Dystonic Disorders

OXFORD, England--( BUSINESS WIRE )--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.” References [1] Oxford BioDynamics Plc. (2023). Half-year report. HY results link [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 [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 [4] Oxford BioDynamics Plc. (2022). EpiSwitch CiRT. 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 [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 [7] Oxford BioDynamics Plc (2024). OBD and King’s College London Collaborate on RA. LSE news link . 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 (EpiSwitch Prostate Screening test) and EpiSwitch ® CiRT (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 , 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 , 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 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.

Accelerate the Cure for Vision Loss and Blindness from Diabetes; 530 Million People Worldwide at RiskThe Mary Tyler Moore Vision Initiative has produced their first PSA campaign to galvanize the public to support the advancement of medical research to preserve and restore vision in people with diabetesNarrated by Kevin Kline, this PSA includes remarks by Julia Louis-Dreyfus, Oprah Winfrey and Reese Witherspoon and is directed by Academy Award-nominated filmmaker James Keach LOS ANGELES, July 16, 2024 /PRNewswire/ -- Today, the Mary Tyler Moore Vision Initiative (MTM Vision) has launched their first Public Service Announcement (PSA) campaign. Created to honor the iconic actress Mary Tyler Moore, MTM Vision seeks to make Mary's dream of a world without vision loss and blindness from diabetes come true. MTM Vision's PSA educates the public about the critical need for medical research to find ways to better treat and cure diabetic retinal disease (DRD) and related vision loss and blindness from diabetes. Today, more than 530 million people worldwide with diabetes are at risk for DRD. Mary Tyler Moore Vision Initiative PSA: The Sight You Save May Be That of Someone You Love

New Study Offering Free Plagiocephaly Treatment (an alternative to helmet therapy) in San Diego, California! SAN DIEGO, March 27, 2024 /PRNewswire/ -- The Osteopathic Center for Children & Osteopathy's Promise to Children is now looking for infants 4 months old and younger diagnosed with plagiocephaly (flat head syndrome), which affects 47% of infants in the US. If left untreated, this can cause vision problems, muscular tightness, dental issues, & developmental delays. Qualified infants who enroll in this study will receive gentle, hands-on treatment known as Osteopathic Manipulative Treatment (OMT), which has been proven to address the underlying cause of plagiocephaly, reducing its impact on the child's development more than current treatments, such as helmet therapy. Continue Reading If you think that your child has plagiocephaly/flat head syndrome, reach out to see how you can participate in the study. You may qualify for free Osteopathic Manipulative Treatment (OMT) and up to $550 in compensation! "We use OMT to evaluate & treat the whole body, not just one area of concern. Parents who have brought their children for OMT have seen incredible results. Often when treating them for plagiocephaly, we also see improvement in other conditions such as feeding problems, colic, poor sleep, spitting up, and torticollis (tight neck muscles)," says Dr. Kimberly Wolf, DO, FAAP, FACOP, FAAPO who is one of the leaders in the field of pediatric osteopathic medicine. Parents or referring doctors can visit for more information. About Plagiocephaly Plagiocephaly, known as flat head syndrome, is a condition where an infant's head becomes flattened on one side. Torticollis is characterized by tight neck muscles, restricting an infant's ability to turn their head. Plagiocephaly & torticollis diagnoses have risen nearly 600% since the launch of the Back to Sleep Campaign to reduce Sudden Infant Death Syndrome (SIDS)/Sudden Unexpected Infant Death (SUID) in 1992. It is estimated that ~47% of 3-month-olds may have plagiocephaly. Currently, plagiocephaly management may involve repositioning or wearing a corrective helmet for several months, which mainly addresses the cosmetic aspect of plagiocephaly. About OMT Both published & anecdotal evidence support the success of OMT. A 2023 study in the Journal of Osteopathic Medicine shows that following OMT treatments, there was a statistically significant decrease in the measure of skull asymmetry & head flattening. Additionally, the mom of a patient treated by Dr. Wolf shared, "My child had plagiocephaly as an infant. We were able to bypass having to use a helmet by taking him for OMT treatments & an amazing D.O. OMT is a WONDERFUL thing." The Benefits of OMT: - Administered by a physician. - Non-invasive and gentle. - Evaluates and treats the whole body, not just the head. About the OPT-IN Study The OPT-IN research study provides an alternative to helmet therapy. It hopes to show significant improvements in children receiving OMT compared to repositioning (at-home exercises) in children diagnosed with plagiocephaly. How to Enroll in the Study Healthcare providers in San Diego, CA, who have patients with plagiocephaly should refer families to OPT-IN for screening. Parents who are concerned about the shape of their child's head or whose child has plagiocephaly should contact OPT-IN for more information & to see if they qualify for the study. Children receive treatment in the study free of charge, and families will be compensated up to $550 for their participation. About Us: The Osteopathic Center for Children (OCC) aims to enhance children's well-being through holistic, patient-centered care and to promote osteopathic principles in pediatric medicine. Our mission includes research, education, & supporting physicians in providing osteopathic care to children & families. Social media: Facebook: LinkedIn Media Contact: Kimberly Wolf, DO Osteopathic Center for Children Osteopathy's Promise to Children Phone: 619-693-6303 Email: [email protected] SOURCE Osteopathy’s Promise to Children