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