FREDERICK, Md., Aug. 18, 2023 /PRNewswire/ -- Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, including Lassa Fever (LF), today announced publication of data demonstrating that Arevirumab-3®, its lead immunotherapeutic candidate, is an effective therapeutic for the treatment of Lassa virus infections, with activity against all major viral lineages that cause severe disease in humans, and at very low dosages.
The study emanated from an extensive and ongoing research collaboration of Zalgen, Tulane University (Tulane), UTMB, and other members of the Viral Hemorrhagic Fever Consortium (VHFC) [www.vhfc.org] and the Viral Hemorrhagic Fever Immunotherapeutic Consortium (VIC) [www.vhfimmunotherapy.org] working on advanced alternatives to treat Lassa fever and other hemorrhagic viral infections.
The just released publication: A human monoclonal antibody combination rescues nonhuman primates from advanced disease caused by the major lineages of Lassa virus, Cross RW, et al. (DOI number 10.1073/pnas.2304876120) is the latest in a series of scientific reports from Zalgen studies at UTMB. This study, in conjunction with the previously reported high-resolution structures of Arevirumab-3 antibodies, docked on the viral glycoprotein (Li H et al. A cocktail of protective antibodies subverts the dense glycan shield of Lassa virus. Sci Transl Med. 2022 Oct 26;14(668)) form the core of a recently reviewed pre-Investigational New Drug (pre-IND) application by the U.S. Food and Drug Administrations (FDA). Arevirumab-3 is now on a path toward IND, with projected Phase 1 clinical studies to assess the safety and immunogenicity of the drug in healthy human subjects.
"The ultimate goal of this program is to complete the clinical evaluation of Arevirumab-3 as a novel drug for the treatment of active Lassa fever, as well as its potential use as a prophylactic," stated Luis M. Branco Ph.D., Zalgen Managing Director. "Arevirumab-3 is the first drug to be developed specifically for the treatment of Lassa fever, a viral hemorrhagic fever widely regarded as a leading pandemic concern."
Lassa fever is a dangerous, often fatal disease common to much of West Africa, with children and pregnant women being the highest risk groups; the 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.
"The results of these studies demonstrating 100% effectiveness in 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 of Zalgen.
The current study established that Arevirumab-3 is poised to offer a therapeutic option for a viral hemorrhagic fever that causes significant mortality and morbidity throughout the West African subcontinent, and for which there are very limited and largely ineffective options. Zalgen, UTMB, and Tulane are conducting additional studies to explore further the utility of Arevirumab-3 against divergent and emerging strains of the Lassa virus. The development path of Arevirumab-3 exemplifies how state-of-the-art complex immunotherapeutics are developed, tested, and progress toward human use.
Development of Aruvirumab-3 was supported by the National Institutes of Health (NIH) grants BAA NIAID-DAIT-NIHAI2008031, 1R01AI104621-01, 1U19AI109762-01, 1R01AI132223-01, 1R43AI120472-01, and peripherally by 5R44AI115752-02, 1U01AI082119-01, and 1UC1 AI067188-01.
About Zalgen Labs
Zalgen Labs is a biotechnology and diagnostics company headquartered in Frederick, 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 developing and commercializing immunotherapeutics, novel vaccines, and reliable, rapid, and affordable diagnostic platforms targeting neglected and underrepresented human infectious diseases. For more information, visit www.zalgen.com.