Elusys Therapeutics, which is being acquired by Heat Biologics, has finalized a contract with the U.S. Department of Health and Human Services (HHS) for the continued supply of anthrax antitoxin Anthim (obiltoxaximab) for use against a potential anthrax attack.
Completed first phase of contract for $50 million; HHS options to procure up to $31 million of ANTHIM by the first half of 2023
Elusys Therapeutics, Inc., has finalized a contract with the U.S. government for the continued supply of ANTHIM (obiltoxaximab), an anthrax antitoxin for the Strategic National Stockpile of medical countermeasures.
ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.
Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.
ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.
The contract for the procurement of ANTHIM consists of a base period of performance, valued at $50 million, which has been fulfilled. The contract includes options valued up to $31 million. If all options are exercised, the total contract value will be $80,864,000 with completion of the contract expected by the first half of 2023. Contract 75A50121C00073 is funded by HHS ASPR.
As previously announced, Elusys has executed a definitive merger agreement with Heat Biologics, Inc., pursuant to which Elusys will merge into a wholly owned subsidiary of Heat. The acquisition is expected to close during the first quarter of 2022 and is subject to customary closing conditions.
