US 12,121,592 B2
Lipid nanoparticle compositions and methods for mRNA delivery
Frank DeRosa, Cambridge, MA (US); Braydon Charles Guild, Cambridge, MA (US); and Michael Heartlein, Cambridge, MA (US)
Assigned to Translate Bio, Inc., Cambridge, MA (US)
Filed by Translate Bio, Inc., Waltham, MA (US)
Filed on Jun. 3, 2022, as Appl. No. 17/832,196.
Application 17/832,196 is a division of application No. 17/558,310, filed on Dec. 21, 2021.
Application 17/558,310 is a division of application No. 17/509,674, filed on Oct. 25, 2021, granted, now 11,291,734, issued on Apr. 5, 2022.
Application 17/509,674 is a division of application No. 17/341,016, filed on Jun. 7, 2021, granted, now 11,185,595, issued on Nov. 30, 2021.
Application 17/341,016 is a division of application No. 17/099,462, filed on Nov. 16, 2020, granted, now 11,052,159, issued on Jul. 6, 2021.
Application 17/099,462 is a division of application No. 16/931,231, filed on Jul. 16, 2020, granted, now 10,888,626, issued on Jan. 12, 2021.
Application 16/931,231 is a division of application No. 16/681,565, filed on Nov. 12, 2019, abandoned.
Application 16/681,565 is a division of application No. 16/502,672, filed on Jul. 3, 2019, granted, now 10,507,249, issued on Dec. 17, 2019.
Application 16/502,672 is a division of application No. 16/286,400, filed on Feb. 26, 2019, granted, now 10,350,303, issued on Jul. 16, 2019.
Application 16/286,400 is a division of application No. 16/233,031, filed on Dec. 26, 2018, granted, now 10,413,618, issued on Sep. 17, 2019.
Application 16/233,031 is a division of application No. 15/482,117, filed on Apr. 7, 2017, granted, now 10,238,754, issued on Mar. 26, 2019.
Application 15/482,117 is a division of application No. 14/124,608, abandoned, previously published as PCT/US2012/041724, filed on Jun. 8, 2012.
Claims priority of provisional application 61/494,881, filed on Jun. 8, 2011.
Prior Publication US 2022/0378939 A1, Dec. 1, 2022
Int. Cl. A61K 48/00 (2006.01); A61K 9/00 (2006.01); A61K 9/127 (2006.01); A61K 9/51 (2006.01); A61K 31/713 (2006.01); A61K 38/18 (2006.01); A61K 38/47 (2006.01); A61K 38/48 (2006.01); A61K 38/57 (2006.01); C07K 14/505 (2006.01); C07K 14/81 (2006.01); C12N 9/40 (2006.01); C12N 9/64 (2006.01); C12N 15/52 (2006.01); C12N 15/85 (2006.01)
CPC A61K 48/0008 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0073 (2013.01); A61K 9/1271 (2013.01); A61K 9/1272 (2013.01); A61K 9/5123 (2013.01); A61K 31/713 (2013.01); A61K 38/1816 (2013.01); A61K 38/47 (2013.01); A61K 38/4846 (2013.01); A61K 38/57 (2013.01); A61K 48/0075 (2013.01); A61K 48/0091 (2013.01); C07K 14/505 (2013.01); C07K 14/8125 (2013.01); C12N 9/2465 (2013.01); C12N 9/644 (2013.01); C12N 15/52 (2013.01); C12N 15/85 (2013.01); C12Y 302/01022 (2013.01); C12Y 304/21022 (2013.01); A61K 48/00 (2013.01)] 19 Claims
 
1. A composition comprising: a first messenger RNA (mRNA) encoding a protein or peptide and a second mRNA encoding a protein or peptide, wherein the first mRNA and the second mRNA are encapsulated within a lipid nanoparticle,
wherein the lipid nanoparticle has a size less than 150 nm and comprises:
(i) a PEG-modified lipids at a molar ratio of greater than 1% of the total lipids in the lipid nanoparticle,
(ii) a cationic lipids at a molar ratio of greater than 10% of the total lipids in the lipid nanoparticle,
(iii) a non-cationic lipids at a molar ratio of greater than 5% of the total lipids in the lipid nanoparticle, and
(iv) cholesterol at a molar ratio of greater than 10% of the total lipids in the lipid nanoparticle.