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Zalgen Immunotherapeutic Demonstrates 100% Effectiveness Against Advanced Lassa Infections in Non-Human Primates

WASHINGTON D.C. – 5 Sep, 2017 – Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases including Lassa Fever (LF), today announced that Arevirumab-3, its lead immunotherapeutic candidate, was tested in Non-human primates (NHP) infected with Lassa virus and demonstrated 100% protection.  The study emanated from an extensive research collaboration of the Viral Hemorrhagic Fever Consortium (VHFC) and the Viral Hemorrhagic Fever Immunotherapeutic Consortium (VIC) working on advanced alternatives to treat Lassa fever infections.

 

Researchers at UTMB successfully tested Arevirumab-3, a cocktail of human monoclonal antibodies developed by Zalgen and Tulane University (Tulane). This first-in-class seminal study was published in the September 4, 2017 issue of the journal Nature Medicine (Mire, et al., DOI 10.1038/nm.4396). Arevirumab-3 and its individual component antibodies have now demonstrated 100 percent efficacy in two relevant animal model systems, and will advance to pre-clinical development, with projected Phase I studies within three years.

Lassa fever is a dangerous, often fatal disease common to much of West Africa with children and pregnant women being the highest risk groups; early stages of the disease are difficult to distinguish from other diseases. Lassa fever is spread by contact with infected rodents and is estimated to infect 300,000 to 500,000 people per year across the region, with at least 5,000 deaths annually. The illness is characterized by bleeding and coagulation abnormalities, with mortality rates reported exceeding 25 percent and reaching 50 percent during epidemics.

Article in Nature Medicine reports data from study at the University of Texas Medical Branch at Galveston (UTMB) showing protection against Lassa Fever, a major threat to global health.

“The fact that Arevirumab-3 was able to rescue 100% of monkeys more than a week after infection with Lassa virus suggests that this therapy may benefit patients with Lassa fever in West Africa, who often present to the clinic at a late stage of disease,” said Robert F. Garry, Ph.D., Co-Founder and Chief Scientific Advisor of Zalgen Labs. “We are accelerating further development of Arevirumab-3 so that this promising treatment can be introduced into clinics in West Africa and deployed as a deterrent against the use of Lassa virus as a bioweapon.”

“Arevirumab-3 was specifically designed to target all known circulating strains of Lassa virus, and to date has demonstrated remarkable potency in vivo and in preventing the emergence of escape mutants, an important consideration when developing antivirals,” said Luis M Branco, Ph.D., Managing Director and Co-Founder of Zalgen Labs. “the studies published yesterday in Nature Medicine demonstrate the value of immunotherapy in reducing viral load, metabolic, and hematologic dysregulation resulting from Lassa virus infections”.

“Successful deployment of Arevirumab-3 to Lassa fever endemic regions will close the circle for West African countries to quickly diagnose Lassa fever with point-of-care diagnostics and provide an effective therapeutic response to those afflicted. Availability of Arevirumab-3 would also mitigate risk of exported Lassa cases out of West Africa which has registered increased incidence over the last several years,” said Matthew L. Boisen, Ph.D., Director of Diagnostics Development at Zalgen Labs Diagnostics Division.

Development of Aruvirumab-3 was supported by the National Institutes of Health (NIH) grants BAA NIAID-DAIT-NIHAI2008031, 1 R01 AI104621-01, 1 U19 AI109762-01,  1R01AI132223-01, 1 R43 AI120472-01, and peripherally by 5 R44 AI115752-02, 1 U01 AI082119-01, and 1 UC1 AI067188-01

About Zalgen Labs

Zalgen Labs is a biotechnology and diagnostics company with headquarters in Germantown, Md., and an advanced diagnostic product development center in Aurora, Colo. The company specializes in the design and production of superior biological molecules critical for the development and commercialization of immunotherapeutics, novel vaccines, and reliable, rapid and affordable diagnostic platforms targeting neglected and underrepresented human infectious diseases.

For more information, visit www.zalgenlabs.com

About the Viral Hemorrhagic Fever Immunotherapeutic Consortium

The Viral Hemorrhagic Fever Immunotherapeutic Consortium was established in 2014 to develop life-saving antibody therapeutics against some of the world’s deadliest viruses. The VIC represents a field-wide collaboration in which leading laboratories around the world have united to understand what features lead to antibody-mediated protection against these viruses and how we can more rapidly discover ideal treatments. This collaborative effort allows each laboratory to contribute their strengths in analytical techniques towards the identification, characterization, and validation of antibodies against the Filoviridae and Arenaviridae families. From isolating novel antibodies and testing them in vivo, to the structural analysis of the molecular mechanisms of neutralization, VIC scientists contribute unique insights towards the overall characterization of a broad pool of antibodies. The consortium is funded through a National Institute of Health National Institute of Allergy and Infectious Diseases Centers for Excellence in Translational Research program grant.

For more information, visit www.vic.org

About the Viral Hemorrhagic Fever Consortium

The Viral Hemorrhagic Fever Consortium was established in 2010 as a result of several multi-year grants and contracts awarded to Tulane University by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to support Tulane’s ongoing efforts to treat and prevent Lassa fever.

For more information, visit www.vhfc.org

Zalgen Company Contact
Luis M. Branco, Ph.D. – Managing Director and Co-Founder
Phone (504) 444-7047
[email protected]

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