Sorrento Therapeutics has Received FDA Clearance to Initiate Clinical Trials with a Next Generation mRNA (STI-1557) Vaccine Against Omicron SARS-CoV-2 Virus

• Modified mRNA sequence of the Spike protein prevents cleavage of the expressed protein, which may potentially result in a cleaner safety profile.
• Pre-clinical data supporting the investigational new drug application has been published in Molecular Therapy Nucleic Acids, a Cell Press Journal (https://www.cell.com/molecular-therapy-family/nucleic-acids/fulltext/S ...22)00287-6).
• If approved, this vaccine may provide an important alternative to the vaccines in the U.S. and enable improved access globally in countries like Mexico, Brazil, and China, where mRNA-based vaccines or vaccine boosters are not readily available.
• Sorrento’s mRNA-based next generation vaccine platform can potentially be adapted rapidly to ever-emerging SARS-CoV-2 variants of concern and useful for other preventive and therapeutic applications to cancer, metabolic and autoimmune diseases.
• In addition to intramuscular (IM) injections, future studies of the next generation mRNA-based vaccine candidates will be evaluated for administration with the Sofusa MuVaxx^TM lymphatic delivery device, which has demonstrated in preclinical models the potential to improve immune response with 10% of the dose required vs. IM injection. The results were published in Journal of Molecular Cell Biology (JMCB) (https://academic.oup.com/jmcb/advance-article/doi/10.1093/jmcb/mjac041 ...).
  

SAN DIEGO, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") has received clearance from the US FDA to initiate clinical trials with STI-1557, its next generation mRNA vaccine against SARS-CoV-2 Omicron variants. This mRNA vaccine incorporates a mutation in the furin cleavage site that prevents the S1 subunit cleavage from the spike protein from anchoring on the muscle cell membrane. This modification was introduced to prevent the leakage of S1 subunit from the expressed spike protein (S protein) into the blood circulation, which is known in part to potentially cause undesirable side effects in vital organ tissues following administration of the current FDA-approved mRNA vaccines. The mRNA is encapsulated in a Sorrento proprietary lipid nanoparticle formulation (LNP) to protect mRNAs from degradation and enable potent translation of the S protein in host cells after intramuscular (IM) delivery, thus inducing an adaptive immune response.