The global pet industry is set to expand rapidly over the next decade due to a growing pet population worldwide, driven by the continued humanization of animal companions, as reported by Bloomberg Intelligence. The US continues to remain the largest pet market and is growing, driven largely by an increase in spending on pet healthcare. The NIH National Cancer Institute estimates that roughly 6 million new cancer diagnoses are made in dogs each year. In their lifetimes, 1 in 3 dogs are diagnosed with cancer, the number one killer of our furry friends. However, currently there are only three drugs approved and one conditionally approved by the FDA to treat cancer in dogs. Chemotherapy for dogs can be toxic, expensive, antiquated and difficult to access. Cancer care is the largest unmet need for dogs.
Human oncology R&D has traditionally relied on murine models. But using mice for human cancer therapy research has its drawbacks and lacks real world evidence. Mice cancers are induced in labs, instead of naturally occurring. There are also major biological differences between mice and humans. As the NIH points out, the large population of pets with cancer provides the opportunity to study spontaneous cancers similar to those seen in humans. Canines as a model for human cancer have valuable advantages. Dogs share biological and environmental similarities with humans, and have a higher rate of spontaneous cancer.
That’s why One Health, the genomics precision oncology company was founded. By leveraging AI, the Company’s data-first approach accelerates oncology R&D, improving patient outcomes on both sides of the leash with dual-platform:
1. Fidocure Platform - the 1st-in-class precision medicine platform, delivering care for dog cancers;
2. Fetch Platform - building upon the data collected from FidoCure, provides proprietary canine learning datasets that de-risks treatments and generates predictive cancer tools for dogs.
* Canine Genomics Precision Oncology Platform: Cancer is the #1 killer of dogs, and represents the largest unmet need in canine healthcare. One Health is bringing 1st-to-market individualized precision medicine to canine cancer patients, improving care while generating the world’s largest real-world evidence (“RWE”) database for canine cancer genomics. One Health’s care platform has proven to improve life expectancy for dogs with cancer by up to 3x versus traditional care strategies.
* Translational Medicine for Human Cancer Research: The large population of canines with cancer provides a valuable opportunity to study spontaneous cancers similar to those seen in humans. Unlike current clinical animal models, dogs share biological and environmental similarities with humans, creating a novel translational medicine opportunity. By studying the RWE data One Health collects, pharma companies are able to expedite the research and development of new human and canine oncology drugs.
* Large and Growing Market Opportunities: The global pet industry is set to expand rapidly to almost $500 billion by 2030. The US represents the largest pet market and is growing, driven by an increase in spending on pet healthcare. In addition, the human oncology market continues to grow with global sales forecasted to reach $250B by 2024, and translational medicine has the opportunity to capture up to 10% of this market.
* Validated Canine Translational Models for Humans: One Health has published datasets validated in two Nature papers (available here and here), in partnership with Stanford AI Health, which highlight how naturally occurring canine cancers share remarkable similarities to their human counterparts. Validating canines as a translational model of human cancer opens up a wide spectrum of targeted therapies for further investigation.
* Data Flywheel Business Model: Through delivering precision medicine diagnoses and therapeutics to canine cancer patients, One Health is paid to collect data that is then added to its proprietary database, which in turn is able to be monetized through lucrative partnerships with pharma companies in order to fuel new and existing drug research and development for both canines and humans. One Health’s business model allows the Company to monetize each step of the process.
* Technical & Experienced Team: One Health boasts a team of expert oncologists, veterinarians, data scientists and medical researchers with decades of experience across the human and pet healthcare industries and world-class academic research. Existing partnerships with the Broad Institute and the Stanford AI Lab provides extensive support to One Health’s scientific and technical teams.
* Strategic Investors with Domain Expertise: Existing investors in One Health include Polaris Partners, Andreessen Horowitz, Lerer Hippeau, Tau Ventures, Y Combinator and Amy Abernethy. This diverse set of investors can provide long-term support for the Company’s growth through capital investment and strategic support.
