Press Release 2024. 11. 13
November 13, 2024, Hong Kong, Shenzhen, Nanjing, Boston—Innorna, a clinical-stage biotechnology company pioneering its proprietary lipid nanoparticle (LNP) technology to develop novel mRNA vaccines and therapeutics, today announced the first participant has been dosed in the Phase I clinical trial of its investigational bivalent respiratory syncytial virus (RSV) mRNA vaccine IN006 in China. This clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of IN006 in healthy adult participants.
IN006, the world's first bivalent RSV mRNA vaccine, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) in January 2024 and from the China National Medical Products Administration in June 2024. The first participant dosed (FPD) marks another significant milestone, positioning IN006 as the first domestically developed RSV vaccine into officiall commencement of clinical trial in China.
About Respiratory Syncytial Virus (RSV) and IN006
RSV is a highly contagious respiratory virus that can cause repeated infections. In the general population, RSV infection presents similarly to the common cold; however, in the elderly, infants, and those with immune deficiencies, RSV can lead to severe lower respiratory tract diseases, thus imposing a significant health and social burden. In 2019, there were 33 million cases of acute lower respiratory infections caused by RSV in children under five worldwide, leading to 3.6 million hospitalizations and 101,000 deaths. The rates of intensive care requirement and mortality in the elderly hospitalized due to RSV-related infections can be two to three times higher than those hospitalized due to influenza or COVID-19 infections. RSV can cause outbreaks in community and hospital settings. Currently, only supportive and symptomatic treatments are available in clinical setting and there is no effective antiviral therapies. Vaccination for active immunization is a key measure to prevent severe manifestation and reduce mortality associated with RSV.
After decades of research and development, there are three RSV vaccines approved to market by U.S. FDA recently: GSK and Pfizer's recombinant protein (subunit) vaccines AREXVY (monovalent) and ABRYSVO (bivalent), and Moderna's mRNA vaccine mRESVIA (monovalent). To date, no RSV vaccine has been approved in China.
IN006, utilizing Innorna's proprietary pre-fusion F protein design and LNP delivery system, targets both subgroup A and subgroup B of RSV. RSV A and RSV B often laternate or co-circulate during different epidemic seasons. Compared with the monovalent RSV vaccines which may induce compromised cross-protection against the non-vaccine subgroup, bivalent vaccines may provide broader spectrum of protection from both RSV A and RSV B. In preclinical studies, IN006 has demonstrated a well-tolerated safety profile and a high potency to induce immune response and protect animals from viral challenge.
About Innorna
Founded in 2019, Innorna focuses on developing best-in-class LNP delivery technology and advancing innovative RNA therapies to address unmet medical needs globally. Innorna has built a diversity-oriented lipid library (DOLL) of over 5,000 ionizable lipids, which can be applied in various modalities or scenarios, including mRNA vaccines, protein replacement therapies, in vivo genome editing therapies, in vivo CAR therapies, etc. Innorna’s comprehensive R&D capability fully supports the end-to-end process of innovative therapies for internal development and external collaboration partners, from discovery to clinical development. Innorna has developed an extensive global patent portfolio and filed over 40 patent applications regarding the innovation of LNP and mRNA technology.
Innorna has built extensive internal R&D pipelines for infectious and rare diseases based on its proprietary technology platform. In addition, the company has established partnerships with pharma and biotech companies to explore the technology's potential in broader therapeutic areas. Since its establishment five years ago, Innorna has been widely recognized by the investment community and industry. It has won many awards, including MIT Technology Review's Global 50 Smartest Companies (2020 and 2022) and Fortune China's Most Socially Influential Startups.
At Innorna, we value INNOVATION, INTEGRITY, EFFICIENCY, and OPENNESS. Innorna is committed to exploring the frontier of mRNA application based on platform technologies and leading the revolutionary step toward expanding the clinical application of mRNA in various therapeutic approaches to fulfill the unmet medical needs of patients worldwide!
Please visit the Innorna website at www.innorna.com for more information.
