Elusys Therapeutics is a

biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...

company founded in Pine Brook, New Jersey in 1998. The company specializes in the development of antibodies for the treatment

infectious disease An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dise ...

s. The antibodies are developed from protein complexes called heteropolymers which can bind to specific

pathogen In biology, a pathogen ( el, πάθος, "suffering", "passion" and , "producer of") in the oldest and broadest sense, is any organism or agent that can produce disease. A pathogen may also be referred to as an infectious agent, or simply a germ ...

s on one side and red blood cells on the other side. The pathogens will be dragged to the liver where they will be destroyed. The antibodies have a potential to be used for the treatments of many blood-borne diseases. Currently, the company focuses on the late-stage clinical trials of Anthim (

Obiltoxaximab Obiltoxaximab, sold under the brand name Anthim, is a monoclonal antibody medication designed for the treatment of exposure to ''Bacillus anthracis'' spores (etiologic agent of anthrax). The medication was developed by Elusys Therapeutics, Inc. * ...

) to be used for treatment and prevention of inhaled

anthrax Anthrax is an infection caused by the bacterium ''Bacillus anthracis''. It can occur in four forms: skin, lungs, intestinal, and injection. Symptom onset occurs between one day and more than two months after the infection is contracted. The sk ...

History

Ronald P. Taylor, a professor of biochemistry and molecular genetics at the

University of Virginia The University of Virginia (UVA) is a Public university#United States, public research university in Charlottesville, Virginia. Founded in 1819 by Thomas Jefferson, the university is ranked among the top academic institutions in the United S ...

developed protein complexes called heteropolymers that mimic the natural process of white and red blood cells in clearing out the disease off the bloodstream. The heteropolymers have specific binding that can bind to specific

s on one side and red blood cells on the other side. The red blood cells with the attached pathogens are delivered to the liver to be destroyed. In animal testing, the method can clear out pathogens within 2 hours. Taylor's research were partially funded by the

National Institutes of Health The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...

and the

Defense Advanced Research Projects Agency The Defense Advanced Research Projects Agency (DARPA) is a research and development agency of the United States Department of Defense responsible for the development of emerging technologies for use by the military. Originally known as the Adv ...

Additional funding was arranged by Seed-One Ventures, a

venture capital Venture capital (often abbreviated as VC) is a form of private equity financing that is provided by venture capital firms or funds to startups, early-stage, and emerging companies that have been deemed to have high growth potential or which ha ...

company, through the formation of Elusys Therapeutics to raise several million dollars. Jeff Wolf, the founding CEO Elusys and Managing Partner of Seed-One, selected Stephen Sudovar as the CEO of Elusys. Sudovar was the former President of Roche Laboratories a division of

Hoffmann-La Roche F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX ...

. Wolf also arranged to have Elusys'

board of directors A board of directors (commonly referred simply as the board) is an executive committee that jointly supervises the activities of an organization, which can be either a for-profit or a nonprofit organization such as a business, nonprofit organiz ...

made up of people with prior experience from top global pharmaceutical companies and

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA). As a startup, the company tested its first heteropolymers by using two chemically linked

monoclonal antibodies A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ca ...

for the treatment of

lupus Lupus, technically known as systemic lupus erythematosus (SLE), is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body. Symptoms vary among people and may be mild to severe. Comm ...

. Elusys is a member of the

Alliance for Biosecurity The Alliance for Biosecurity is a consortium of companies that develop products to respond to national security threats, including bioterrorism pathogens and emerging infectious diseases. It is headquartered in Washington DC. Background The Un ...

. The alliance is a group of companies and scholars that work to promote the development of vaccines and other measures that can be used in the case of a pandemic or

bioterrorism Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, insects, fungi, and/or toxins, and may be in a naturally occurring or a human-modified form, in much the same ...

attack.

Treatment

Anthim is monoclonal antibody designed for the treatment of exposure to ''

Bacillus anthracis ''Bacillus anthracis'' is a gram-positive and rod-shaped bacterium that causes anthrax, a deadly disease to livestock and, occasionally, to humans. It is the only permanent ( obligate) pathogen within the genus ''Bacillus''. Its infection is a ...

'' spores (etiologic agent of

). Elusys initially collaborated with

University of Texas at Austin The University of Texas at Austin (UT Austin, UT, or Texas) is a public research university in Austin, Texas. It was founded in 1883 and is the oldest institution in the University of Texas System. With 40,916 undergraduate students, 11,075 ...

and

United States Army Medical Research Institute of Infectious Diseases The United States Army Medical Research Institute of Infectious Diseases (USAMRIID; pronounced: you-SAM-rid) is the U.S Army's main institution and facility for defensive research into countermeasures against biological warfare. It is located ...

(USAMRIID) in the development of Anthim. With the

risk of anthrax, the

United States Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is ...

awarded a five-year contract in 2010 valued at $143 million to develop IV-based drug to treat patients who are already infected by anthrax. In 2011, the company was awarded with an additional five-year contract valued at $68.9 million to develop

intramuscular injection Intramuscular injection, often abbreviated IM, is the injection of a substance into a muscle. In medicine, it is one of several methods for parenteral administration of medications. Intramuscular injection may be preferred because muscles have ...

for anthrax prevention measure. In 2012, the company was awarded additional $50.2 million to test the efficacy of the treatment. The

Biologics License Application A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into inters ...

for both intravenous and intramuscular administrations was accepted by the FDA in June 2015 with efficacy data of animal models and safety data from human volunteers. In March 2016, Anthim was approved to treat inhalational anthrax in conjunction with appropriate

antibacterial An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting bacterial infections, and antibiotic medications are widely used in the treatment and prevention of ...

drugs, also for prevention when alternative therapies are not available or appropriate. In November 2015, the company received a five-year contract of $44.9 million for the production and future delivery of Anthim to the

Strategic National Stockpile The Strategic National Stockpile (SNS), originally called the National Pharmaceutical Stockpile (NPS), is the United States' national repository of antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. Its w ...

References

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