* Pre-Series B SAFE Opportunity: One Health is raising up to $7M in a Pre-Series B SAFE, with terms set by Polaris Partners and participation from new and prior investors. The planned use of proceeds include expansion of the business development team and further investment in the data science platform capabilities.
The veterinary oncology market, providing care for pets and other animals with cancer, is a large and growing market driven by increased pet ownership around the world, especially in the US. According to Forbes, compiling information from the American Veterinary Medical Association among other sources, 66% of American households own a pet (86.9M homes), with 65.1M owning a dog. In 2022, total spend on American pets eclipsed $136B, a 50% increase from 2018 totals. Of the 2022 total spend, $36B was spent on veterinary costs. According to the NIH, there are 6M new cancer diagnoses made in dogs each year. This increase in spending combined with the growing number of household dogs represents a large and growing market opportunity for One Health’s FidoCure business to deliver precision medicine to more canine patients, while continuing to gather valuable real world data for pet and human biopharma partners.
The below chart showcases the current standard costs for treating canine cancer patients. Current solutions include chemotherapy, radiation, and surgery, all costly options that rely on dated research, methods and technologies. With FidoCure, precision medicine diagnosis and treatment becomes available at similar costs, and has shown to improve lifespans by up to 3x traditional treatments.
The human translational medicine market is a growing subsection of drug research and development that looks to real-world evidence (“RWE”) of how existing drugs interact with diseases to guide the next generation of therapeutic development. The promise of personalized medicine, providing the most effective treatment based on a patient’s individual characteristics and traits, can be made possible by utilizing RWE in conjunction with newly developed data analysis tools that can compare genomic and phenotypic data across species and patients.
Partnerships for translational medicine data for drug development are typically constructed with a royalty structure ranging from 1-10% of total drug sales. For example, a 1% royalty of a new indication that achieves $1-2B in total sales would account for $100-200M in revenue to a data provider like One Health.
Through the power of the Fetch data platform and FidoCure care delivery services, One Health has the ability to partner with a broad spectrum of pharmaceutical companies, unlocking multiple opportunities for large value creation with very attractive margins. Examples include:
- Clinical Drug Development: combination therapies (early indications for drugs that will work in humans), label extensions (for use in other indications), discarded asset resurfacing
- Preclinical Drug Development: de-risking later stage drug development with canine clinical trial data
- Data/Discovery: licensing out dataset for mining for new target IDs and validation
The overall human oncology market is massive and continues to grow. There were $143B in branded oncology therapeutic sales in 2019, with global sales forecasted to reach $250B by 2024. The subsection of this market for small molecule oncology drugs, which are critical to targeted cancer therapy, reached $76B in 2020, with a forecasted CAGR of ~10% through 2027 to reach a $147B market.
FidoCure is the 1st Precision Medicine platform for canine cancer. The platform tests, reports findings, and treats dog cancers with FDA-approved human cancer drugs. Pet parents enroll the patients through vet clinics and get onboarded to the FidoCure platform. FidoCure’s delivery of care and data collection process has four steps:
- Test: dog tumor DNA and phenotypic data collected at the vet clinics and sent for test at a partner laboratory
- Report: based on the test result, using AI to identify variants potentially associated with therapeutic benefit
- Treat: 12 targeted therapies launched and currently available, drug provided via pharmacy partners
- Data: clinical and genomic data collected and analyzed
Data is gathered at each step across vet clinics nationwide. FidoCure has partnered with IDEXX, a top pet healthcare company, Thrive Pet Healthcare, one of the first vet service hospital groups, and many new clinics to conduct this service. With the FidoCure approach of pairing targeted therapies with specific gene mutations, the platform has observed up to a 3X improvement in median survival days in dogs with cancer. The results have been validated alongside researchers at Stanford AI Health and are showcased in papers published by Nature. The analysis in the paper identifies prognostic concordance between canines and humans in several key oncogenes, as well as several targeted treatments designed for humans are associated with a positive prognosis when used to treat canine tumors. The paper highlights the value of canine models in advancing drug discovery for human oncology.
