Meissa Vaccines Receives FDA Clearance of IND Application for a Phase 1 Clinical Trial of MV-012-968 for Respiratory Syncytial Virus

SOUTH SAN FRANCISCO, CA, USA I December 05, 2019 I Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent viral respiratory infections, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to proceed with a U.S. clinical trial of MV-012-968, an investigational vaccine for respiratory syncytial virus (RSV). The company plans to initiate a Phase 1 clinical trial in adults early in 2020 to assess tolerability and immunogenicity of MV-012-968.

RSV is a common respiratory virus that usually causes mild, cold-like symptoms, but RSV infections can be serious, especially for infants and older adults. In children younger than one year of age, RSV is the most common cause of bronchiolitis and pneumonia.1 In children under five, RSV causes more than 30 million new acute lower respiratory infections, resulting in more than three million hospital admissions from serious infections around the world.2

“FDA clearance of this IND for a live attenuated RSV vaccine is a significant milestone in the global mission to prevent RSV in at-risk populations,” said Martin Moore, Ph.D., cofounder and CEO of Meissa. “We look forward to beginning our clinical studies to develop a safe and effective RSV vaccine for infants and the elderly.”

Meissa’s technology platform leverages synthetic biology and genetic engineering for the rational design of vaccines that solve suboptimal immune responses, vaccine stability, and manufacturing. Meissa’s proprietary technologies of reverse genetics and human codon deoptimization allow for rapid generation of live attenuated vaccine candidates that may be safer yet more immunogenic than the natural pathogens.

  1. CDC statistics
  2. The Lancet, 2017

About Meissa Vaccines

Meissa is a private biotech company focused on the advancement of vaccines for respiratory viruses. Meissa was founded on proprietary technologies employing reverse genetics for rational design of more effective live attenuated vaccines. The technology is exclusively licensed from Emory University and Children’s Healthcare of Atlanta. Dr. Moore, together with Dr. Roderick Tang, a vaccine biotech expert, co-founded Meissa. They are supported by a team with extensive experience in all aspects of vaccine development. Meissa is currently a resident company at the Johnson & Johnson Innovation – JLABS in South San Francisco. For more information, please visit www.meissavaccines.com.

SOURCE: Meissa Vaccines

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