Onquell
Onquell

Veterinary oncology · Targeted biologics

Strike the tumor. Spare the companion.

Onquell builds purpose-built targeted cancer medicines for dogs. Our lead program, ONQ-001, is a caninized antibody-drug conjugate built around an AI-generated antibody discovery strategy — compressing the time and cost of traditional antibody discovery while delivering a potent payload to the tumor and leaving healthy tissue alone.

1 in 4dogs develops cancer in its lifetime
4drugs FDA-approved to treat cancer in dogs, and none for cats
0antibody-drug conjugates approved for companion animals
15+FDA-approved human ADCs, a modality now reaching dogs

Our goal

Modern cancer medicine, built for dogs

Our mission is to bring the precision of modern human oncology to the dogs and families who have gone without it.

The gap

Few purpose-built options

Most canine cancer care still depends on drugs developed for people. Patentable medicines designed for dogs remain scarce, and none use the targeted modalities now reshaping human oncology.

The barrier

Economics, not biology

Development costs are high relative to veterinary indications, and clinical sites see limited caseload per tumor type. The science is compelling; the business model has held it back.

Our answer

A disciplined, targeted program

We adapt a proven human modality to a de novo canine antibody and run each stage of development where it is most capital-efficient, to FDA standards.

For veterinary oncologists

An off-the-shelf, labeled targeted therapy that any oncology practice can prescribe, with biomarker selection to identify the dogs most likely to benefit.

For pet owners

Treatment options designed around canine biology and tolerability, with the goal of meaningful time and quality of life for their companion.

Our position

The right modality, at the right moment

Veterinary oncology is ready for an off-the-shelf targeted biologic, and the tools to build one already exist. Onquell sits where those two trends meet.

Why now

A mature modality

Established linker-payload chemistries, analytical methods and ADC-experienced manufacturing capacity can be adapted rather than invented.

Encouraging canine evidence

Published studies support antibody-drug conjugates as active against solid tumors in dogs, outperforming non-conjugated antibodies in canine tumor models.

Regulatory and market readiness

FDA conditional approval has already carried canine cancer drugs to full approval, and owners have shown they will choose advanced biologics for their pets.

How we differ

Approach Targeted Off-the-shelf Labeled for dogs
Onquell ADC Yes Yes Planned
Conventional chemotherapy No Yes Mostly off-label
Patient-specific vaccines and cell therapies Yes No Varies
Repurposed human drugs Varies Yes No

A batch-manufactured product that is stored, shipped and prescribed like any other medicine, with no patient-specific manufacturing or pre-surgery tissue collection.

Urothelial carcinoma Anal sac gland carcinoma Mammary gland tumor Primary lung carcinoma Osteosarcoma Prostate cancer

Our indication sequence. We start with our highest-confidence indication where no therapy is approved, then expand.

Our technology

ONQ-001: an AI-designed, caninized antibody-drug conjugate

An ADC links a tumor-seeking antibody to a potent cytotoxic payload. We generate that antibody computationally, using an AI-driven discovery strategy that identifies high-affinity, internalizing candidates in a fraction of the time and cost of a traditional hybridoma campaign.

How an ADC reaches its target

Target engagement is necessary but not sufficient. Every step below has to work, and we design for each one.

  1. Target antigen on the tumor cellA tumor marker identifies the cancer cell
  2. Antibody bindingOur AI-generated canine antibody locks on
  3. InternalizationThe cell draws the conjugate inside
  4. Lysosomal traffickingIt is routed to the lysosome
  5. Payload releaseThe linker frees the payload
  6. Tumor-cell deathThe cancer cell is destroyed

Five levers we control to widen the therapeutic window

Antibody

An AI-generated, de novo canine antibody candidate, selected computationally for affinity, epitope and internalization on a caninized Fc — compressing discovery time and cost versus traditional campaigns.

Linker

Cleavable designs for bystander killing versus non-cleavable designs for systemic stability.

Payload

Chosen to balance potency against expected canine tolerability.

Drug-to-antibody ratio

Controlled DAR and site-specific conjugation for consistent, reproducible product.

Biomarker selection

A validated canine biomarker assay to enroll and treat the dogs most likely to respond.

Our approach

We pair a modality with 15+ FDA-approved human precedents with a computational, AI-generated antibody discovery process — replacing months of traditional discovery campaigns with rapid in-silico candidate generation, lowering both the cost and the time to a clinic-ready canine antibody.

Our model

Built for capital efficiency

Onquell is structured to be capital-efficient at every stage of development — discovery, CMC and clinical execution — while holding each phase to U.S. regulatory standards. IP and regulatory strategy are held in the United States.

A phase-gated path to FDA approval

Each phase must earn the next through defined technical, regulatory and clinical proof points.

  1. Phase 1Discovery and proof of conceptAI-generated canine antibody candidates, prototype ADC, binding, internalization and selective killing
  2. Phase 2INAD-enabling and CMCCandidate nomination, canine PK, pilot safety and a GMP clinical lot
  3. Phase 3Field dose-findingSafety, PK and early response in client-owned dogs
  4. Phase 4Pivotal study and submissionPivotal field study and application to FDA-CVM

Regulatory strategy. ONQ-001 is expected to be regulated as a new animal drug by FDA-CVM. Our lead indication is chosen to qualify for MUMS conditional approval, followed by full approval, the same route recent canine cancer drugs have taken.

Let's build the future of veterinary oncology

We welcome conversations with investors, veterinary oncologists, clinical sites and development partners.

info@onquell.com