# US 12,275,949 B2 · High-transducing HSV vectors

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- Number: US 12,275,949 B2
- Document ID: US12275949B2
- Status: Granted
- Kind: B2
- Application number: 18/359,013
- Filed: 2023-07-26
- Published: 2024-05-16
- Granted: 2025-04-15
- Earliest claimed: 2016-03-25
- Assignees: PeriphaGen, Inc.
- Applicants: PeriphaGen, Inc.
- Inventors: David M. Krisky; James B. Wechuck; James R. Goss
- Web page: https://patentgrep.com/patent/US12275949B2

## CPC

- C12N 15/86: Viral vectors
- A61K 48/0025: {wherein the non-active part clearly interacts with the delivered nucleic acid}
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12N 2710/16621: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2710/16641: Use of virus, viral particle or viral elements as a vector
- C12N 2710/16643: viral genome or elements thereof as genetic vector
- C12N 2710/16662: by genetic engineering
- C12N 2830/008: cell type or tissue specific enhancer/promoter combination
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Disclosed herein are high transducing replication defective herpes simplex virus (HSV) vectors of McKrae strain.

## Claims

### Claim 1

A gene therapy vector comprising a replication-defective variant of herpes simplex virus (HSV) McKrae strain whose genome contains an alteration such that the variant fails to express a functional ICP4 protein comprising SEQ ID NO: 16, wherein the gene therapy vector is capable of expressing a payload in a cell susceptible to McKrae strain infection for at least 18 days.

### Claim 2 (depends on 1)

The gene therapy vector of claim 1, wherein the gene therapy vector comprises a neuron specific promoter.

### Claim 3 (depends on 2)

The gene therapy vector of claim 2, wherein the neuron specific promoter is a calcitonin gene-related peptide (CGRP) promoter.

### Claim 4 (depends on 1)

The gene therapy vector of claim 1, wherein the gene therapy vector comprises a human cytomegalovirus (HCMV) enhancer.

### Claim 5 (depends on 1)

The gene therapy vector of claim 1, wherein the gene therapy vector comprises a bovine growth hormone (BGH) polyadenylation signal.

### Claim 6 (depends on 1)

The gene therapy vector of claim 1, further comprising a nucleic acid that encodes a therapeutic polypeptide.

### Claim 7 (depends on 1)

The gene therapy vector of claim 1, wherein the functional ICP4 protein has an amino acid sequence of SEQ ID NO: 2.

### Claim 8 (depends on 1)

The gene therapy vector of claim 1, wherein the gene therapy vector is capable of expressing a payload in a cell susceptible to McKrae strain infection for at least 50 days.

### Claim 9 (depends on 1)

The gene therapy vector of claim 1, wherein the gene therapy vector is capable of expressing a payload in a cell susceptible to McKrae strain infection for at least 100 days.

### Claim 10 (depends on 1)

The gene therapy vector of claim 1, wherein the gene therapy vector is capable of producing in neurons a mean genome copy number of greater than 5,000 transcripts.

### Claim 11 (depends on 1)

The gene therapy vector of claim 1, wherein the gene therapy vector is capable of producing in neurons a mean genome copy number of greater than 10,000 transcripts.

### Claim 12 (depends on 1)

The gene therapy vector of claim 1, wherein the gene therapy vector is capable of producing in neurons a mean genome copy number of greater than 15,000 transcripts.

### Claim 13 (depends on 1)

A cell transduced with a gene therapy vector according to claim 1.

### Claim 14 (depends on 1)

A pharmaceutical composition comprising a gene therapy vector according to claim 1 and a pharmaceutically acceptable carrier.