RCS - Oxford BioDynamics - OBD pursuing EpiSwitch as companion diagnostics

Oxford BiodynamicsAnnouncement

25/07/2024 07:00

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RNS Number : 7401X  Oxford BioDynamics PLC  25 July 2024

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

 

Oxford Biodynamics to present on its line of EpiSwitch® products for
companion diagnostics in cancer immunotherapy at the 14(th) World Summit for
Clinical Biomarkers and Companion Diagnostics in Boston, MA.

Oxford, UK - 25 July 2024 - Oxford BioDynamics, Plc (AIM: OBD, the
Company), a precision clinical diagnostics company bringing specific and
sensitive tests to the practice of medicine based on the EpiSwitch® 3D
genomics platform ( 1 ), announces its key-note presentation at the 14(th)
World Summit for Clinical Biomarkers and Companion Diagnostics, taking place
on 3-6 September 2024 in Boston, MA, USA.

Oxford BioDynamics will discuss the diagnostic, predictive and prognostic
power of the EpiSwitch® platform as companion assays in a keynote
presentation. The Company will cover:

·    EpiSwitch CiRT, a highly accurate (85%) Immune-Oncology (IO) response
test available today, predicts a patient's response to immune checkpoint
inhibitor therapy, giving physicians a powerful tool for patient care
management.

·    PROWES (Prospective Real-World Evidence Study); an application of
CiRT in an IRB-approved Registry Study currently enrolling up to 2,500
patients across up to a dozen oncology institutions, evaluating CiRT
performance and demonstrating the clinical utility of the test.

·    EpiSwitch® CiRT has been submitted to the New York State Department
of Health Clinical Laboratory Evaluation Program (CLEP) for approval.

·    EpiSwitch® HiRT, a prognostic test for IO-triggered Hyperprogressive
Disease, is a new test being validated by OBD to address this most detrimental
and life-threatening side effect of immunotherapy.

·    Application of a novel multiplexed Agilent® array platform to
deliver EpiSwitch® assays for early diagnosis and prevention of immune
related adverse events (irAEs) which affect up to 70% of treated patients
involving cutaneous, musculoskeletal, gastrointestinal, renal, nervous system,
endocrine, hematologic and lung toxicities.

 

Oxford BioDynamics will present a keynote address at the 14(th) Annual World
Summit for Clinical Biomarkers and Companion Diagnostics, a flagship meeting
which takes place on September 3-6, 2024 in Boston, MA. OBD will discuss its
products and pipelines of clinical assays aimed at enhancing the benefits of,
and navigating the complexities of utilizing immunotherapy, by addressing low
response rates and predicting side effects - from the life-threatening
Hyper-Progressive Disease (manifested in c. 12% of treated patients) to the
normally-anticipated immune related adverse events (affecting c. 70% of
treated patients).

The EpiSwitch® Checkpoint Inhibitor Response Test (CiRT) is a first-in-class,
blood-based, accurate predictor of response to immune checkpoint inhibitors
(ICIs) ( 2-4 ). The test is commercially available through clinical diagnostic
labs in both the US and UK.

Today, EpiSwitch® CiRT is the focus of an observational registry study in US:
PROWES is a national IRB-approved study of the concordance of CiRT response
prediction to the clinically observed response rate. It will further document
the clinical application and utility of the assay for the treatment of
multiple oncological indications.  PROWES is projected to onboard up to dozen
oncology institutions and enroll up to 2,500 patients. The study is being run
under commercial terms through the CLIA labs in the US.

Dr Kashyap Patel, Oncologist and CEO at Carolina Blood and Cancer Care
Associates, said "Episwitch CiRT is the unique blood-based test that enables
oncologists to identify patients with advanced cancer likely to respond to
Immunotherapy. This is truly an unmet need and will likely improve outcomes,
reduce toxicities and with prospective HEOR studies will establish cost
improvements too.

