New human trials for novel antibody offer hope for immediate protection against deadly Nipah

July 3, 2024 - Oslo, Norway; San Diego, CA, USA - For Immediate Release

Twenty-five years after the first human outbreak of Nipah virus, a novel Nipah monoclonal antibody—which could offer people at risk of infection immediate protection against the deadly disease—is planned to undergo human clinical trials in India and Bangladesh.

These clinical trials will assess the safety and tolerability of a Nipah monoclonal antibody (mAb), a protein that mimics natural antibodies by binding to the virus and preventing infection, which is designed to protect people in Nipah-affected countries from contracting the disease.

With $43.5 million in funding from CEPI, the human trials are intended to commence in 2025, pending regulatory approval. Led by non-profit biotechnology company ServareGMP and supported by Mapp Biopharmaceutical, the trials will assess the Nipah mAb, MBP1F5, in healthy adults at multiple clinical trial sites in India and Bangladesh—two countries that suffer Nipah outbreaks almost every year.

Funding will also support preclinical studies seeking to expand the use of the mAb from pre-exposure prophylaxis (before someone is exposed to a virus) to post-exposure prophylaxis, that is, for people shortly after infection with the virus.

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ServareGMP, Wadsworth Center, and Wellcome Trust collaborate on ZAC3, a Novel mAb against Cholera

June 15, 2022 - San Diego, CA - For Immediate Release

ServareGMP and Wadsworth Center, with financial support from Wellcome Trust, are developing an ultra low-cost monoclonal antibody (“mAb”) against Vibrio cholera for use in low resource countries and displaced persons settlements where cholera continues to cause substantial disease and death.

The globe is experiencing its 7th cholera pandemic, with the highest incidence of disease concentrated in regions experiencing natural disasters or civil conflicts. V. cholera is transmitted through the consumption of contaminated water and food, with the spread of disease more pronounced when infrastructures break down. Despite the success of oral cholera vaccination, there remains a need for an effective pre-exposure prophylactic for administration in outbreak situations where vaccine implementation is not possible.

Servare’s mAb, ZAC-3, will mitigate against the most severe manifestations of the disease. ZAC-3 has been engineered with serum half-life extension technology, and manufactured using innovative cost reduction strategies, creating radical improvements over prior mAb performance.

By developing an effective, low cost mAb against a highly challenging disease, Servare and its partners intend to demonstrate that effective mAbs are not restricted to high income countries and can be deployed around the globe to address serious unmet needs in a cost-effective manner.

ServareGMP. Servare was formed as a non-profit, charitable public benefit corporation with the intent of creating highly effective biologic drugs against challenging unmet diseases for free to very low cost than those currently available. Servare utilizes its founders’ expertise in the discovery, development, and GMP manufacturing complex large molecules for use in humans. Augmented through strong partnerships with other experts in the space, Servare is creating new therapeutic and prophylactic proteins, vaccines, vectors and cell therapies for underserved, neglected, and vulnerable populations.

The Wadsworth Center. Wadsworth Center is a science-based community committed to protecting and improving health through laboratory analysis, investigations, and research, as well as laboratory certification and educational programs. Scientists at Wadsworth Center study: ongoing public health issues, from drug resistance to emerging infections and environmental exposures; investigate basic biological processes that contribute to human health and disease; employ modern methods, such as biomarkers of exposure, and state-of-the-art technologies, among them a resource for visualizing biologically relevant molecules.

The Wellcome Trust. Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.

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