MUMBAI, India & HYDERABAD, India:  PopVax, an Indian full-stack biotechnology company developing novel mRNA vaccines and therapeutics using machine learning-enabled computational protein design, is pleased to announce that it has been selected for inclusion in the U.S. Government’s Project NextGen. As part of this initiative, the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), will conduct and sponsor the Phase I first-in-human trial of the company’s next-generation COVID-19 vaccine candidate. This trial, which will be conducted in the United States and is expected to begin in early 2025, is intended to evaluate the safety and immunogenicity of the vaccine candidate in healthy human participants.

The vaccine candidate is based on PopVax’s innovative architecture for the display of immunogens on mRNA-encoded self-assembling virus-like particles (VLPs), and uses one of PopVax’s lipid nanoparticle (LNP) formulations featuring a PopVax-designed novel lipid. In preclinical studies, PopVax’s COVID-19 vaccine constructs elicited an antibody response in mice that resulted in 10-100x more potent neutralization of key SARS-CoV-2 variants as compared with the sequences from existing mRNA COVID-19 vaccines approved in the U.S. Formulated mRNA-LNP material for the clinical trial will be manufactured at PopVax’s new cGMP-ready RNA Foundry facility in Hyderabad, demonstrating PopVax’s concept-to-clinic capabilities in mRNA vaccine development.

“We are delighted that our COVID-19 vaccine has been selected as a candidate for Project NextGen, and the PopVax team is excited to work with the experienced scientists and clinicians at NIAID’s Division of Microbiology and Infectious Diseases to test the safety of our vaccine candidate and technology platform in a clinical study for the first time, as well as to collect early indicators of the product’s ability to elicit a potent and broad immune response,” said Soham Sankaran, Founder & Managing Director of PopVax. “While the threat from COVID-19 is not as acute as it once was, we believe that it is essential to develop vaccines that can protect those among us still vulnerable to this disease, as well as guard against a resurgence of SARS-CoV-2 infection by anticipating and cutting off potential evolutionary pathways of the pathogen.”

Project NextGen (https://aspr.hhs.gov/NextGen/) is a U.S. Government initiative to rapidly translate innovative new vaccines and therapeutics against COVID-19 and other public health threats from the lab into wide availability. The initiative is a collaboration between NIAID and the Biomedical Advanced Research and Development Agency (BARDA), both part of the U.S. Department of Health and Human Services (HHS).

PopVax (https://popvax.com) has developed a novel mRNA architecture for immunogen display on virus-like particles (VLPs), a lipid nanoparticle (LNP) delivery platform for mRNA using PopVax-designed novel ionizable lipids, and a machine learning-enabled computational approach to protein design. Together with the company’s cGMP-ready infrastructure and process for clinical dose production, these platforms collectively form the foundation of PopVax’s ability to rapidly take new mRNA biomedicines from concept to clinic. Founded in late 2021, and previously incubated at the Centre for Cellular and Molecular Biology (CSIR-CCMB), PopVax now employs 70 people across its computational, experimental, analytical, process development, and quality teams at the RNA Foundry, its integrated R&D and process development facility in Hyderabad. The company’s work has been funded in part via project agreements with the Bill & Melinda Gates Foundation and with Balvi, a global health and biosecurity organization started by Ethereum co-founder Vitalik Buterin. PopVax has six novel vaccine candidates in its preclinical pipeline, and intends to initiate five clinical trials over the next two years.

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