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Ebola Therapy mAb114 Receives $14 million in Funding

It was annonuced on September 24th that the Biomedical Advanced Research and Development Authority (BARDA) intends to provide $14 millio, as well as expertise support for the advanced development of an investigational Ebola treatment being pursued by Ridgeback Biotherapeutics of Miami.

mAb114 is a monoclonal antibody that works by binding to virus proteins, reducing thier ability to infect human cells. The therapy has already received Breakthrough Therapy Designation from the FDA, and Ridgeback Biotheraputics intends to apply for licensure also. 

The antibody was initially isolated and developed by scientists from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases in collaboration with the Institut National de Recherche Biomedicale, the Institute for Research in Biomedicine, and the U.S. Army Research Institute of Infectious Diseases. 

“Effective Ebola therapeutics are essential in saving lives not only in the current outbreak in the DRC but also in future outbreaks anywhere in the world and to discourage any potential use of this virus in bioterrorism,” BARDA Director Rick Bright said. “Combating this horrific disease requires every tool we can provide to healthcare providers and patients.”

mAb114 is currently being used in the DRC to help combat the ongoing Ebola outbreak, under a clinical trial known as PALM. NIAID and the National Biomedical Research Institute are co-sponsoring that trial.

Protection, Biological

FDA Approve Smallpox/Monkeypox Vaccine

The FDA has approved the Jynneos vaccine by Bavarian Nordic for the prevention of Smallpox and Monkeypox in adults 18 years of age and older determined to be at high risk for these infections.

Jynneos is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus; this modified form of the vaccinia virus does not cause disease in humans and cannot reproduce in human cells. 

The effectiveness of the vaccine against smallpox was inferred by comparing the immunogenicity of Jynneos to the licensed smallpox vaccine ACAM2000 from Emergent Biosolutions. In the study, immune response with Jynneos (2 doses administered 28 days apart) was found to be noninferior to the comparator vaccine (1 dose) in healthy participants with no vaccination history for smallpox. 

The effectiveness of the vaccine against monkeypox was inferred from antibody responses in the smallpox clinical study as well as from studies of non-human primates who were exposed to the monkeypox virus following vaccination with Jynneos.

Protection, Biological

Airboss Wins DOD Contract for CBRN Overboot

AirBoss of America Corp. today announced that AirBoss Defense has been awarded an indefinite delivery/indefinite quantity (IDIQ) contract from the U.S. Department of Defense for the manufacture and sale of up to 600,000 pairs of Molded CBRN Lightweight Overboots (MALO). The contract is expected to be worth up to an aggregate amount of US$26.7 Million. To date, AirBoss Defense has received one order under the contract for 84,800 pairs of MALOs, worth approximately US$3.8 million. The delivery period for this initial order is anticipated to be from Q2 2020 through Q3 2020.

The MALO, made with an injection-molded advanced specialty polymer, was originally designed and developed to provide superior physical properties and protection compared to chemical, biological, radiological and nuclear (CBRN) overboots then in service, and fully integrates with all currently fielded CBRN Suits. The MALO has been broadly adopted worldwide and been used in more than 40 countries. To date AirBoss has sold more than 445,000 pairs of MALO boots.

Equipment, CBRNe, Contract

MCDC Award $20 Million Contract for Development of Auto-Injector

Emergent BioSolutions Inc.  announced on September 25th that it has been awarded approximately $20 million to develop and manufacture an auto-injector containing diazepam (5 mg/mL) to treat nerve agent-induced seizures. Emergent’s device is being designed for intramuscular buddy-administration for use in military environments and for civilian emergencies.

Doug White, SVP and devices business unit head at Emergent BioSolutions, stated, “Emergent is pleased with this follow-on contract, which expands our opportunities to serve the needs of the Department of Defense (DoD) for modern and reliable auto-injectors to protect our military personnel against nerve agents. We are committed to meeting our customers’ high expectations and leverage our more than 20-year history of successfully partnering with governments in addressing public health threats.”

Under the multiple year agreement, awarded through the Medical CBRN Defense Consortium (MCDC), Emergent will develop a device, conduct studies to demonstrate consistent manufacturing, functionality, and usability of the final device, and complete regulatory activities required to obtain approval of the combination product by the U.S. Food and Drug Administration (FDA).

The MCDC was established by the Joint Project Manager for Medical Countermeasure Systems. It is a DoD initiative within the Joint Program Executive Office for Chemical and Biological Defense that provides U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats.

CBRNe, Chemical, Protection, Contract

Biofactura Awarded $67.4 Million to Develop Smallpox Biodefense Therapeutic

BioFactura, Inc. announced on September 26th a contract awarded by the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $67.4 million for the advanced development of its Smallpox Biodefense Therapeutic as a potential medical countermeasure (MCM) for the treatment of smallpox.  This product has the potential to fulfill an unmet need in preparedness for a second anti-viral therapeutic with a different mechanism of action to the current stockpile to guard against potential host resistance.

