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

Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing targeted clinical diagnostic tests for immune health utilizing its EpiSwitch^® 3D genomics technology, announces that it has been awarded an FNIH Partnership for Accelerating Cancer Therapies (PACT) Grant to use the EpiSwitch diagnostic platform for accurate prediction of a patient's response to Immune Checkpoint Inhibitors (ICIs) from a routine blood sample.

The grant worth $910,000 (RFA #2021-PACT001) is executed by the Foundation for the National Institutes of Health (FNIH), a US not-for-profit organization managing the precompetitive 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 Moonshottm Initiative accelerating cancer research. PACT seeks to provide a systematic approach to cancer biomarker investigation in clinical trials by supporting development of standardized assays.

Immuno-oncology (IO) focuses on using an individual's immune system to help fight their cancer using a class of drugs, ICIs, to target either of the immune regulatory proteins PD-1 or PD-L1. At present, of those deemed eligible to receive an ICI, less than 30% will benefit from these drugs^[1]. Unfortunately, a similar number will experience significant and sometime fatal side effects when these therapies are used^[2].

Current testing modalities cannot predict who will and won't respond and generally require an invasive tumor biopsy. Development of a predictive test, one that only requires a small blood sample, will help oncologists to successfully deploy these drugs as well as enable the pharmaceutical companies to further understand and develop IO therapies to expand their benefits.

In Q4 2021, OBD expects to launch the "EpiSwitch^® ICI Response Test" as an LDT to allow access for oncologists who want to use it immediately and to start shaping the market.

The test, which is a predictive diagnostic of likely response in cancer patients considered for monotherapy treatment with immune checkpoint inhibitors, has been in full development since 2018. More than 800 blood samples from multiple cohorts of patients have been analyzed, including several studies where the outcomes were blinded to validate the predictive abilities of this technology. The aim of the test is to help oncologists deploy ICI drugs more successfully as well as enable pharmaceutical companies to further understand and develop IO therapies to expand their benefits.

The two-year $910,000 PACT Grant awarded to OBD will fund extended application of this technology to the analysis of primary and acquired resistance to ICI in several trials, including over 186 longitudinal samples from an observational trial, encompassing at least 4 separate ICI therapies and 7 common cancer types. The project will further validate this first-generation immune health assay for predicting response as well as monitoring resistance to ICI monotherapies. It will also evaluate key differences in predictive profiles of the patients treated with a combination therapy of ICI and an epigenetic drug.

In awarding the PACT grant, the reviewers highlighted the strengths of OBD's success in applying the EpiSwitch^® platform for biomarker discovery, the prior experience of the team, the clinical practicality of non-invasive EpiSwitch testing from blood and the high relevance of the 3D genomic epigenetic modality.

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^[3-6].

Dr Stacey Adam, Associate Vice President, Research Partnerships at the FNIH, said:
"The PACT partners are pleased to support the development of a novel epigenetic biomarker platform that can be used in a non-invasive manner and across various clinical settings, thereby allowing for better assignment of patients to specific immunotherapies to treat their cancer."

Dr Jon Burrows, CEO of Oxford BioDynamics, said:
"The recognition of the EpiSwitch^® platform by the consortium of US federal agencies and top pharmaceutical stakeholders marks another significant validation of OBD's ability via 3D genomics technology to address the clinical challenges of personalized medicine, cancer treatment and immune health."

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References

1. Johns Hopkins, Immunotherapy: Precision Medicine in Action, accessed Jun 2021. https://www.hopkinsmedicine.org/inhealth/about-us/immunotherapy-precision-medicine-action-policy-brief.html
2. Martins F, Sofiya L, Sykiotis G P, et al. (2019). Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol 16, 563-580. https://doi.org/10.1038/s41571-019-0218-0
3. Carini C, Hunter E, et al. Chromosome conformation signatures define predictive markers of inadequate response to methotrexate in early rheumatoid arthritis. J Transl Med. 2018.
4. Hunter E, McCord R, et al. Comparative molecular cell-of-origin classification of diffuse large B-cell lymphoma based on liquid and tissue biopsies. Transl Med Commun. 2020;5.
5. Shah P, Hunter E, et al. Development and validation of baseline predictive biomarkers for response to immuno-checkpoint treatments in the context of multi-line and multi-therapy cohorts using EpiSwitch epigenetic profiling. J Immunother Cancer. 2019;7.
6. Hunter E, Koutsothanasi C, et al. (2021). 3D genomic capture of regulatory immuno-genetic profiles in COVID-19 patients for prognosis of severe COVID disease outcome. BioRxiv, 2021.03.14.435295. https://doi.org/10.1101/2021.03.14.435295