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November 28, 2015 6:54 AM ET


Company Overview of Elusys Therapeutics, Inc.

Company Overview

Elusys Therapeutics, Inc. is a biopharmaceutical company that focuses on the development of antibody therapeutics for the treatment of a life-threatening infectious disease. The company offers Anthim, an anti-toxin antibody for the treatment and prophylaxis of inhalational anthrax disease following a biowarfare attack. Its Anthim targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to protective antigen. Elusys Therapeutics, Inc. was formerly known as ErythroMed, Inc. The company was founded in 1998 and is based in Pine Brook, New Jersey.

25 Riverside Drive

Unit One

Pine Brook, NJ 07058

United States

Founded in 1998





Key Executives for Elusys Therapeutics, Inc.

Chief Executive Officer, President and Director
Senior Director of Human Resources & Administration
Vice President of Corporate Development
Age: 53
Vice President of Development and Manufacturing
Vice President of Regulatory Affairs
Compensation as of Fiscal Year 2015.

Elusys Therapeutics, Inc. Key Developments

Elusys Therapeutics, Inc. Receives First Delivery Order from U.S. Government for Anthim

Elusys Therapeutics, Inc. announced it has been awarded its first delivery order under a procurement contract for Anthim (obiltoxaximab), an investigational agent for the treatment of inhalational anthrax infection, valued at $44.9 million. The delivery order was issued by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (HHS ASPR), for acquisition of Anthim into the Strategic National Stockpile (SNS) as a countermeasure against a potential bioterrorist attack.

U.S. Food And Drug Administration Accepts Biologics License Application for Anthim of Elusys Therapeutics, Inc

Elusys Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for filing and review its Biologics License Application (BLA) for Anthim (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness. Anthim has been developed under Fast-Track status and Orphan Drug Designation by the FDA. Inhalation anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation's top biowarfare threats. Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. Inhaled anthrax is often fatal, despite treatment with antibiotics. In the 2001 anthrax letter attacks, inhalational anthrax had a fatality rate of approximately 50% in humans infected, even when victims were given antibiotics and supportive hospital care. Under current guidelines, CDC recommends the use of anthrax antitoxins with antibiotics in cases where there is a high level of clinical suspicion for systemic anthrax. The filing acceptance is based on submission of efficacy data studied in animal models of inhalational anthrax and safety data from 350 healthy human volunteers receiving the proposed human therapeutic dose of Anthim administered intravenously. Anthim is a high-affinity monoclonal antibody in development for the treatment and prevention of inhalational anthrax, a top bioterror threat. Anthim is formulated as a solution and is the only anthrax anti-toxin in advanced stages of development that is being investigated for intravenous (IV) treatment and intramuscular (IM) prophylaxis administration. IV administration is being evaluated for the treatment of patients who have established infection and are symptomatic for anthrax disease, as well as for prophylaxis. Prophylaxis includes immediate pre-exposure prophylaxis (as in the case of emergency personnel responding to an event) and post-exposure prophylaxis (when there is reason to believe a person may have been exposed to anthrax but prior to signs/symptoms of infection).

Elusys Therapeutics, Inc. Reports Efficacy of its Anthrax Anti-Toxin in Post-Exposure Prophylaxis in Animal Studies

Elusys Therapeutics, Inc. presented data demonstrating that obiltoxaximab (ETI-204) demonstrated a statistically significant survival benefit across a range of disease severity in animal model studies assessing treatment of inhalational anthrax, as well as effectiveness in post-exposure prophylaxis. Obiltoxaximab is the company's investigational monoclonal antibody (mAb) anthrax antitoxin for the treatment and prevention of inhalational anthrax used in a bioterror attack. Study results were highlighted in poster presentations at the ASM Biodefense and Emerging Diseases Research meeting in Washington, DC. Obiltoxaximab is in late stage development, and is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness. In the first presentation, results of four studies conducted in a monkey treatment model of inhalational anthrax were discussed; survival to 28 days was the primary endpoint. There was significant survival for the majority of obiltoxaximab treatment groups (5/8) over placebo groups (p<0.025). Statistically significant obiltoxaximab survival benefit versus placebo were demonstrated across a range of disease severity. Survival outcomes were shown to be dependent on severity of disease prior to treatment as measured by the amount of bacteria in the blood; 16 mg/kg of ETI-204 was determined to be the maximally efficacious dose. A second presentation by Elusys demonstrated significant efficacy in two studies in monkeys. In both studies, obiltoxaximab was dosed via a single intramuscular injection (IM) at 16 mg/kg, 18-48 hours following challenge with aerosolized B. anthracis spores. Survival to day 28 or day 56 was the primary endpoint. In the first study, obiltoxaximab survival was 100%, 83% and 50% at 18, 24 and 36 hours compared to zero survival in the placebo group. In the second study, obiltoxaximab survival was 93%, 43%, and 25% at 24, 36 and 48 hours compared to 10% in placebo. IM obiltoxaximab was significantly efficacious compared to placebo when given at 18 and 24 hours post-exposure, and provided increased protection compared to controls at 36 and 48 hours post-exposure. Obiltoxaximab prevented development of Protective Antigen (PA) toxemia and bacteremia in the majority of animals when administered at 18 or 24 hours post challenge, and effectively neutralized serum PA in animals treated at 36 and 48 hours post challenge.

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