Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics presents clear clinical utility data of the Checkpoint Inhibitor Response Test (EpiSwitch® CiRT) at ASCO 2022, June 3-7

· EpiSwitch CiRT is a first-of-its-kind precision medicine test that predicts a patient's most likely response to Immune Checkpoint Inhibitor (ICI) therapy

· The Company will be presenting data on a key patient cohort used to develop the EpiSwitch CiRT diagnostic that shows clinical utility across ICI therapies and oncology indications

· The American Society of Clinical Oncology (ASCO) annual meeting is attended by thousands of oncologists, oncology care team members and pharma drug developers every year

· EpiSwitch CiRT has seen encouraging uptake by early adopters since it was launched in the US on February 25th, 2022

Oxford, UK - 5 May 2022 - Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for immune health based on the EpiSwitch® 3D genomics platform, announces that it will be presenting significant data related to the development of its flagship CiRT clinical assay at the upcoming ASCO 2022 Annual Meeting in Chicago.

While attending OBD will present the abstract titled "Development and validation of blood-based predictive biomarkers for response to PD-(L)-1 checkpoint inhibitors: evidence of a universal systemic core of 3D immunogenetic profiling across multiple oncological indications" [1], describing the development of the CiRT clinical assay. ASCO connects a global network of nearly 45,000 oncology professionals and is the leading resource for best practices in clinical oncology research and academic and community practice.

Oxford Biodynamics will be represented in person at the meeting by members of its clinical operations, product development, sales and marketing and corporate development teams.

"We greatly value this opportunity to meet face to face with clinical oncologists and other stakeholders at ASCO," said Thomas Guiel, OBD's Chief Operating Officer. "We have many meetings with practicing oncologists, pharma clinical development teams and investors scheduled. These meetings are essential to gain further exposure and educate the oncology community about the utility of CiRT." Please visit http://asco.mycirt.com to arrange a face-to-face meeting at ASCO between June 3-7, 2022.

An estimated 16.6M people were living with cancer in the US in 2019. And it is estimated that there will be 1.9M new cancer cases in 2022 [2]. Across the 15 indications for which immune checkpoint inhibitors have been approved as the first line (1L) or the second line (2L) of treatment, approximately 40% of all patients are eligible for ICI therapy [3]. Oncologists have actively adopted the use of these therapies, and within the class of immune checkpoint inhibitors (ICIs), anti-PD1/PDL1 antibodies have become some of the most widely prescribed and tested anticancer therapies [4].

The Checkpoint inhibitor Response Test (CiRT) was launched at the end of February 2022 as a Laboratory Developed Test (LDT). By launching the test as an LDT, OBD has provided immediate access to early adopters and enabled clinical utilization for the test, a strategy other diagnostic companies have adopted in the blood-based cancer screening space, including Grail and Guardant [5]. In addition, OBD is working closely with payors to move beyond the miscellaneous CPT code‡ for testing towards establishing a unique descriptor and code that defines the EpiSwitch 3D genomics platform and the CiRT diagnostic as: "Oncology (pan-tumor), genetic profiling of eight DNA regulatory (epigenetic) markers by quantitative PCR, whole blood, reported as a high or low probability of responding to immune checkpoint inhibitor therapy".

Delivering the CiRT diagnostic as an LDT is key to delivering this important oncology test into the hands of physicians to enable utilization and help drive the transformation of how checkpoint-inhibitor immunotherapy is recommended and administered to patients as efficiently as possible. Read more about CiRT's launch coverage by Precision Oncology News here [6].

Dr Jon Burrows, CEO of OBD, said: "Since the February 25th launch, we have seen positive early traction for our test, with five initial orders for the test in March and 17 test orders in April by four different oncology groups. This is very encouraging engagement from early adopters with respect to an innovative and new genomic platform technology. This growing early adoption is promising, and oncologist feedback is positive."

Dr Steve Mamus, a nationally recognized oncologist serving as Medical Director of Oncology / Hematology and founder of the Cancer Center of Sarasota (FL, USA) commented "EpiSwitch CiRT has demonstrated that it can stratify patients in either a high or low response likelihood category with high accuracy. This promises to add real value - both supporting our decision on whether ICI [immune checkpoint inhibitor] therapy is appropriate for a patient and giving us a rational approach to stopping and/or restarting therapy at the right time. We need tools such as EpiSwitch CiRT to provide evidence supporting whether persevering after an irAE (adverse events related to toxicities) is the right call for an individual patient." Read more from Dr Mamus here [7].

Please visit http://asco.mycirt.com to arrange a face-to-face meeting at ASCO between June 3-7, 2022.

For more about CiRT, please visit www.myCiRT.com

Footnote: ‡ A Current Procedural Terminology (CPT) code is used in the US to report medical and diagnostic services to entities such as health care professionals and payers.

References:

1. Hunter, E., et al. (2022), Development and validation of blood-based predictive biomarkers for response to PD-(L)-1 checkpoint inhibitors: evidence of a universal systemic core of 3D immunogenetic profiling across multiple oncological indications. ASCO Annual Meeting 2022, [attendee link]

2. Reports on Cancer: Cancer Stat Facts. National Cancer Institute SEER Program. National Cancer Institute; 2022. [online] Accessed May 4, 2022. https://seer.cancer.gov/statfacts/html/all.html

3. Haslam A., et al. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for Immune Checkpoint Inhibitor Drugs. JAMA Netw Open. 2020;3(3):e200423. doi:10.1001/jamanetworkopen.2020.0423

4. Robert, C. A decade of immune-checkpoint inhibitors in cancer therapy. Nat Commun 11, 3801 (2020). https://doi.org/10.1038/s41467-020-17670-y

5. Ashford, M., 2021. Guardant Health Laying Path for Future in Cancer Screening, Updates Launch Plans for CRC Assay. GenomeWeb. [online] Accessed May 4, 2022. https://www.genomeweb.com/molecular-diagnostics/guardant-health-laying-path-future-cancer-screening-updates-launch-plans-crc

6. Precision Oncology News, (2022) Alison Kanski: Oxford BioDynamics Gathering Real-World Data on Checkpoint Inhibitor Response Predictor, 10 Mar 2022, https://www.precisiononcologynews.com/liquid-biopsy/oxford-biodynamics-gathering-real-world-data-checkpoint-inhibitor-response-predictor

7. Biotechnology News Magazine, Dr Steven Mamus: Smart Test Promises to Transform How We Recommend and Administer Immunotherapy, 18 Mar 2022, https://biomag1.com/dr-steve-manus-3182

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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.

Its flagship product is EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) for cancer, a predictive immune response profile for immuno-oncology (IO) checkpoint inhibitor treatments, launched in February 2022.

In March 2021, the Company launched its first commercial prognostic test, EpiSwitch® CST (Covid Severity Test) and the first commercially available microarray kit for high-resolution 3D genome profiling and biomarker discovery, EpiSwitch® Explorer Array Kit. 

The Company has developed a proprietary 3D genomic biomarker platform, EpiSwitch®, which can build molecular diagnostic classifiers for prediction of response to therapy, patient prognosis, disease diagnosis and subtyping, and residual disease monitoring in a wide range of indications.

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 10,000 samples in more than 30 human diseases.

OBD is headquartered in Oxford, UK and is listed on AIM of the London Stock Exchange. It also has a commercial office in Gaithersburg, MD, USA and a reference laboratory in Penang, Malaysia.

For more information, please visit the Company's website, www.oxfordbiodynamics.com, or follow on Twitter or 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 10,000 samples in 30 disease areas, and reduced to practice.

In addition to stratifying patients with respect to anticipated clinical outcome, 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.