Oxford Biodyn Regulatory News (OBD)

15 July 2025

Oxford BioDynamics plc

("Oxford BioDynamics" or the "Company")

Pfizer publishes on successful use of EpiSwitch biomarkers evaluating tumour status and treatment outcomes from the JAVELIN Bladder 100 Trial

· Results strongly support the use of EpiSwitch blood-based biomarkers as an effective liquid biopsy method to evaluate and monitor the state of tissues and tumors in cancer patients

Oxford, UK - 15 July 2025 - Oxford BioDynamics Plc (AIM: OBD), a precision clinical diagnostics company bringing specific and sensitive tests to the practice of medicine based on its EpiSwitch® 3D genomics platform, is pleased to note the publication of data from Pfizer on the successful use of EpiSwitch blood-based biomarkers in the evaluation of tumour status and treatment outcomes of 496 patients from the JAVELIN Bladder 100 Trial in the journal Cancers[1]. The trial demonstrated a significant survival benefit with (immune checkpoint inhibitor) avelumab maintenance plus best supportive care (BSC) versus BSC alone. EpiSwitch blood-based biomarkers were evaluated on their association with tumour profiles and their immunophenotype, related to high and low immunogenic response.

In addition to Pfizer's Computional Biology, Translational Pathology and Precision Medicine Product teams, the study has been conducted in collaboration with St. Bartholomew's Hospital, London, UK; Princess Margaret Cancer Centre, Toronto, Canada; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA; Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York, NY, USA; Fred Hutchinson Cancer Center, Seattle, WA, USA; and Data4Cure, Inc., Waltham, MA, USA.

The data demonstrates that EpiSwitch biomarkers in blood samples strongly correlate with the immune profiles of patient tumours. The researchers conclude that EpiSwitch blood testing can effectively determine whether a tumour has high or low immune activity, which is an important factor in making informed cancer treatment decisions. The EpiSwitch technology provides accurate insights into the body's immune response to the cancer in a less invasive manner than traditional tissue biopsies. The ability to utilise this technology to identify which patients are most likely to benefit from specific treatment options represents a significant advancement in patient care. These results support the growing evidence that EpiSwitch technology, already utilised in prostate cancer testing, has the potential to revolutionise cancer detection and monitoring across various types of cancer. These advancements position Oxford BioDynamics to expand its role in the rapidly growing cancer diagnostics market, highlighting the company's potential for substantial growth and impact in precision medicine.

Dr. Alexandre Akoulitchev, Chief Scientific Officer of OBD said:

"The results from the published Pfizer study are a powerful endorsement for our blood-based biomarker EpiSwitch technology. Our systemic epigenetic readouts showed consistent insights into JAVELIN Bladder 100 patient profiles, normally obtained through biopsies and complex gene expression analysis. This is a typical example of benefits that EpiSwitch technology has been offering our pharmaceutical partners.

EpiSwitch biomarker products have already proven their quality and have been translated into clinical practice [2]. Our EpiSwitch PSE test for early prostate cancer detection is demonstrating impressive real-world clinical utility, with rapidly growing adoption across both the US and UK market [3,4]. With its remarkable 94% accuracy compared to standard PSA testing's 55%, our technology is transforming cancer detection capabilities.

The Pfizer study adds to the extensive evidence of EpiSwitch biomarkers quality, efficacy, and their full potential -all powered by our innovative EpiSwitch platform and AI-powered 3D Genomics KnowledgeBase [2]."

References: 

[1] Powles, T.; Sridhar, S.S.; Bellmunt, J.; Sternberg, C.N.; Grivas, P.; Hunter, E.; Salter, M.; Powell, R.; Dring, A.; Green, J.; et al. Blood-Epigenetic Biomarker Associations with Tumor Immunophenotype in Patients with Urothelial Carcinoma from JAVELIN Bladder 100. Cancers 2025, 17, 2332. https://doi.org/10.3390/cancers17142332

[2] Mellor, J.; Hunter, E.; Akoulitchev, A. Paradigm Lost. Cancers 2025, 17, 2187. https://doi.org/10.3390/cancers17132187

[3] Pchejetski, D.; Hunter, E.; Dezfouli, M.; Salter, M.; Powell, R.; Green, J.; Naithani, T.; Koutsothanasi, C.; Alshaker, H.; Jaipuria, J.; et al. Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection. Cancers 2023, 15, 821. https://doi.org/10.3390/cancers15030821

[4] Berghausen, J.; Abdo, J.; Mathis, R.; Hunter, E.; Akoulitchev, A.; Pohlman, G.D. EpiSwitch PSE Blood Test Reduces Unnecessary Prostate Biopsies: A Real-World Clinical Utility Study. Cancers 2025, 17, 2193. https://doi.org/10.3390/cancers17132193

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Notes for Editors

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) is an international biotechnology company, advancing personalized healthcare by developing and commercializing precision clinical diagnostic tests for life-changing diseases.

Currently OBD has two commercially available products: the EpiSwitch® PSE (EpiSwitch Prostate Screening test) and EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) blood tests. PSE boosts the predictive accuracy of a PSA test from 55% to 94% when testing the presence or absence of prostate cancer. CiRT is a highly accurate (85%) predictive response test to immuno-oncology checkpoint inhibitor treatments.

The tests are based on OBD's proprietary 3D genomic biomarker platform, EpiSwitch® which enables screening, evaluation, validation and monitoring of biomarkers to diagnose patients or determine how individuals might respond to a disease or treatment.

OBD's clinical smart tests have the potential to be used across a broader range of indications, and new tests are being developed in the areas of oncology, neurology, inflammation, hepatology and animal health.

The Group's headquarters and UK laboratories are in Oxford, UK. Its US operations and clinical laboratory are in Maryland, USA, along with a reference laboratory in Penang, Malaysia.

OBD is listed on the London Stock Exchange's AIM (LSE: OBD). For more information, please visit the Company's website, www.oxfordbiodynamics.com, X (@OxBioDynamics) or LinkedIn.