# US 2026/0174705 A1 · Cancer vaccines

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- Number: US 2026/0174705 A1
- Document ID: US20260174705A1
- Status: Published application
- Kind: A1
- Application number: 19/532,963
- Filed: 2026-02-06
- Published: 2026-06-25
- Earliest claimed: 2015-10-22
- Assignees: ModernaTX, Inc.
- Applicants: ModernaTX, Inc.
- Inventors: Nicholas Valiante; Tal Zaks; Eric Yi-Chun Huang
- Web page: https://patentgrep.com/patent/US20260174705A1

## CPC

- A61K 9/5123: {Organic compounds, e.g. fats, sugars}
- A61K 9/10: Dispersions; Emulsions
- A61K 39/0011: {Cancer antigens}
- A61K 39/001114: {CD74, Ii, MHC class II invariant chain or MHC class II gamma chain}
- A61P 35/00: Antineoplastic agents
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55588: {Adjuvants of undefined constitution}
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The disclosure relates to cancer ribonucleic acid (RNA) vaccines, as well as methods of using the vaccines and compositions comprising the vaccines.

## Claims

### Claim 1

A method of treating a cancer in a patient, comprising administering to the patient a personalized mRNA cancer vaccine, comprising:
an mRNA having an open reading frame (ORF) encoding 5-50 peptide epitopes arranged in a head-to-tail formation, wherein the peptide epitopes are connected to one another directly or via a linker; and
a lipid nanoparticle (LNP) comprising 5-25 mol % non-cationic lipid, 25-55 mol % sterol, 0.5-15 mol % polyethylene glycol (PEG)-modified lipid, and 20-60 mol % of an ionizable cationic lipid of Compound 25:
wherein the mRNA cancer vaccine is prepared by a process comprising:
(a) identifying neoepitopes that are expressed in a tumor sample from a patient but not expressed in a normal tissue of the patient;
(b) selecting peptide epitopes to be encoded by the mRNA ORF that have the following characteristics:
(i) the peptide epitopes are selected from the identified neoepitopes;
(ii) the peptide epitopes lack self reactivity;
(iii) each peptide epitope contains at least one of the following types of mutations: an insertion, a deletion, a substitution, and a frameshift mutation; and
(iv) at least one of the peptide epitopes is an MHC class I epitope and at least one of the peptide epitopes is an MHC class II epitope;
(c) preparing the mRNA, wherein the mRNA is modified with N1-methylpseudouridine throughout the entire sequence; and
(d) formulating the mRNA with the LNP.

### Claim 2 (depends on 1)

The method of claim 1, wherein one or more of the peptide epitopes comprises a recurrent polymorphism present in a mutanome of the patient.

### Claim 3 (depends on 1)

The method of claim 1, wherein one or more of the peptide epitopes comprises a recurrent somatic cancer mutation in p53.

### Claim 4 (depends on 1)

The method of claim 1, wherein each peptide epitope is 9-29 amino acids in length.

### Claim 5 (depends on 1)

The method of claim 1, wherein the ORF encodes 20-50 peptide epitopes.

### Claim 6 (depends on 1)

The method of claim 1, wherein at least 30% of the peptide epitopes are MHC class I epitopes.

### Claim 7 (depends on 1)

The method of claim 1, wherein at least 50% of the peptide epitopes are MHC class I epitopes.

### Claim 8 (depends on 1)

The method of claim 1, wherein one or more of the peptide epitopes exhibit T cell reactivity.

### Claim 9 (depends on 1)

The method of claim 1, wherein at least 50% of the peptide epitopes have a predicted binding affinity for HLA-A, HLA-B and/or DRB1.

### Claim 10 (depends on 1)

The method of claim 1, wherein the peptide epitopes are arranged to minimize pseudo-epitopes.

### Claim 11 (depends on 1)

The method of claim 1, wherein, in the lipid nanoparticle:
the neutral lipid is selected from the group consisting of disteroylphosphatidyl choline (DSPC), 1-palmitoyl-2-oleoyl phosphatidylcholine (POPC), dipalmitoylphosphatidylcholine (DPPC), dioleoyl phosphatidylethanolamine (DOPE) and sphingomyelin (SM); and
the PEG-modified lipid is selected from the group consisting of PEG-c-DOMG (R-3-[(ω-methoxy-poly(ethyleneglycol)2000)carbamoyl)]-1,2-dimyristyloxypropyl-3-amine), PEG-DSG (1,2-distearoyl-sn-glycerol, methoxypolyethylene glycol), PEG-DMG (polyethylene glycol-1,2-dimyristoyl-sn-glycerol), PEG-DPG (1,2-dipalmitoyl-sn-glycerol, methoxypolyethylene glycol), and PEG-CDMA (poly(ethyleneglycol)-carbamoyl-1,2-dimyristyloxypropylamine).