OBD has recently applied for a New York Department of Health Clinical
Laboratory Evaluation Program (CLEP) New York State (NYS) CLIA license and,
working with its partner lab NeXT Molecular Analytics, has submitted
EpiSwitch® CiRT for NYS DOH CLEP approval. NYS CLEP requires that both the
lab and the assay performed meet the high standards expected for the care and
management of medically vulnerable populations

The EpiSwitch® HiRT (Hyper-Immune Response Test), a unique prognostic blood
test developed with support from the Partnership for Accelerating Cancer
Therapies (PACT, USA), will demonstrate the application of EpiSwitch as an
important companion for patient management. The test accurately predicts
individuals who are most likely to exhibit IO-triggered Hyper-Progressive
Disease (HPD), a response to immunotherapy which triggers life-threatening,
disease-accelerating side effects. An average of 12% of ICI-treated patients
exhibit HPD( 5 ).

OBD will also introduce the EpiSwitch Data Knowledgebase, a database of
greater than 1 billion data points and a suite of proprietary AI algorithms
for in silico modelling of biomarkers and assays.  Application of the
knowledgebase will facilitate development of a multiplex assay for the early
diagnosis of irAEs. OBD has already pioneered the application of its EpiSwitch
platform and microarrays manufactured by Agilent Technologies, Inc to develop
a multi-choice/multiplex array for the early diagnosis of multiple canine
cancers (the EpiSwitch SCB test)( 6 ).  Using a similar approach and test
design, OBD will develop a multiplex Agilent array-based assay for prediction
of the most prevalent side effects in immunotherapy: cutaneous toxicity
(inflammatory dermatitis), musculoskeletal toxicities (inflammatory
arthritis), gastrointestinal toxicities (hepatitis), renal toxicities
nephritis), nervous system toxicity (peripheral neuropathy), endocrine
toxicities (hypophysis and primary hypothyroidism),  hematologic toxicities
(haemolytic anemia) and lung toxicities (pneumonitis).

These new efforts follow on the successful development of prognostic and
predictive biomarkers for prevention of rheumatoid arthritis in collaboration
with Prof. Andrew Cope, Kings College, (APIPPRA trial)( 7 ). The EpiSwitch
platform went beyond the boundaries of disease diagnosis with samples from the
APIPPRA trial to prospectively identify patients who will respond, if treated
prophylactically, in the presymptomatic stage of rheumatoid arthritis
treatment with Abatacept thus minimizing or eliminating irAEs.

Dr Alexandre Akoulitchev, CSO at OBD, said: "Immunotherapy is bringing a
revolution into the field of oncology. Today, as the field has matured and the
real-world data provides us with better guidance on treatment utility, there
is a strong consensus emerging in the application of immunotherapy that we
need to do a better job on selecting biomarkers and developing strong assays.
The highest priority questions lie with biomarker selection and the need for:
1) robust and accurate predictive biomarkers to help identify potential
responders among the majority of non-responders; 2) prognostic biomarkers to
identify patients most likely to suffer IO-triggered Hyper-Progressive Disease
and protect them from harm, 3) diagnostic and prognostic biomarkers to help
correctly identify and manage the multitude of irAEs. The value of such
biomarker insights is recognized today by our industry partners, clinical
oncology clients and government programmes, such as the Cancer Immunotherapy
Response Research Platform (CIRRP) call from the Office for Life Sciences, UK.
Without good biomarkers, the impact of side-effects and socio-economic aspects
of the expensive immunotherapy treatments will outweigh the great benefits
from the high efficacy that these new treatments can offer to the sub-group of
responsive patients. EpiSwitch biomarkers have the potential to make a real
difference in oncological practice. Early real-world evidence from today's US
practice already attests to that".

-Ends-

References

 1  Oxford BioDynamics Plc. (2023). Half-year report. HY results link
(https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1690889)
 
(https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1690889)

 2  Hunter, E., et al. (2023). Development and validation of blood‐based
predictive biomarkers for response to PD‐1/PD-L1 checkpoint inhibitors:
evidence of a universal systemic core of 3D immunogenetic profiling across
multiple oncological indications, Cancers 15(10),
2696. https://www.mdpi.com/2072-6694/15/10/2696
(https://www.mdpi.com/2072-6694/15/10/2696)

 3  Zhao, B.; Zhao, H.; Zhao, J. (2020). Efficacy of PD-1/PD-L1 blockade
monotherapy in clinical trials, Therapeutic Advances in Medical Oncology,
Vol. 12. https://doi.org/10.1177/1758835920937612
(https://doi.org/10.1177/1758835920937612)