FidoCure is developing the ctDNA – Liquid biopsy service, collaborating with the Broad Institute of Harvard and MIT. Liquid biopsy collects canine blood samples for testing, is non-invasive, rapid and precise. This new service will be launched in late 2023 for the veterinary community. So far, FidoCure has sequenced, treated, and collected data from over 4,400 dogs. The platform has delivered 15,000 targeted therapy orders, collected 1.2 billion data points, achieved 85% repeat rate from oncologists, 75% vet oncologist adoption, 75% engagement rate. It is working with two largest animal health players Thrive and IDEXX, and over 1,000 vet clinics in the world.
The second part of One Health’s value proposition is the FidoCure Fetch data platform. Fetch is the world’s largest commercial canine-omics database, and includes data on both canine patient treatment and outcomes. The second Nature paper published by the One Health team validates the potential for real world canine cancer models to be predictive of human clinical data. The study identified significant overlap between mutations in canine and human tumors across specific oncogenes and tumor types. The findings better positioned canines as a translational model of human cancer to investigate a wide spectrum of targeted therapies. With this validation, One Health provides a strong foundation for the utilization of its Fetch platform for both veterinarians delivering care and researchers working on new drugs and indications. The platform is split into two offerings:
Fetch for Veterinarians: One Health provides veterinary clients with a portal for identifying actionable care options for any dog by utilizing the platform’s genomics, phenotypic, Rx, adverse event and outcomes data. This unlocks true precision medicine for canine cancer patients, improving outcomes and enabling veterinarians to deliver the best care possible. When paired with One Health’s DNA sequencing diagnostics offering, veterinarians gain a wealth of information on their patients, including detection of mutations or abnormalities that can impact tumor growth, spread, and response to various therapies. In addition, the Fetch platform will make recommendations on ideal therapeutics from One Health’s growing toolbox of FDA-approved human cancer drugs, with dosages tailored specifically to the dog. The One Health data flywheel model allows for the Fetch platform to grow more powerful with each patient treated, leading to continuously improved treatment recommendations and outcomes.
Fetch for BioPharma: For BioPharma partners, One Health provides the world's largest database of real-world evidence data from all dogs treated through the FidoCure platform. Partners gain access to raw data files in partnership with One Health to develop and bring new therapeutics to market. This data can be used for a variety of research purposes, including:
* Oncology drug co-development
* Existing drug label expansion
* Adverse events prediction
* Research into new focus areas
* Pan-disease risk factors and outcomes data
The Fetch platform offers a valuable and growing value proposition to researchers working on both human and canine therapeutics. By mining the data, non-obvious uses of known drugs in humans can be uncovered, providing new care possibilities for humans and dogs while expanding market opportunities for drug makers. In addition, the Fetch platform generates in vivo evidence in dogs with spontaneously arising cancer to improve human clinical trial design.
One Health has achieved real traction in partnering with large pharma companies to utilize the Fetch data platform in human drug development. Most notably, the Company has partnered with Eisai, a large pharma company listed on the Tokyo Stock Exchange with a ~$19B market cap. Eisai came to One Health as the former was preparing to launch a new clinical trial to extend the label of an established drug in its pipeline, but mice model data was not compelling enough to take to human trials. One Health was able to generate spontaneous disease data in dogs by providing treatment and monitoring outcomes. This data not only enabled Eisai to move forward with human trials, but accelerated the trail to Phase II. One Health was paid $30k per dog in the data set used, with further capacity for milestone payments as the Eisai trials continue.
One Health has two primary IP strategies, one for the pet healthcare market and one for the human healthcare market. Through Company’s novel, ‘off-label’ use of FDA-approved human cancer therapeutics in canine cancer patients, any new association of these drugs with a canine tumor is novel science, and are captured under an international omnibus patent application that will cover the use of these drugs in dogs.
