	US 11,925,694 B2
	Coronavirus vaccine
Ugur Sahin, Mainz (DE); Alptekin Güler, Mainz (DE); Andreas Kuhn, Mainz (DE); Alexander Muik, Seeheim-Jugenheim (DE); Annette Vogel, Mainz (DE); Kerstin Walzer, Seeheim-Jugenheim (DE); Sonja Witzel, Bad Vilbel (DE); Stephanie Hein, Rüsselsheim (DE); and Özlem Türeci, Mainz (DE)
Assigned to BioNTech SE, Mainz (DE)
Filed by BioNTech SE, Mainz (DE)
Filed on Mar. 18, 2022, as Appl. No. 17/698,829.
Application 17/698,829 is a continuation of application No. PCT/EP2021/059947, filed on Apr. 16, 2021.
Claims priority of application No. PCT/EP2020/061239 (WO), filed on Apr. 22, 2020; application No. PCT/EP2020/066968 (WO), filed on Jun. 18, 2020; application No. PCT/EP2020/068174 (WO), filed on Jun. 26, 2020; application No. PCT/EP2020/069805 (WO), filed on Jul. 13, 2020; application No. PCT/EP2020/071733 (WO), filed on Jul. 31, 2020; application No. PCT/EP2020/071839 (WO), filed on Aug. 3, 2020; application No. PCT/EP2020/081544 (WO), filed on Nov. 9, 2020; application No. PCT/EP2020/081981 (WO), filed on Nov. 12, 2020; application No. PCT/EP2020/082601 (WO), filed on Nov. 18, 2020; application No. PCT/EP2020/082989 (WO), filed on Nov. 20, 2020; application No. PCT/EP2020/083435 (WO), filed on Nov. 25, 2020; application No. PCT/EP2020/084342 (WO), filed on Dec. 2, 2020; application No. PCT/EP2020/085145 (WO), filed on Dec. 8, 2020; application No. PCT/EP2020/085653 (WO), filed on Dec. 10, 2020; application No. PCT/EP2020/087844 (WO), filed on Dec. 23, 2020; application No. PCT/EP2020/050027 (WO), filed on Jan. 4, 2021; application No. PCT/EP2020/050874 (WO), filed on Jan. 15, 2021; application No. PCT/EP2020/050875 (WO), filed on Jan. 15, 2021; application No. PCT/EP2020/051772 (WO), filed on Jan. 26, 2021; application No. PCT/EP2020/052572 (WO), filed on Feb. 3, 2021; application No. PCT/EP2020/052716 (WO), filed on Feb. 4, 2021; and application No. PCT/EP2020/054622 (WO), filed on Feb. 24, 2021.
Prior Publication US 2023/0075979 A1, Mar. 9, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61P 31/14 (2006.01); A61K 9/00 (2006.01); A61K 9/127 (2006.01); A61K 9/51 (2006.01); A61K 31/7088 (2006.01); A61K 31/7105 (2006.01); A61K 31/711 (2006.01); A61K 31/7115 (2006.01); A61K 31/712 (2006.01); A61K 39/00 (2006.01); A61K 39/12 (2006.01); A61K 39/215 (2006.01); A61K 48/00 (2006.01); A61P 35/00 (2006.01); B82Y 5/00 (2011.01); C12N 7/00 (2006.01); C12N 15/11 (2006.01); C12N 15/67 (2006.01); C12N 15/88 (2006.01); C12P 19/34 (2006.01); A61K 38/00 (2006.01)

CPC A61K 48/0066 (2013.01) [A61K 9/0019 (2013.01); A61K 9/1271 (2013.01); A61K 9/5123 (2013.01); A61K 9/5146 (2013.01); A61K 31/7088 (2013.01); A61K 31/7105 (2013.01); A61K 31/711 (2013.01); A61K 31/7115 (2013.01); A61K 31/712 (2013.01); A61K 39/0011 (2013.01); A61K 39/12 (2013.01); A61K 39/215 (2013.01); A61K 48/0033 (2013.01); A61P 31/14 (2018.01); A61P 35/00 (2018.01); B82Y 5/00 (2013.01); C12N 7/00 (2013.01); C12N 15/11 (2013.01); C12N 15/67 (2013.01); C12N 15/88 (2013.01); C12P 19/34 (2013.01); A61K 38/00 (2013.01); A61K 2039/53 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01); A61K 2039/55555 (2013.01); C12N 2770/18022 (2013.01); C12N 2770/18034 (2013.01); C12N 2770/18071 (2013.01); C12N 2770/20034 (2013.01); C12N 2840/00 (2013.01)]

36 Claims

1. A pharmaceutical composition comprising an RNA wherein said RNA comprises, from a 5′ to 3′ direction:

(i) a 5′ UTR that comprises a human alpha-globin 5′-UTR;

(ii) a nucleotide sequence that is at least 90% identical to SEQ ID NO: 9, wherein said nucleotide sequence:

(a)includes modified uridines in place of uridines; and

(b) encodes a SARS-CoV-2 Spike (S) polypeptide that is at least 95% identical to SEQ ID NO: 7 and is prefusion stabilized in that it includes at least one proline substitution at position(s) corresponding to position(s) 986 and/or 987 in SEQ ID NO: 7; and

(iii) a 3′-UTR that comprises a first sequence from the amino terminal enhancer of split (AES) messenger RNA and a second sequence from the mitochondrial encoded 12S ribosomal RNA.