Variola Virus (VARV), the causative agent for smallpox infections in humans, can become resistant to treatment suggesting that the best medical countermeasure approach would utilize complementary therapeutics.  To fill the need for additional treatment options, BioFactura, in partnership with BARDA, is advancing the development of its monoclonal antibody-based Smallpox Biodefense Therapeutic in a stepwise approach building upon years of early product research and development and a strong foundation of cell line, process, analytical and manufacturing development experience and expertise.

Dr. Darryl Sampey, President and CEO of BioFactura, stated, “This advanced research and development contract award marks the culmination of decades of discovery and development work performed by our team, our partners at the National Institutes of Health and our principal government collaborator Dr. Jay Hooper at the U.S. Army Research Institute of Infectious Diseases.  We look forward to working with BARDA in this new chapter of product development as we bring an important defense to our citizens.”

“This government contract for the development of a novel smallpox therapeutic countermeasure is the result of years of cutting edge biotechnology research, the perseverance of forward-thinking scientific entrepreneurs, the risk appetite of loyal investors, and the dedication of the Department of HHS/BARDA to maintain the safety and security of the United States population,” stated Dr. Jeffrey Hausfeld, BioFactura’s Chief Medical Officer and Chairman. “It is truly an evolving American success story and one which as a physician and Chairman of the Board of BioFactura, I am proud to be a part of.”

CBRNe, Protection, Biological, Contract

Kromek awarded two contracts for D3S products

Kromek, a worldwide supplier of detection technology focusing on the medical, security screening and nuclear markets, announced today that it has been awarded two extension contracts relating to its D3S family of products and technologies designed to counter nuclear terrorism. The contracts are worth an aggregate of approximately £1.6m and will be delivered in this current financial year.

The US Government’s Countering Weapons of Mass Destruction Office, which is a component within the US Department of Homeland Security, has awarded Kromek a $0.7m (c. £0.6m) extension contract to add further technical innovation capability to the D3S family of products. The enhancements will provide greater operational capability by improving user experience and add a specialised reporting function to generate further information for homeland security organisations.  

The Group has also been awarded a £1.0m contract extension by a European government-related company to provide integration of Kromek’s D3S-related technologies. The customer is a company that works with a European government to detect and protect against potential nuclear threats, and the Group’s solutions will be used for wide-area threat monitoring. This brings the total awarded by this customer during this financial year to £2.1m.

 

Detection, Radiological, Contract

Bertin Announce 2 Newcomers for Biological Threat Sampling

Bertin’s teams are proud to announce the release of 2 new air sampling equipment for biological air monitoring or biological recognition missions:

– The Coriolis Compact: dry cyclonic collector intended for air monitoring in a biological threat context.

– The Coriolis Nano: ultra-portable electrostatic biological collector intended for armed forces’ personal exposure monitoring.

This new equipment is both easy to handle and transport and can also be embarked on drones or vehicles. It continuously collects and concentrates the biological agents of potential threats in the air, up to 8 hours. The particles collected can then be analyzed to ensure biological threat detection and identification. The Coriolis air samplers are the first part in the biological detection chain and provide the CBRN detection and identification equipment with well concentrated biological agents samples.

Visit Bertin on booth #37 at the CBRNe Protection Symosium from 24 to 26 September 2019 in Malmö, Sweden, to learn more about the new Coriolis range. 

 

Detection, Identification, CBRNe, Biological

LLNL Nerve Agent Antidote Shows Great Potential

Scientists at the Lawrence Livermore National Laboratory have been working with live agent, supercomputers, and accelerated mass spectrometry, to develop a new nerve agent antidote, namely LLNL-02. 

Their work has been showing great promise, and with somw refinement of the LLNL-02 antidote and identifying a second potential candidate molecule, they are working towards approval of LLNL-02 by the FDA. 

You can read all about the work thay have beem doing, and how in this research highlight article from LLNL. 

CBRNe, Chemical, Protection, R&D

Ebola Bombali Detected in Guinea

Researchers from The University of California, Davis, have recenctly publsihed their findings regarding the discovery of the sitxth ebolavirus, Bombali, in Angolan free-tailed bats roosting inside people’s houses in Guéckedou and Kissidougou, Guinea. 

The team from UC Davis One Health Institute first discovered the Bombali virus in Angolan and little free-tailed bats in Sierra Leone. This is the first time a strain of ebola has been detected in an animal resevoir before being detected in a sick human or animal. Various research teams have been on the lookout for Bombali since the UC Davis team frist discovered it, and from reults It appears that Bombali has a wide disrtibution. 

Bombali is distinct from the other five strains of ebola, and teams of scientists are currently trying to ascertain whether Bombali has spilled from it's bat resevoir in to the human populace. At present tests show that Bombali can infect human cells and studies are ongoing to ascertain the risk it poses. 

 

Threat, Biological, R&D

Children Attacked with "Irritant Gas"

Ten children and their teacher were attacked at a train station in Germany by a perpetrator using what has been referred to as an "irritant gas".

A 39 year old man apparently approached the group and sprayed them with a yet unnamed substance. The children were initially treated at the scene, having their eyes flushed and faces rinsed. Some of them were also suffering from shortness of breath. 

Threat, CBRNe, Chemical

Read more …Children Attacked with "Irritant Gas"

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