Compositions and methods for synthesizing 5′-Capped RNAS

Inventors

Hogrefe, Richard I.Lebedev, AlexandreMcCaffrey, Anton P.Shin, Dongwon

Assignees

Trilink Biotechnologies LLC

Interested in licensing this patent?

MTEC can help explore whether this patent might be available for licensing for your application.

Publication Number

US-10494399-B2

Patent

Publication Date

2019-12-03

Expiration Date


Abstract

Provided herein are methods and compositions for synthesizing 5′Capped RNAs wherein the initiating capped oligonucleotide primers have the general form m7Gppp[N2′Ome]n[N]m wherein m7G is N7-methylated guanosine or any guanosine analog, N is any natural, modified or unnatural nucleoside, “n” can be any integer from 0 to 4 and “m” can be an integer from 1 to 9.

Core Innovation

The disclosure describes a complex comprising an initiating capped oligonucleotide primer and a DNA template. The DNA template comprises a promoter region having a transcriptional start site with a first nucleotide at nucleotide position +1, a second nucleotide at nucleotide position +2, and a third nucleotide at nucleotide position +3, and the capped oligonucleotide primer is hybridized to the DNA template at least at nucleotide positions +1, +2, and +3.

The initiating capped oligonucleotide primer includes a structure in which B1, B2, and B3 are independently a natural, a modified, or an unnatural nucleoside base, and R1, R2, R3, and R4 are independently OH or O-methyl. The primer structure provides cap features associated with Cap 0, Cap 1, Cap 2, and TMG-cap-like features, including m7G and guanosine analogs, and optional 2′-O-methylated nucleosides.

The disclosure emphasizes that initiating capped oligonucleotide primers with the general form m7Gppp[N2′Ome]n[N]m and/or Formula I structures are used to improve initiation fidelity and capping efficiency/yield while reducing the need for post-transcriptional capping and 2′-O-methylation steps. The disclosure also reports compatibility with T7 transcription systems and provides example primer sequences and performance results using assays such as co-transcriptional capping efficiency via LC-MS and translation activity in cells.

Claims Coverage

The independent claim covers a complex defined by an initiating capped oligonucleotide primer and a DNA template promoter region with defined transcriptional start-site positions +1 to +3, with the primer hybridized at those positions. The claim language includes three inventive features: hybridization at +1, +2, and +3; configurable nucleoside base identity at B1 to B3; and OH or O-methyl substituent selection at R1 to R4.

Hybridized initiating capped oligonucleotide primer on +1 to +3 transcriptional start site

An initiating capped oligonucleotide primer is hybridized to the DNA template at least at nucleotide positions +1, +2, and +3, where the DNA template comprises a promoter region with a transcriptional start site having a first nucleotide at nucleotide position +1, a second nucleotide at nucleotide position +2, and a third nucleotide at nucleotide position +3.

Configurable nucleobase selection at B1 to B3 positions

The initiating capped oligonucleotide primer comprises a structure where B1, B2, and B3 are independently a natural, a modified, or an unnatural nucleoside base.

OH or O-methyl substituent selection at R1 to R4 positions

The initiating capped oligonucleotide primer comprises a structure where R1, R2, R3, and R4 are independently OH or O-methyl.

Across the independent claim and its refinements, the patent focuses on a complex in which a structured initiating capped oligonucleotide primer is hybridized to a DNA template promoter transcriptional start site at positions +1 to +3, while allowing defined variability in nucleoside base identity and substituent chemistry.

Stated Advantages

Reduces the need for post-transcriptional capping/2′-O-methylation steps.

Improves forward-orientation initiation fidelity.

Enhances capping efficiency and yield.

Provides compatibility with T7 transcription systems.

Documented Applications

Co-transcriptional capping efficiency measurement using LC-MS, including reporting improved capping efficiency for luciferase mRNA in cells.

Translation activity in cells is assessed using detectable markers/labels such as luciferase mRNA-related readouts.

Use of initiating capped oligonucleotide primers with T7 transcription systems for synthesis of 5′-capped RNAs.

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.