University Hospital Southampton NHS Foundation Trust

SAN DIEGO--( BUSINESS WIRE )-- ClearNote Health , a company focused on improving early detection for some of the deadliest cancers, today announced a new collaboration with research teams in Southampton in the United Kingdom. Researchers at the Southampton Clinical Trials Unit, based at the University of Southampton, will use the ClearNote Health Avantect® Pancreatic Cancer Test in a landmark study, sponsored by University Hospital Southampton NHS Foundation Trust, that builds on the well-established relationship between pancreatic cancer and type 2 diabetes. The prospective, multicenter study will be the largest of its kind, including up to 15,000 patient participants recently diagnosed with type 2 diabetes. While early detection has vastly improved survival rates for many types of cancer, pancreatic cancer is often diagnosed at an advanced metastatic stage when patients have a five-year survival rate as low as 3%. 1 The Avantect test is a blood-based assay designed to use key epigenomic and genomic signals to detect the earliest indicators of pancreatic cancer. It is targeted for use in populations at high risk of developing this type of cancer. One of those populations includes patients with newly diagnosed type 2 diabetes, who are nearly eight times as likely to develop pancreatic cancer as the general population. 2 While the exact relationship between these diseases is not yet fully understood, it is thought that in a small percentage of people newly diagnosed with type 2 diabetes, the symptoms may actually be caused by cancer affecting the function of the pancreas, which is responsible for insulin production. A large proportion of patients with pancreatic cancer have either newly diagnosed type 2 diabetes or longstanding diabetes. 3 The new Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study aims to determine whether pancreatic cancer signals are present in patients who were recently diagnosed with type 2 diabetes. Led by Zaed Hamady, a consultant surgeon specializing in pancreatic cancer at the University Hospital Southampton, the single-blinded, interventional, randomized, controlled study will provide valuable information about the integration of early pancreatic cancer detection and ongoing surveillance in new-onset type 2 diabetes care. It will also expand the clinical validity and utility of the Avantect test in a high-risk patient population. The study is scheduled to begin with a pilot phase in the first quarter of 2025. “Unfortunately, the majority of pancreatic cancer cases are detected very late, when treatment options are limited,” said Mr. Hamady. “We hope that this large study will confirm the Avantect test’s ability to detect the cancer at an early stage, so treatment can begin quickly, which should lead to much better outcomes and possible curative treatment for patients.” “Our trials unit has expertise in running large studies to evaluate new and innovative early detection tests for diseases where we know late diagnosis means poorer outcomes for patients,” said Dr. Victoria Goss, Head of Early Diagnosis and Translational Research at the Southampton Clinical Trials Unit. “We are excited to be collaborating with ClearNote Health and Mr. Hamady’s team to carry out the SAFE-D study and hope it can lead to better diagnosis and treatment for pancreatic cancer patients in the future.” “We are excited to be sponsoring this cutting-edge study with potential benefit to patients with this devastating disease,” said Dr. Mikayala King, Research and Development Governance, Quality Assurance and Sponsorship Manager at University Hospital Southampton NHS Foundation Trust. “We are happy to be working with ClearNote and to be building on our long-established relationship with the CTU to manage and deliver the project.” The Avantect Pancreatic Cancer Test is a simple blood test for patients at high risk of pancreatic cancer, including those newly diagnosed with type 2 diabetes who are at least 50 years old, as well as those with a family history and/or a genetic predisposition. It was designed to detect pancreatic cancer in its earliest stages by profiling the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA and combining that data with other genomic information. Unlike conventional methods, ClearNote’s 5hmC-based approach provides a deeper understanding of the underpinnings of cancer development with an unprecedented level of clarity to inform the next steps in a patient care pathway. “Early cancer detection can be the difference between life and death, but clinicians are too often constrained by the limitations of existing diagnostic technologies,” said Samuel Levy, PhD, Chief Scientific Officer at ClearNote Health. “Today, pancreatic cancer is a devastating diagnosis, but early detection could make a world of difference for these patients. ClearNote Health is focused on transforming the patient care paradigm with a new epigenomics-based approach that allows clinicians to detect and monitor cancers at a more treatable stage so patients can live longer, healthier lives.” For more information on the Avantect Pancreatic Cancer Test, please visit www.avantect.com . About ClearNote Health ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company’s patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. The company’s highly sensitive, noninvasive Avantect® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health’s headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on X or LinkedIn . References 1. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. 2. Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi: 10.1016/j.gastro.2005.05.007. 3. De Souza A, Irfan K, Masud F, Saif MW. Diabetes Type 2 and Pancreatic Cancer: A History Unfolding. JOP. 2016 Mar;17(2):144-148.

