Unlocking the Future of Infectious Disease Research:
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[Rockville, MD, April 2025] A promising new therapeutic is being developed to address the urgent need for effective treatments for Marburg virus disease (MVD), a highly fatal viral infection. Currently, no FDA-approved medical countermeasures (MCMs) exist for the treatment of Marburg virus (MARV). A human monoclonal antibody (mAb) derived from a survivor of a natural MARV infection, is being explored as a potential treatment.
The mAb works by targeting the MARV glycoprotein (GP) near the receptor binding domain, preventing the virus from attaching to and entering host cells. This innovative therapeutic is advancing through development under the FDA’s Animal Rule regulatory pathway, as human clinical trials for MARV are not ethical or feasible except during outbreak situations.
One key concern in the development is the potential for the virus to develop resistance. As the mAb neutralizes MARV, mutations in the GP binding region may occur, leading to the emergence of viral variants. To mitigate this, an important focus of the project is identifying and analyzing any resistant variants.
To assess the efficacy of the mAb, IBT Bioservices is developing a fit-for-purpose cell based neutralizing assay that accurately measures mAb’s neutralizing ability using IBT’s advanced Marburg virus pseudovirus platform. This system uses a vesicular stomatitis virus (VSV) pseudotyped with the full-length MARV GP to model viral infection in a safe, single-round replication assay, conducted under biosafety level 2 (BSL-2) containment. The platform will be used to determine the NT50 of mAb; the concentration needed to neutralize 50% of the virus.. Furthermore, to test for potential MARV GP variants identified in preclinical studies, IBT is generating recombinant pseudoviruses incorporating polymorphisms within the Marburg virus (MARV) glycoprotein (GP) target binding region to investigate viral escape and enhance our understanding of viral emergence. Neutralization activity against these pseudoviruses will be assessed using the fit-for-purpose assay to evaluate the impact of GP polymorphisms on the antibody activity.
IBT Bioservices provides cutting-edge laboratory services specializing in clinical and preclinical testing to support the development of biologics and vaccines in a safe, regulated environment.
For any inquiries, please contact:
Mr. Siddharth Rohankhedkar
srohan@integratedbiotherapetics.com
services@ibtbioservices.com
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