Advaccine Announces First Participants Dosed in Phase 2 Study of ADV110 Evaluating Respiratory Syncytial Virus (RSV) Vaccine Candidate in Australia

SUZHOU, China I June 4, 2021 I Advaccine Biopharmaceuticals ("Advaccine") announces that the first participants have been successfully dosed in its phase 2 study of ADV110, a respiratory syncytial virus (RSV) prophylactic vaccine candidate, in Australia.

The phase 2 study is a two-center, randomized, double-blind, placebo-controlled and dose-ranging study to evaluate the safety and tolerability of ADV110, where volunteers aged 60 - 80 years healthy adults will be enrolled. Previously, phase I study of ADV110 was completed in Australia and the results demonstrated that ADV110 was safe and well-tolerated for both low and high dose levels and for both single and repeat doses, and showed significant levels of antibody response for most of the subjects, which is more than 90% in low dose groups, and 100% in high dose groups.

"There is a significant unmet need in the global market for a safe and effective vaccine against RSV caused respiratory disease and complications," said Dr. Bin Wang, Chairman of Advaccine, "we believe that the phase II clinical study of ADV110 will further demonstrate the safety and immunogenicity of this novel adjuvanted vaccine designed and developed by Advaccine, and the Company will continue to work actively to accelerate the development of effective solutions to mitigate the impact of RSV on global public health."

RSV is a common respiratory virus that causes a large number of respiratory infections, deaths and heavy economic burden as well every year, while there are no available vaccines or drugs with high efficacy globally. ADV110 is a protein subunit RSV vaccine candidate with a novel adjuvant developed by Advaccine, designed to protect children and the elderly. ADV110 is one of the most clinically advanced RSV vaccine candidates in the world.

About RSV (Respiratory Syncytial Virus):

RSV is a respiratory virus that can spread when an infected person coughs or sneezes, and usually causes cold-like symptoms, it can develop into pneumonia and bronchitis in severe cases. The virus causes infection at all ages, especially for infants, children, old adults and immunocompromised adults, where 96% children under 5 years of age are infected by RSV.

In 2017, the WHO estimated that RSV caused around 33 million serious respiratory infections every year. This results in more than 3 million hospitalizations and nearly 60,000 deaths in children under 5 years of age every year. In 2019, the economic burden of RSV was approximately US$4.2 billion globally. However, there are no available vaccines against RSV or drugs with high efficacy for the treatment of RSV globally.

About Advaccine:

Advaccine is an innovative vaccine company with a high-value prophylactic and therapeutic vaccine pipeline driven by in-house developed technology platforms and industrial manufacturing capabilities. Its pipeline consists of potential first-in-class key assets developed to address diseases caused by SARS-CoV-2, respiratory syncytial virus (RSV) and hepatitis B virus (HBV), which are diseases with huge unmet medical needs. Advaccine is also developing a series of cancer vaccine candidates, covering viral-related oncology, neoantigen-based therapeutic vaccines and tumor-associated antigen therapeutic vaccines.

SOURCE: Advaccine

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