have the machinery to make proteins by themselves. Instead, they must use their hosts' protein-making machinery. This makes the question even more intriguing: how does the virus redirect the host protein-making machinery to produce viral proteins after infection?
Answers to this fundamental question could provide new strategies to block poxvirus infection and improve the efficacy of poxviruses used in vaccine development and cancer therapy.
Valneva SE (“Valneva”), a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, and the Coalition for Epidemic Preparedness Innovations (CEPI) hereby announce a new partnering agreement.
With support from the European Union’s (EU’s) Horizon 2020 programme, CEPI will provide Valneva up to US$23.4 million for vaccine manufacturing and late-stage clinical development of a single-dose, live-attenuated vaccine (VLA1553) against Chikungunya. In line with CEPI’s commitment to equitable access, the funding will underwrite a partnership effort to accelerate regulatory approval of Valneva’s single-dose Chikungunya vaccine for use in regions where outbreaks occur and support WHO prequalification to facilitate broader access in lower and middle-income countries.
Valneva will also maintain a stockpile of the vaccine candidate and work to transfer the secondary manufacturing of the drug product to partners for lower and middle-income countries—where outbreaks of Chikungunya have occurred—to improve access to the vaccine for at-risk populations.
The investment is part of CEPI’s third call for proposals, launched earlier this year with support from the EU’s Horizon 2020 research and innovation programme under grant agreement No. 857934.1 Since the launch of this call in January 2019, over US$66 million has been invested in two Chikungunya vaccine candidates and two RVF vaccine candidates.
Chikungunya virus was first identified in Tanzania in 1952, with sporadic outbreaks of the disease reported subsequently across Africa and Asia. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, the total number of cases has been estimated at over 3.4 million in 43 countries.4 As such, the World Health Organization (WHO) has highlighted Chikungunya as a major public health risk.5
Chikungunya is spread by the bites of infected female Aedes mosquitoes and causes fever, severe joint pain, muscle pain, headache, nausea, fatigue, and rash. Joint pain is often debilitating and can persist for weeks to years.6
Climate change could further amplify the threat posed by Chikungunya. As the climate warms, more areas across the world will become habitable for the mosquito vectors that transmit the virus, thereby increasing the size of the human population at risk of infection. For example, in 2007, an outbreak of Chikungunya virus infections was declared for the first time in Europe with more than 200 human cases reported in Italy.7 Since 2014, in the USA, local-transmission of the virus has been reported in Florida, Puerto Rico, and the U.S. Virgin Islands.8
Dr Richard Hatchett, CEO of CEPI said:
“Millions of people have been affected by Chikungunya and, today, over a billion people live in areas where Chikungunya outbreaks occur. Despite the large outbreaks and significant consequences of this disease, there is currently no specific antiviral drug treatment nor are any vaccines licenced for human use against this virus. Through our partnership with Valneva, we hope to speed up the development of a Chikungunya vaccine, ensure that the people most affected by this virus can benefit from this product, and by doing so help to alleviate the burden of this debilitating disease. ”
Thomas Lingelbach, CEO of Valneva said:
“Valneva is delighted to announce this partnership with CEPI. Chikungunya infection is a major unmet medical need and we believe that our single-shot vaccine is uniquely positioned to provide optimal protection in all outbreak situations for people living in areas where Chikungunya occurs and also for travelers to these regions. We continue to invest heavily in the program and look forward to working with CEPI on the project. We plan to enter the pivotal study phase of our vaccine as soon as possible in close alignment with the US FDA, with the aim of an accelerated approval.”
BioFire Defense, LLC, an affiliate of bioMérieux and leader in pathogen detection systems for the U.S. Department of Defense, was awarded the 2019 James S. Cogswell Outstanding Industrial Achievement Award from the DoD’s Defense Security Service (DSS). This award was presented to the company’s facility located in Salt Lake City, Utah, as a reflection of the sites dedication to our national security interests. BioFire Defense was selected as one of 51 recipients, from among more than 13,000 defense contractors.
To be considered for this award, BioFire Defense has established and maintained a comprehensive security program that effectively meets or exceeds National Industrial Security Program requirements. Additionally, they were required to have a minimum of two consecutive superior industrial security review ratings, which shows a sustained degree of excellence and innovation in their overall security program management, implementation, and oversight.
The James S. Cogswell Award was established in 1966 and is the most prestigious recognition by the Federal government for a cleared defense contractor that demonstrates industrial security excellence. Once initially nominated, the nominees go through a vigorous national vetting process that includes external vetting and a national team review. The national review team then consolidates and ranks the nominations, and that ranked listing is submitted to the Director of DSS for final approval.
“Credit for this accomplishment goes to Kim David, our Facility Security Officer, and her team,” said Robert Lollini, CEO of BioFire Defense. “With the support of all those whom they have trained on security, their diligence and vigilance serves to protect our national security but also our national and corporate economic interests from ever evolving internal and external threats.” Winners were announced at the 2019 Annual Conference of National Classification Management Society (NCMS), the society of industrial security professionals, in St. Louis, Missouri on June 12, 2019.
Abstracts being accepted now.
Whether an industrial accident affecting water, or a viral outbreak such as African Swine Fever, or even a radiological accident like Fukushima, decontamination is one of the critical challenges facing our communities. When communities are faced with recovering from a major chemical, biological, or radiological (CBR) incident, as well as natural disasters such as hurricanes that result in contaminated waste, it is important to have all the relevant research and science available.
This conference is designed to facilitate presentation, discussion, further collaboration on research and development, and application of tools and research focused on an all-hazards approach to cleaning up contaminated buildings (both interior and exterior), infrastructure, and other areas/materials. The conference continues to focus strongly on matters involving CBR threat agents but also includes all hazard elements. The conference brings together researchers, first responders, community leaders and planners, and industry.
For more information, and to register, please visit: https://www.epa.gov/homeland-security-research/2019-epa-international-decontamination-research-and-development
Sgt James Monaghan is holding a charity auction night on September 21st 2019 for a very good cause, the ABF - The Soldiers Charity - Helping Soldiers, Veterans, and their Families.
James has done a heck of a job and secured some fantastic pieces for the auction which is being held at Winterbourne Gunner. If you can't attend you can still donate to the cause by visiting the Just Giving page James has set up.
For more information about the event, you can contact James at or on 01722 436 096.
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