In addition, through the Fetch AI platform, notable off-label signals that the Company picks up on existing drugs can enable One Health to apply for IP on extending the drug labels for human applications based on the canine data sets. This unlocks a massive opportunity for BioPharma companies to expand the use cases for existing drugs, and presents a very attractive partnership opportunity for One Health via a royalty payment structure.
Christina Lopes, Founder & CEO: Prior to founding One Health with her husband Ben Lewis, Christina Lopes was managing director of Cerberus Capital, with $30B AUM. She has also served as an advisory board director for International Planned Parenthood (Western Hemisphere), which provides 30 million health services per year. Christina participated in The United Nations Commission for the Status of Women, and lectured at Columbia University. Christina was also honored as a Rising Talent by the Women’s Forum in 2014, and as a Young Global Leader by the World Economic Forum at Davos for her pioneering efforts in both deal making and women’s health. Christina received her B.A. from the University of Massachusetts, a Masters in International and Political Affairs from Columbia University, and Doctoral Coursework in Ethics at Princeton University.
James Zou, PhD, Chief AI Scientist: James Zou leads One Health’s data science platform development efforts as a leader in applying AI technologies to human disease and health. In addition to working with One Health, James leads a team at the Stanford AI Lab dedicated to making machine learning more reliable, human-compatible and statistically rigorous, and has published more than 100 papers on AI and machine learning. James has been recognized and awarded as a Sloan Research Fellow, an NSF CAREER Award recipient, a Chan-Zuckerberg Investigator, a Simons Research Fellow, a Google Faculty Award recipient, and as a Gates-Cambridge Scholar. James received his PhD in applied mathematics and computational biology from Harvard.
Dr. Gerald Post, DVM, Chief Medical Officer: Dr. Gerald Post is the Founder and Chief Medical Officer of The Veterinary Cancer Center, a specialized veterinary practice dedicated to the diagnosis and treatment of cancer in animals. He is one of only a few hundred board-certified veterinary oncologists in the United States and has more than 25 years of practice experience. He is the author or co-author of numerous articles, research papers, and book chapters in both oncology and hematology, including two seminal publications advancing treatment of both B-cell lymphoma and T-cell lymphoma in dogs. Dr. Post received his DVM from University of Minnesota, and his BS from Cornell.
Dr. Michelle White, DVM, PhD, Head of Science: Dr. Michelle White joined One Health in 2022 as the Head of Science. She is particularly driven by excitement and urgency to use precision medicine to help dogs and humans. Prior to One Health, Dr. White served as Senior Research Scientist at the Broad Institute of MIT and Harvard, where she collaborated with two One Health scientific advisory board members, Dr. Cheryl London and Dr. Corrie Painter. Dr. White received her DVM and PhD in Translational Medicine from Cornell.
Chase Schwalbach, Chief Product Officer: Chase joined FidoCure as Chief Product Officer in 2022. He brings with him extensive experience in Genomics, Engineering, and Data Science. Prior to joining FidoCure, Chase spent over 5 years at Tempus Labs, joining as employee 90 and playing instrumental roles in Engineering, Data Science, Operations, and Science R&D while the company scaled to >2,000 employees as the Head of R&D Product and Strategy among other roles. He also spent time in the leadership suite of Avant, a FinTech firm, and as a Quant Trader at DRW Trading Group. Chase earned a BA in Finance from Morehead State University.
Cancer is the second most common cause of death in the US, with 1.9M new cases diagnosed each year and more than 600k deaths. In dogs, it is the leading cause of death in the US, responsible for 47% of pet deaths. In spite of the immense investment of time, resources and capital from public and private sectors for decades, curing cancer remains a significant unmet need in the healthcare industry. One Health is working to improve care through its precision medicine platform for canine cancer patients, while simultaneously providing pharma companies with a large dataset capable of improving both human and canine drug development processes, with the promise of enabling new drug and drug applications to reach the patients who need them and save lives.
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