Patent ID: 11964012
Assignee: CUREVAC SE
Field: Pharmaceuticals (Chemistry)
Classification: CPC A  C | IPC A

Claim 22:
23. A pharmaceutical composition comprising:
(I) a purified mRNA comprising:
(a) a 5′ cap structure;
(b) a heterologous 5′ untranslated region (UTR);
(c) a coding sequence encoding a SARS-CoV-2 spike protein at least 95% identical to the amino acid sequence of SEQ ID NO: 10 that is a pre-fusion stabilized spike protein comprising: a proline at position 986, a proline at position 987, and a glycine at position 614 all relative to SEQ ID NO: 10, wherein the coding sequence is at least 95% identical to the RNA sequence of SEQ ID NO: 146; and
(d) a heterologous 3′ UTR, comprising a terminal poly(A) sequence of 30 to 200 adenosine nucleotides,

wherein 100% of the uracil positions in the mRNA are replaced with 1-methylpseudouridine; and
(II) at least one pharmaceutically acceptable carrier,, wherein the mRNA is complexed or associated with lipid nanoparticles (LNPs), said LNPs comprising:
(i) a cationic lipid component;
(ii) a neutral lipid component, comprising 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC);
(iii) a sterol component, comprising cholesterol; and
(iv) a PEG-lipid component,
wherein (i) to (iv) are in a molar ratio of about 20-60% cationic lipid component, 5-25% neutral lipid component, 25-55% sterol component, and 0.5-5% PEG-lipid component,
wherein the LNPs have a mean diameter of from about 50 nm to about 200 nm as determined by dynamic light scattering and a polydispersity index (PDI) of 0.1 to 0.5 as determined by dynamic light scattering.