– Study is the Company’s first trial evaluating ability of M2SR and the current licensed standard of care to protect against drifted virus strains, and its second study in older adults, a population most vulnerable to mortality from flu –
– Safety and immunogenicity study expected to begin in Q2 2022 –
MADISON, Wis., July 1, 2021 /PRNewswire/ — FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases, today announced that it has been awarded funding from the United States Department of Defense to conduct a safety and immunogenicity study of M2SR, the Company’s investigational, supra-seasonal, live, single-replication, intranasal influenza (flu) vaccine. This study will evaluate a monovalent H3N2 flu vaccine candidate, as compared to a licensed quadrivalent vaccine that is considered the current standard of care for adults aged 65 and above. The study is designed to measure a breadth of immune responses against both vaccine matched and drifted influenza strains amongst study subjects who receive either vaccine alone, both vaccines administered simultaneously, or both given sequentially. The study will also assess seroconversion and seroprotection to identify the number of subjects who respond with antibodies to drifted strains of the flu virus. Protecting against drifted strains, particularly H3N2, has been a challenge over the last decade, as evidenced by research conducted by the Centers for Disease Control (CDC) showing that H3N2 flu viruses tend to undergo more genetic changes, and as such, can lead to a mismatch between the vaccine strain and those that circulate during the flu season. Additional endpoints of this study will look at mucosal and cellular immune responses, areas which are not typically seen with intramuscularly delivered flu vaccines.
“We are extremely pleased to have been awarded funding from the Department of Defense to conduct this important study and further evaluate the ability of M2SR to address virus drift in a highly vulnerable patient population,” said Paul Radspinner, President and Chief Executive Officer, FluGen, Inc. “FluGen is committed to ensuring older adults are protected from the flu virus, and particularly drifted strains, and the current standard of care has not been shown to be widely effective in protecting this population from virus drift, particularly against H3N2. We believe M2SR has the potential to be a more effective vaccine option in older adults, as it induces a broad antibody response, including mucosal, humoral, and cellular immunity, even in the presence of pre-existing immunity to the flu. This represents a critical advancement in flu protection, and we look forward to initiating our study in the second quarter of 2022 and demonstrating the potential seroconversion and seroprotection benefits of our investigational flu vaccine particularly against drifted strains.”
This integrated, Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and immunogenicity of Cambodia 2021 H3N2 M2SR influenza A vaccine (M2SR) in older adults (n=300), >65 years of age. In the proposed study, M2SR, the high dose flu vaccine, or placebo will be administered in different dosing regimens, which will allow for the evaluation of the immunogenicity of M2SR on its own or when sequentially or co-administered with the inactivated vaccine. This design will also enable direct measurement of the breadth of immune responses generated by M2SR and the standard of care vaccine in older adults. The study will be initiated in the second quarter of 2022, which is aligned with the next flu season.
The study is supported by a $11.4 million grant from the Department of Defense. The U.S. Army Medical Research Acquisition Activity is the awarding and administering acquisition office and this work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program under Award No. W81XWH2110563. The views expressed in this article are those of the author and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. government.
FluGen, Inc. is a clinical-stage vaccine company transforming vaccine efficacy in respiratory diseases. The company’s lead candidate is M2SR, a supra-seasonal, live, single-replication, intranasal flu vaccine. Unlike standard of care flu vaccines, M2SR stimulates mucosal, humoral, and cellular immunity. In an unprecedented challenge trial, M2SR demonstrated protection against infection and illness across seven years of virus drift; and M2SR induces a durable antibody response with potential to cover an entire flu season and beyond. M2SR also has shown activity as a vaccine vector for other respiratory vaccines and infectious diseases, including a COVID-19/flu combination.