Clearance Issued to Initiate Clinical Studies with a Next Generation mRNA Vaccine Against Omicron SARS-CoV-2 Virus

Sorrento Therapeutics, Inc. announced today it received clearance from the U.S. FDA to initiate clinical trials with STI-1557, its next-generation mRNA vaccine against SARS-CoV-2 Omicron variants.

This mRNA vaccine candidate 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.

The modification was introduced to prevent the leakage of the 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 the administration of the current FDA-approved mRNA vaccines.

The mRNA is encapsulated in a Sorrento proprietary lipid nanoparticle formulation to protect mRNAs from degradation and enable the potent translation of the S protein in host cells after intramuscular delivery, thus inducing an adaptive immune response.

The preclinical work that supported this investigational new drug application was published online in Molecular Therapy Nucleic Acids on November 3, 2022, a Cell Press partner journal, and will appear in the December 2022 print issue.

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