### Claim 12 (depends on 1)

The method of claim 1, wherein the LNP comprises about 50 mol % ionizable cationic lipid of Compound 25, about 10 mol % DSPC, about 38.5 mol % cholesterol, and about 1.5 mol % PEG2000-DMG.

### Claim 13 (depends on 12)

The method of claim 12, wherein the mRNA has the following features: (a) a poly A tail; (b) a 5′ terminal cap; (c) a 5′ untranslated region (UTR); and (d) a 3′ UTR.

### Claim 14 (depends on 13)

The method of claim 13, wherein:
(i) each peptide epitope is 9-29 amino acids in length;
(ii) the ORF encodes 25-35 peptide epitopes; and
(iii) at least 30% of the peptide epitopes are MHC class I epitopes.

### Claim 15 (depends on 1)

The method of claim 1, wherein the mRNA cancer vaccine is administered intramuscularly.

### Claim 16 (depends on 1)

The method of claim 1, wherein the mRNA cancer vaccine is administered once every three weeks for multiple cycles.

### Claim 17 (depends on 1)

The method of claim 1, wherein the method further comprising administering an immune checkpoint inhibitor.

### Claim 18 (depends on 17)

The method of claim 17, wherein the immune checkpoint inhibitor is an anti-PD-1 antibody.

### Claim 19 (depends on 17)

The method of claim 17, wherein the immune checkpoint inhibitor is pembrolizumab.

### Claim 20 (depends on 1)

The method of claim 1, wherein:
the LNP comprises about 50 mol % ionizable cationic lipid of Compound 25, about 10 mol % DSPC, about 38.5 mol % cholesterol, and about 1.5 mol % PEG2000-DMG;
the mRNA has the following features: (a) a poly A tail; (b) a 5′ terminal cap; (c) a 5′ untranslated region (UTR); and (d) a 3′ UTR;
each peptide epitope is 9-29 amino acids in length;
the ORF encodes 25-35 peptide epitopes; and
at least 30% of the peptide epitopes are MHC class I epitopes.

### Claim 21 (depends on 20)

The method of claim 20, further comprising administering pembrolizumab to the patient.

### Claim 22

A method of treating a cancer in a patient, comprising administering to the patient a personalized mRNA cancer vaccine, comprising:
an mRNA having an open reading frame (ORF) encoding 5-50 peptide epitopes arranged in a head-to-tail formation, wherein the peptide epitopes are connected to one another directly or via a linker; and
a lipid nanoparticle (LNP) comprising about 50 mol % ionizable cationic lipid of Compound 25, about 10 mol % DSPC, about 38.5 mol % cholesterol, and about 1.5 mol % PEG2000-DMG,
wherein the mRNA cancer vaccine is prepared by a process comprising:
(a) identifying a patient specific mutanome;
(b) selecting peptide epitopes to be encoded by the mRNA ORF that have the following characteristics:
(i) the peptide epitopes are selected from the patient specific mutanome;
(ii) the peptide epitopes lack self reactivity;
(iii) each peptide epitope contains at least one of the following types of mutations: an insertion, a deletion, a substitution, and a frameshift mutation; and
(iv) at least one of the peptide epitopes is an MHC class I epitope and at least one of the peptide epitopes is an MHC class II epitope;
(c) preparing the mRNA, wherein the ORF is modified with N1-methylpseudouridine throughout the entire sequence; and
(d) formulating the mRNA with the LNP.

### Claim 23 (depends on 22)

The method of claim 22, wherein:
(i) the mRNA has the following features: (a) a poly A tail; (b) a 5′ terminal cap; (c) a 5′ untranslated region (UTR); and (d) a 3′ UTR;
(ii) each peptide epitope is 9-29 amino acids in length;
(iii) the ORF encodes 25-35 peptide epitopes; and
(iv) at least 30% of the peptide epitopes are MHC class I epitopes.

### Claim 24 (depends on 23)

The method of claim 23, further comprising administering pembrolizumab to the patient.