Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics Plc

Oxford Biodynamics granted US Foundation of NIH PACT Award for prognosis of cancer patients with IO-triggered Hyper-Progressive Disease

· Recipient of a PACT Award worth $963,000 to help reduce to practice a blood-test for prognosis of patients with IO-triggered Hyper-Progressive Disease (HPD)

· HPD is an acute and highly adverse/potentially fatal reaction to Immunotherapy with checkpoint inhibitors

· This is the second Foundation of NIH PACT award for OBD in two years

· OBD's EpiSwitch 3D genomics platform is well‐recognized and supported amongst the PACT consortium's pharmaceutical stakeholders

Oxford, UK - 02 May, 2023 - Oxford BioDynamics, Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, announces that it has been granted the FNIH Partnership for Accelerating Cancer Therapies (PACT) Award to reduce to practice the EpiSwitch test for prognosis of acute adverse response to immune checkpoint inhibitor (ICI) therapy associated with IO-triggered Hyper-Progressive disease (HPD).

The award worth $963,000 follows the Company's successful execution of a $910,000 grant awarded in August 2021 [1]. The prestigious award is executed by the Foundation for the National Institutes of Health (FNIH), a US not‐for‐profit organization managing the pre-competitive collaboration between the National Institutes of Health (NIH), National Cancer Institute (NCI), US Food and Drug Administration (US‐FDA), and 12 leading pharmaceutical companies comprising AbbVie, Amgen, Boehringer‐Ingelheim, Bristol‐Myers Squibb, Celgene, Genentech/Roche, Gilead, GlaxoSmithKline, Janssen, Novartis (NIBR), Sanofi, and Pfizer, as part of the Beau Biden Cancer Moonshot™ Initiative accelerating cancer research [2]. PACT's primary goal is to provide a systematic approach to cancer biomarker investigation in clinical trials by supporting the development of standardized biomarkers and assays.

Immuno‐oncology (IO) has offered a breakthrough in cancer management, with some of the most efficacious examples of treatment. Immune checkpoint inhibitors (ICIs) block checkpoint proteins, such as the PD-1 receptor and its ligand PD-L1, from binding with one another. This helps to reset a patient's immune system, which in turn enables the host's system to effectively fight cancer cells.

However, a subgroup of patients with a specific immune profile, termed Hyper-Progressive Disease, react to ICIs treatment with accelerated tumor growth rates and significantly reduced overall survival. In an analysis of 24 studies and 3,109 patients, the incidence of HPD averaged close to 12% [3]. To fully benefit from the advantages of ICI cancer therapies, and to efficiently manage cancer patients and clinical trials alike, an early prognosis of HPD has been one of the long outstanding clinical needs. Since the onset of the first ICI trials, there has been an acute shortage of biomarker tools to help identify potential hyper-progressors. Now, based on the results of the prototype Hyper-ICI Response Test (HiRT), this PACT Award will support the reduction to practice of the test, which will identify a common profile of the Hyper Progressive Disease in blood, well before starting ICI therapy.

OBD's EpiSwitch 3D genomics platform is well‐known amongst the consortium's pharmaceutical companies and has been used for practical patient stratification in prognostic, predictive and early diagnostic applications across immuno‐oncology, autoimmune and neurodegenerative indications [6].

Dr Stacey Adam, Associate Vice President, Science Partnerships at the FNIH, said: "Oxford BioDynamics has demonstrated its expertise in end-to-end biomarker development with its first PACT award. Today, the PACT partners are pleased to show their support once again, this time to enable a non‐invasive and more accurate risk assessment of patients having a hyper-progressive disease prognostic profile when being considered for immunotherapy."

Thomas Guiel, COO of Oxford BioDynamics, said: "The recognition of the EpiSwitch® platform for a second time by the consortium of US federal agencies and top pharmaceutical stakeholders is another validation of OBD's ability to address the clinical challenges of personalized medicine, cancer treatment, and immune health using our 3D genomics technology and knowledgebase.

"Hyper-progressive response to immunotherapy has been, for too long, a festering challenge on the side of the otherwise highly successful IO field. Without any prognostic tools, it has become "a bridge too far" for the biomarker industry. We are determined to cross that bridge now for the benefit of the whole industry and patient community."

-Ends-

References

[1] Oxford BioDynamics Plc. (2021). Oxford BioDynamics awarded US FNIH Grant to apply EpiSwitch® Immune Health test for improved prediction of patient response to Immune Checkpoint Inhibitor (ICI) cancer therapies. https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1503717

[2] Foundation for the National Institutes of Health (last accessed March 2023). Partnership for Accelerating Cancer Therapies (PACT). https://fnih.org/our-programs/partnership-accelerating-cancer-therapies-pact

[3] Park, H. J., et al. (2021). Definition, Incidence, and Challenges for Assessment of Hyperprogressive Disease during

Cancer Treatment with Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis, JAMA Network Open, Vol. 4, No. 3. https://doi.org/10.1001/jamanetworkopen.2021.1136

[4] Oxford BioDynamics Plc. (2022). EpiSwitch CiRT. https://www.mycirt.com

[5] Hunter, E., et al. (2021). 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. MedRxiv, 2021.12.21.21268094. https://doi.org/10.1101/2021.12.21.21268094

[6] Oxford BioDynamics plc. (last accessed March 2023). Publications. https://www.oxfordbiodynamics.com/media-center/publications

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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 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 10,000 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.

About PACT

The Partnership for Accelerating Cancer Therapies, or PACT, is a five‐year project meant to support research that seeks to identify, develop and validate robust biomarkers ‐ standardized biological markers of disease and treatment response ‐ to advance new immunotherapy treatments that harness the immune system to attack cancer, it is overseen by the Foundation for the National Institutes of Health. The pharma companies participating that have made this grant award possible are: AbbVie, Amgen, Boehringer Ingelheim, Bristol‐Myers Squibb, Celgene Corporation, Genentech, Gilead, GlaxoSmithKline, Janssen/Johnson & Johnson, Novartis, and Pfizer.

About the Foundation for the National Institutes of Health

The Foundation for the National Institutes of Health creates and manages alliances with public and private institutions in support of the mission of the NIH, the world's premier medical research agency. The Foundation, also known as the FNIH, works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. The FNIH organizes and administers research projects; supports education and training of new researchers; organizes educational events and symposia; and administers a series of funds supporting a wide range of health issues. Established by Congress, the FNIH is a not‐for‐profit 501(c)(3) charitable organization. For additional information about the FNIH, please visit fnih.org.