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

 5  Park, H. J.; Kim, K. W.; Won, S. E.; Yoon, S.; Chae, Y. K.; Tirumani, S.
H.; Ramaiya, N. H. (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. doi:10.1001/jamanetworkopen.2021.1136
(https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777859)

 6   Hunter, E.,, Salter, M., Powell, R., Dring, A., Naithani, T.,
Vugrinec, D., Shliaiev, K., Issa, M., Weston, C., Hatton, A.,
Gebregzabhar, A., Green, J., Blum, A., Guiel, T., Fritz, S., Seelig, D.,
Modiano, J.F., Akoulitchev, A. (2024) Whole Genome 3D Blood Biopsy Profiling
of Canine Cancers: Development and Validation of EpiSwitch Multi-Choice
Array-Based Diagnostic Test
bioRxiv 2024.05.22.595358; https://doi.org/10.1101/2024.05.22.595358
(https://www.biorxiv.org/content/10.1101/2024.05.22.595358)

 7  Oxford BioDynamics Plc (2024). OBD and King's College London Collaborate
on RA. LSE news link
(https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1820835)
.

 

For more information:

 Oxford BioDynamics Plc                  +44 (0)1865 518910

 Jon Burrows, CEO

 Paul Stockdale, CFO

 Shore Capital                           +44 (0)20 7408 4090

(Nominated Adviser and Broker to OBD)

 Stephane Auton

 Lucy Bowden

 WG Partners                             +44 (0)20 3705 9330

 (Joint Broker to OBD)

 David Wilson / Claes Spång /

Sateesh Nadarajah / Erland Sternby

 Vigo Consulting                         Tel: +44 (0)20 7390 0230
 (Media / Analyst enquiries for OBD)

Rozi Morris                            obd@vigoconsulting.com

 

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
(https://url.avanan.click/v2/___http:/www.94percent.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjphZTRmOjE1ZmE3ZTA1NmFmMzlmYjIzZmFhOGU1NTc5MWI0OTdiODZmMjVmOTFlOWQ2YjBiZTM3YmNmMTMxMGYxOTcxMjI6cDpU)
(EpiSwitch Prostate Screening test) and EpiSwitch® CiRT
(https://url.avanan.click/v2/___https:/www.mycirt.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjpjZGI4OjQ3ZWJmMjU3YzNhNjYzYzNiYWVjZGNlMTJjZDM5ZGZkYzBlNmQyNTc0OTdlZWU4ZGI4ODFlYzU1OWZmN2JmMWE6cDpU)
(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
(https://url.avanan.click/v2/___http:/store.oxfordbiodynamics.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6Njo0ZTU1OjIxYzYwYjMwMmY3Yzg3MzhlMTllY2IyNTRlYWQzMzk5ZWZmMzM2NjMyZTQyYmQwZmEyZDgwY2U0Yjg4M2JkOWU6cDpU)
, 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
(https://url.avanan.click/v2/___http:/www.oxfordbiodynamics.com___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6Njo3YmRiOmUxODM2ZWZhYmIxNjdhMjFiNTMxOThjNjE0YzMwYzg5YzA1MjI2MmYxMGY0ZTU1MzdjYzdlYzg1NDA5ZTcyOWU6cDpU)
, or follow OBD on Twitter
(https://url.avanan.click/v2/___https:/x.com/OxBioDynamics___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjplZWUzOjc5NjFkZGM3Y2Y0ZDI5N2UxMmRlMWViM2UyODQwODYwZWNmMjNiMTM1NTMzMDQ1NDlhYmI3YTMwYjFlNTI3ZDk6cDpU)
(@OxBioDynamics) and LinkedIn
(https://url.avanan.click/v2/___https:/www.linkedin.com/company/oxford-biodynamics___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjozM2I4OmVmNzdkN2M0NmYxZDg3ODc0MWQ1NDEyMGQ4MjAxOWVmMTg4ZTMzNWY4MTA5NGE3NTE5ZDdlNWIwNjI5MTRhMTM6cDpU)
.

 

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.

 

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