Abogen Biosciences Submits IND Application for Lyophilized RSV mRNA Vaccine

Dec 13, 2024 00:09 CST Updated 00:09

Abogen

Nucleic Acid Drug Developer

On December 11, 2024, according to the Center for Drug Evaluation of the National Medical Products Administration（CDE）Official website announcement,Abogen Biosciences("Abogen")Declared Freeze-Dried Respiratory Syncytial Virus（RSV）Clinical Trial Application for New mRNA Vaccine Accepted(Application Nos.: CXSL2400848, CXSL2400849, CXSL2400850), planning to conduct clinical trials for different age groups of the target population.

Source: CDE official website

RSV is a common respiratory infectious pathogen with high contagiousness and is widely prevalent globally. RSV infection is an important cause of death in infants under one year of age and a significant factor in respiratory infection-related deaths among the elderly. Additionally, individuals who have been infected with RSV may still be reinfected. Currently, there are no approved antiviral drugs specifically targeting RSV available for clinical use worldwide. Prevention of RSV has become a crucial strategy to counter its health threats, and vaccination for active immunization is an effective means to prevent severe RSV infections.

After decades of research and exploration, there are currently three RSV vaccines approved for marketing worldwide, which are recombinant protein vaccines from GSK and Pfizer.(Subunit)Vaccine AREXVY(Unit Price)And ABRYSVO(Divalent), as well as Moderna's mRNA vaccine mRESVIA(Unit Price)。Currently, no RSV vaccine products have been approved for marketing in China.

Progress of RSV Vaccines in China That Have Been Submitted for Clinical Trials

Since the 1960s, the development of pediatric RSV vaccines has been...Vaccine-Associated Enhanced Respiratory Disease（VAERD）And fell into a stagnant state. Thanks to the deconstruction of the RSV Pre-F protein, this issue has been alleviated. Currently, the clinical trials of RSV vaccines by GSK and Pfizer have also encounteredGuillain-Barré（Guillain-Barre）SyndromeCase, this is a disease where the immune system damages nerve cells, posing certain safety risks. The U.S. CDC has now requested two companies to continue conducting correlation studies.

Recently, multiple clinical trials targeting children have observed "RSV severe/very severe lower respiratory tract infections（LRTI）The imbalance in cases" presents clinical data similar to the situation that occurred in the 1960s. Therefore,FDA has suspended all current RSV candidate vaccine studies in the United States for children under 2 years old and for those aged 2 to 5 who have not been previously infected with RSV.

Allowing future pediatric studies on other non-live attenuated RSV vaccines,It is necessary to conduct an in-depth analysis of potential risks based on the technical pathway and/or antigen design of the vaccine, and properly address issues such as the potential interaction between RSV monoclonal antibodies and RSV vaccines. Therefore,Determine the future of RSV vaccines and their implementation across different age groupsBenefits of vaccination outweigh risksThe key still lies in solvingSafetyQuestion.

Source: Abogen,RNAScript

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