For Veterinary Oncologists
Personalised Neoantigen mRNA Vaccines for Your Canine Patients
A personalised cancer vaccine, prescribed under your clinical authority, manufactured by a European CDMO, delivered to your practice. We handle the pipeline. You handle the patient.
A Different Conversation With Your Clients
For decades, the conversation about advanced canine cancer has ended the same way: surgery, chemotherapy, radiation — and when those run out, palliative care. You know it. Your clients know it. The conversation is exhausting because there is rarely good news at the end.
Personalised mRNA cancer vaccines change that conversation. They give you a treatment option that did not exist a year ago — based on the same science showing 49% recurrence reduction in human melanoma trials, adapted for dogs and validated against published canine cancer datasets. You can now offer something real when conventional options have been exhausted.
This page explains how it works, what's required from you, and how to refer your first patient.
The Computational and Manufacturing Pipeline
Every step uses established tools from human precision oncology, adapted for canine genomics. The pipeline is validated against published canine cancer datasets with known driver mutations.
Sequencing and Alignment
- Input
- Tumour biopsy (fresh frozen preferred, FFPE acceptable) + matched normal (blood)
- Sequencing
- Tumour-normal whole-exome sequencing, >100x tumour / >50x normal
- RNA-seq
- Tumour RNA-seq when tissue available (strongly recommended)
- Alignment
- BWA-MEM to CanFam3.1
- QC
- FastQC, coverage depth, duplication rate, contamination screening
Variant Calling and Annotation
- Variant calling
- Mutect2 + Strelka2 + VarScan2, consensus ≥2/3 callers
- Annotation
- Ensembl VEP (species-specific)
- Germline filtering
- DoGSD + Dog10K (28M SNVs, 186 genomes) for breed-specific polymorphism removal
- TMB calculation
- Tumour mutation burden per megabase; flagged if below viable threshold
- Tumour purity
- Estimated from sequencing data; cases below 20% flagged for re-biopsy consideration
MHC Typing
- Method
- DLA allele assignment from germline WES data
- Target
- DLA-88 class I alleles (primary), class II where data available
- Breed reference
- Known breed-DLA frequency distributions used for validation
- Limitation
- Canine DLA allele databases are less comprehensive than human HLA. Mixed-breed animals may have alleles with limited binding prediction training data. This is flagged per case.
Neoantigen Prediction and Selection
- Prediction engine
- pVACseq + NetMHCpan-4.1
- Binding stability
- NetMHCstab
- Cleavage prediction
- NetChop
- Fusion detection
- NeoFuse (from RNA-seq)
- Self-similarity
- BLAST against species reference proteome (UniProt)
- Immunogenicity
- PRIME / BigMHC scoring
- Binding affinity
- <500nM
- Expression validation
- Mutant allele confirmed in RNA-seq
- Clonality
- Clonal variants prioritised over subclonal
- Self-similarity
- Filtered against normal proteome
- Target count
- 15–20 neoantigens per construct
Selection criteria
Polyepitope Construct
- Architecture
- Ubmut (G76V) — [25-mer epitope] — AAY — [25-mer epitope] — …
- N-terminus
- Mutant ubiquitin tag for enhanced proteasomal processing
- Epitope length
- 25-mer centred on mutation (12 flanking residues each side)
- Linkers
- AAY (promotes MHC-I presentation)
- Signal peptide
- None (cytoplasmic retention for MHC-I presentation to CD8+ T cells)
- Typical length
- 600–800 amino acids (15–20 epitopes)
mRNA and LNP Specifications
- Cap structure
- Cap 1
- Modified nucleotides
- N1-methylpseudouridine (m1Ψ)
- Poly(A) tail
- 120 nucleotides
- Codon optimisation
- Species-specific
- UTRs
- Optimised for target species expression
- LNP formulation
- SM102 ionisable lipid
- Quantity
- 1 mg (preclinical/research grade)
- Purification
- HPLC / Oligo dT
- QC
- mRNA integrity, purity (A260/280), LNP size (DLS), encapsulation efficiency (RiboGreen), endotoxin (LAL)
Evidence Base
The scientific foundation rests on human clinical trial data — the most rigorous evidence available for personalised mRNA cancer vaccines.
Moderna/Merck — mRNA-4157/V940
Indication: Resected high-risk melanoma (adjuvant)
Result: 49% reduction in recurrence or death at 5-year follow-up vs pembrolizumab alone
Phase III ongoing
BioNTech — autogene cevumeran
Indication: Resected pancreatic ductal adenocarcinoma
Result: 50% immune response rate; responders showed dramatically improved recurrence-free survival at 3.2 years
Phase II
BioNTech — individualised neoantigen vaccine
Indication: Triple-negative breast cancer
Result: 11 of 14 patients disease-free after >6 years
Phase I long-term follow-up
NCI Comparative Oncology Program
Indication: Cross-species validation
Result: Dogs validated as translational models for human cancer — shared oncogenes (TP53, PIK3CA, BRAF), similar tumour microenvironment, comparable mutation landscapes
Ongoing programme
More than 150 personalised mRNA cancer vaccine trials are underway in humans across 20+ cancer types. The first regulatory approvals are expected in 2027–2028. The translational bridge to companion animals is short: the mRNA platform, LNP delivery, and neoantigen prediction tools are species-agnostic. The adaptation lies in species-specific reference genomes, MHC allele databases, and germline variant filtering.
