US 12,312,376 B2
Therapeutic double stranded RNA and methods for producing the same
Thomas K. Equels, Ocala, FL (US); Vishwajeetsinh M. Atodaria, North Brunswick, NJ (US); Victoria G. Scott, Langhorne, PA (US); David R. Strayer, Bryn Mawr, PA (US); and Peter W. Rodino, Fort Myers, FL (US)
Assigned to AIM ImmunoTech Inc., Ocala, FL (US)
Appl. No. 17/773,545
Filed by AIM ImmunoTech Inc., Ocala, FL (US)
PCT Filed Jan. 25, 2021, PCT No. PCT/US2021/014967
§ 371(c)(1), (2) Date Apr. 29, 2022,
PCT Pub. No. WO2021/151099, PCT Pub. Date Jul. 29, 2021.
Claims priority of provisional application 63/125,950, filed on Dec. 15, 2020.
Claims priority of provisional application 63/092,432, filed on Oct. 15, 2020.
Claims priority of provisional application 63/016,960, filed on Apr. 28, 2020.
Claims priority of provisional application 62/982,641, filed on Feb. 27, 2020.
Claims priority of provisional application 62/971,199, filed on Feb. 6, 2020.
Claims priority of provisional application 62/965,713, filed on Jan. 24, 2020.
Prior Publication US 2022/0389050 A1, Dec. 8, 2022
Int. Cl. C07H 21/02 (2006.01); A61K 31/713 (2006.01)
CPC C07H 21/02 (2013.01) [A61K 31/713 (2013.01)] 8 Claims
 
1. A method for synthesis of a therapeutic double-stranded RNA (tdsRNA), comprising:
a) synthesizing a first single-stranded RNA (first ssRNA) in a first synthesis reaction with PNPase as the only RNA polymerase;
b) synthesizing a second single-stranded RNA (second ssRNA) in a second synthesis reaction with PNPase as the only RNA polymerase; and
c) hybridizing the first ssRNA with the second ssRNA to form the tdsRNA;
wherein step a) and step b) are performed in any order,
wherein the first synthesis reaction comprises inosine diphosphate (rIDP) as the only free ribonucleotide,
wherein the second synthesis reaction comprises cytidine diphosphate (rCDP) and uridine diphosphate (rUDP) as the only two free ribonucleotides, and
wherein the method is performed without lyophilization.