Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics ("OBD" or the "Company" and, together with its subsidiaries, the "Group")

OBD

Oxford BioDynamics develops a high accuracy,discriminating diagnostic test for multiple canine cancers

· EpiSwitch® Specific Canine Blood (EpiSwitch® SCB) test is a new canine multi-cancer diagnostic test based on OBD's non-invasive EpiSwitch® array platform

· Test developed in collaboration with leading US KOL Professor Jaime F Modiano, University of Minnesota, USA

· Test offers early blood-based detection and discrimination of six high-utility, frequently occuring cancer types: three sarcomas, two lymphomas, and malignant melanoma, each with balanced accuracy of >89%

· Real-world utility data with selected veterinary services will further validate the test

Oxford, UK - 4 June 2024 - Oxford BioDynamics Plc (AIM: OBD, the "Company"), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, announces development of a high-accuracy, discriminating multi-cancer canine diagnostic test for veterinary medicine.

The test was developed in collaboration with Veterinary Referral Associates, Gaithersburg MD, USA; Animal Cancer Care and Research Program, University of Minnesota, St. Paul, MN, USA; Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, St. Paul, MN, USA; Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA; Center for Immunology, University of Minnesota, Minneapolis, MN; Stem Cell Institute, University of Minnesota, Minneapolis, MN; Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, MN; and Institute for Engineering in Medicine, University of Minnesota, Minneapolis, MN.

OBD's EpiSwitch® SCB ("Scooby") test is a well balanced, highly accurate blood test to specifically diagnose canine diffuse large B-cell lymphoma (DLBCL), T-zone lymphoma (TZL), hemangiosarcoma (HSA), histiocytic sarcoma, osteosarcoma, and canine malignant melanoma, in a powerful single assay format. The test was validated using 3D whole-genome profiling in peripheral blood. It demonstrated high sensitivity and specificity for lymphomas and sarcomas as a class (accuracy >80%); and high sensitivity and specificity for specific individual indications, with an accuracy >89%. The validation results are published in BioRxiv (link here).

There is a critical need in veterinary oncology for an accurate, specific, sensitive, non-invasive (blood) biomarker assay to assess canine oncological indications earlier, to better inform therapeutic interventions. Current alternatives for non-invasive canine cancer detection deliver only a "cancer/no cancer" outcome, with low specificity and no distinction between different cancer types. Effective therapeutic intervention requires a definitive identification of a specific cancer type - often a difficult task in current veterinary practice.

OBD's newly published study demonstrates a novel 3D genomic approach that can diagnose six canine cancers, as well as support continuing upgrade for additional diagnostic profiles, in a modular manner. The EpiSwitch® SCB test promises to help veterinary specialists to diagnose the disease, make more informed treatment decisions, minimize or avoid unnecessarily toxicity, and efficiently manage costs and resources.

EpiSwitch SCB will be made available to a select group of vets who will generate real-world utility data that will further validate the test. It is expected that the commercialisation of the EpiSwitch ECB test will be through a partnership or outlicensing arrangement with an organisation with an existing presence in the pet healthcare market.

Dr Sara Fritz, Veterinary Referral Associates, Gaithersburg MD, USA, said: "My first use of the EpiSwitch SCB test helped navigate a very complex case of canine cancer relapse in the absence of options from the current standards of care. This test opens possibilities for a quick and reliable diagnosis in the very cases where time is at premium."

Professor Jaime Modiano, College of Veterinary Medicine and Masonic Canecr Cemnter, University fo Minnesota, USA said: "The ability to detect the presence of common, life-threatening dog cancers with high accuracy using blood samples provides an improvement over current methods of diagnosis, reducing or eliminating the need for invasive biopsy procedures. I believe that the eventual implementation of these tests also has potential to enhance the precision and therefore improve the management and outcomes of canine cancer patients."

Dr Alexandre Akoulitchev, CSO, OBD said: "EpiSwitch SCB combines all the advantages of EpiSwitch blood based biomarkers with a novel proprietary multi-choice EpiSwitch array design. Once again, we were determined to translate to practice the full potential of our EpiSwitch technology, this time to tackle a prevalent veterinary challenge in support of our four legged friends."

Reference

Ewan Hunter, Matthew Salter, Ryan Powell, Ann Dring, Tarun Naithani, Dominik Vugrinec, Kyrylo Shliaiev, Mutaz Issa, Cicely Weston, Abigail Hatton, Abel Gebregzabhar, Jane Green, Anthony Blum, Thomas Guiel, Sara Fritz, Davis Seelig, Jaime F Modiano, Alexandre Akoulitchev

bioRxiv 2024.05.22.595358; doi: https://doi.org/10.1101/2024.05.22.595358

Whole Genome 3D Blood Biopsy Profiling of Canine Cancers: Development and Validation of EpiSwitch Multi-Choice Array-Based Diagnostic Test.

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Notes for Editors

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) is a global biotechnology company, advancing personalized healthcare by developing and commercializing precision medicine tests for life-changing diseases.

It has two commercially available products: the EpiSwitch® PSE (EpiSwitch Prostate Screening test) and EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) blood tests. PSE is a blood test that boosts the predictive accuracy of a PSA test from 55% to 94% when testing the presence or absence of prostate cancer, launched in the US and UK in September 2023. CiRT is a predictive immune response profile for immuno-oncology (IO) checkpoint inhibitor treatments, launched in February 2022.

The Company's product portfolio is based on a proprietary 3D genomic biomarker platform, EpiSwitch®, which can build molecular diagnostic classifiers for the prediction of response to therapy, patient prognosis, disease diagnosis and subtyping, and residual disease monitoring, in a wide range of indications, including oncology, neurology, inflammation, hepatology and animal health.

In March 2021, the Company launched the first commercially available microarray kit for high-resolution 3D genome profiling and biomarker discovery, EpiSwitch® Explorer Array Kit, which is available for purchase by the life science research community. 

Oxford BioDynamics has participated in more than 40 partnerships with big pharma and leading institutions including Pfizer, EMD Serono, Genentech, Roche, Biogen, Mayo Clinic, Massachusetts General Hospital and Mitsubishi Tanabe Pharma.

The Company has created a valuable technology portfolio, including biomarker arrays, molecular diagnostic tests, bioinformatic tools for 3D genomics and an expertly curated 3D genome knowledgebase comprising hundreds of millions of data points from over 15,000 samples in more than 30 human diseases.

OBD's group headquarters and research, product development and UK clinical laboratories are in Oxford, UK. It also has a commercial office in Gaithersburg and a clinical laboratory in Frederick, MD, USA, and a reference laboratory in Penang, Malaysia.

The company is listed on the London Stock Exchange's AIM, with ticker OBD. For more information, please visit the Company's website, www.oxfordbiodynamics.com, or follow OBD on Twitter (@OxBioDynamics) and LinkedIn.

About EpiSwitch®

The 3D configuration of the genome plays a crucial role in gene regulation. By mapping this architecture and identifying abnormal configurations, EpiSwitch® can be used to diagnose patients or determine how individuals might respond to a disease or treatment.

Built on over 10 years of research, EpiSwitch® is Oxford Biodynamics' award-winning, proprietary platform that enables screening, evaluation, validation and monitoring of 3D genomic biomarkers. The technology is fully developed, based on testing of over 15,000 samples in 30 disease areas, and reduced to practice.

In addition to stratifying patients with respect to anticipated clinical outcomes, EpiSwitch® data offer insights into systems biology and the physiological manifestation of disease that are beyond the scope of other molecular modalities. The technology has performed well in academic medical research settings and has been validated through its integration in biomarker discovery and clinical development with big pharma.