Regulatory Framework
Each vaccine is manufactured as a Formula magistralis under Article 9(2)(a) of the Swiss Therapeutic Products Act (Heilmittelgesetz, HMG). A medicinal product manufactured on the basis of a veterinary prescription for a specific animal is exempt from marketing authorisation.
In practice: you prescribe the vaccine for your patient under your clinical authority. It is manufactured by an authorised facility to your prescription. No Swissmedic product approval is required. Each vaccine is a single-patient preparation — the regulatory framework that has always governed veterinary compounding.
This pathway is being confirmed by formal legal opinion for mRNA constructs specifically. For veterinarians outside Switzerland, parallel frameworks exist: the UK and the Netherlands both have pragmatic veterinary compassionate use and compounding provisions. We can advise on the applicable framework for your jurisdiction.
Multimodal Protocols
In human trials, personalised mRNA vaccines show their strongest results in combination with checkpoint inhibitors — drugs that release the brakes on the immune system. The Moderna/Merck melanoma data is vaccine plus pembrolizumab.
Gilvetmab, a canine anti-PD-1 monoclonal antibody from Merck Animal Health, has received a conditional USDA licence — the first veterinary checkpoint inhibitor. Combination with a personalised mRNA vaccine could significantly improve response rates, mirroring the human paradigm.
Tyrosine kinase inhibitors (toceranib, masitinib) and conventional chemotherapy remain relevant in multimodal protocols depending on tumour type and stage. Treatment protocols are developed collaboratively with you — we provide the vaccine and the genomic data, you determine the optimal treatment plan for your patient.
Your Role in the Pipeline
Patient selection and owner consultation
Assess candidacy based on tumour type, stage, prior treatments, and overall condition. We provide patient selection guidance based on tumour mutation burden thresholds and cancer type suitability. Discuss realistic expectations with the owner — we supply data-backed talking points.
Tumour biopsy and sample collection
Collect tumour tissue (fresh frozen preferred; FFPE acceptable with known quality trade-offs) and matched normal tissue (EDTA blood). Minimum tumour tissue: 200mg. We provide sample collection kits, labelling instructions, and coordinated shipping to the sequencing laboratory.
Review neoantigen analysis
You receive a summary report of the genomic analysis: mutations identified, neoantigens selected, DLA typing, tumour mutation burden, and predicted response likelihood. You approve the vaccine design before manufacturing begins.
Prescribe under your clinical authority
Prescribe the personalised vaccine for your specific patient under the Formula magistralis framework (Switzerland) or applicable compassionate use provision. The prescription authorises the CDMO to manufacture.
Administer and monitor
The vaccine arrives at your practice under cold chain (dry ice, -20°C/-80°C). Administer per the agreed protocol — typically intramuscular or intradermal. Follow-up imaging at 4, 8, and 12 weeks using veterinary RECIST-adapted criteria. We provide standardised response assessment templates.
Share outcome data
Anonymised outcome data — tumour measurements, response classification, adverse events, quality of life assessments — feeds the comparative oncology dataset. This data improves neoantigen prediction for all future patients and contributes to peer-reviewed publication.
Patient Selection
Not every patient is a good candidate. The following guidance is based on human clinical trial data and will be refined as veterinary outcome data accumulates.
Tumour stage
Favourable: Localised; post-surgical with minimal residual disease
Unfavourable: Widespread metastatic; large established tumour burden
Tumour mutation burden
Favourable: High TMB (>10 mutations/Mb)
Unfavourable: Very low TMB (<3 mutations/Mb); few targetable neoantigens
Cancer type
Favourable: Melanoma, mast cell tumours, carcinomas, osteosarcoma
Unfavourable: Tumours with inherent immune evasion; haematological cancers (limited data)
Prior treatment
Favourable: Post-surgical adjuvant; failed conventional therapy
Unfavourable: Heavily immunosuppressed from prior treatment
Immune status
Favourable: Intact immune function
Unfavourable: Severe immune compromise; concurrent immunosuppressive therapy
DLA type
Favourable: Known DLA alleles with NetMHCpan training data
Unfavourable: Rare or uncharacterised DLA alleles (prediction confidence lower)
When the genomic analysis indicates low likelihood of benefit — for example, tumour mutation burden too low to generate viable targets — we flag this before manufacturing. No vaccine is manufactured without your approval of the neoantigen analysis.
Refer a Patient or Discuss the Pipeline
We welcome conversations with veterinary oncologists interested in offering personalised mRNA vaccines to their patients. No commitment required — start with a conversation about a specific case or about the pipeline in general.
Response within 48 hours. We can arrange a video call to walk through the pipeline and discuss a specific case.