NEW YORK, Sept. 15, 2023 /PRNewswire/ -- Up to an hour after their hearts had stopped, some patients revived by cardiopulmonary resuscitation (CPR) had clear memories afterward of experiencing death, and had brain patterns while unconscious linked to thought and memory. This is the finding of a study led by researchers at NYU Grossman School of Medicine, in cooperation with 25 mostly U.S. and British hospitals, in which some survivors of cardiac arrest described lucid death experiences that occurred while they were seemingly unconscious. Despite immediate treatment, fewer than 10 percent of the 567 patients studied, who received CPR in the hospital, recovered sufficiently to be discharged. Four in 10 of those that survived, however, recalled some degree of consciousness during CPR not captured by standard measures. Published online September 14 in the journal Resuscitation, the study also found that in these patients, nearly 40% had brain activity that returned to normal, or nearly normal, at points even an hour into CPR. As captured by EEG, a technology that records brain activity with electrodes, the patients saw spikes in the gamma, delta, theta, alpha, and beta waves associated with higher mental function. Survivors have long reported having heightened awareness and powerful, lucid experiences, say the study authors. These have included a perception of separation from the body, observing events without pain or distress, and a meaningful evaluation of their actions and relationships. The new work found these experiences of death to be different from hallucinations, delusions, illusions, dreams, or CPR-induced consciousness. The study authors hypothesize that the "flatlined," dying brain removes natural inhibitory (braking) systems. These processes, known collectively as disinhibition, may open access to "new dimensions of reality," they say, including lucid recall of all stored memories from early childhood to death, evaluated from the perspective of morality. While no one knows the evolutionary purpose of this phenomenon, it "opens the door to a systematic exploration of what happens when a person dies." "Although doctors have long thought that the brain suffers permanent damage about ten minutes after the heart stops supplying it with oxygen, our work found that the brain can show signs of electrical recovery long into ongoing CPR," says senior study author Sam Parnia, MD, PhD, an associate professor in the Department of Medicine at NYU Langone Health. "This is the first large study to show that these recollections and brain wave changes may be signs of universal, shared elements of so called near-death experiences." These experiences provide a glimpse into a real, yet little understood dimension of human consciousness that becomes uncovered with death, adds Parnia, who is also director of critical care and resuscitation research at NYU Langone. The findings "may also guide the design of new ways to restart the heart or prevent brain injuries, and hold implications for transplantation." Called the AWAreness during REsuscitation (AWARE)-II study – it followed 567 men and women who suffered cardiac arrest during hospital stays between May 2017 and March 2020 in the United States and United Kingdom. Of the 567 patients, only 85 were monitored via EEG to measure brain waves during their experiences. The researchers first presented the study findings at a resuscitation science symposium, part of the American Heart Association's Scientific Sessions 2022 in Chicago on November 6. Only hospitalized patients were enrolled to standardize the CPR and resuscitation methods used, as well as recording methods for brain activity. Additional testimony from 126 community survivors of cardiac arrest with self-reported memories were also examined to provide greater understanding of the themes related to the recalled experience of death. The study authors conclude that research to date has neither proved nor disproved the reality or meaning of patients' experiences and claims of awareness in relation to death. They say the recalled experience surrounding death merits further empirical investigation, and plan to conduct studies that more precisely define biomarkers of clinical consciousness, and that monitor the long-term psychological effects of resuscitation after cardiac arrest. Funding and support for the study was provided by NYU Langone, The John Templeton Foundation, and the Resuscitation Council (UK) and National Institutes for Health Research in the United Kingdom. Along with Parnia, other NYU Langone study investigators were Tara Keshavarz Shirazi, BA; Caitlin O'Neill, MPH; Emma Roellke, MD; Amanda Mengotta, MD; Thaddeus Tarpey, PhD; Elise Huppert, MD; Ian Jaffe, BS; Anelly Gonzales, MS; Jing Xu, MS; and Emmeline Koopman, MS. Other study investigators are Deepak R. Pradhan, MD, at NYC Health + Hospitals/Bellevue in New York City; Jignesh Patel, MD; Linh Tran, MD; Niraj Sinha, MD; and Rebecca Spiegel, MD, at Stony Brook University; Shannon Findlay, MD, at the University of Iowa; Michael McBrine, MD, at Tufts University; Gavin Perkins, MD, at the University of Warwick in Coventry, United Kingdom; Alain Vuylsteke, MD, at Royal Papworth Hospital National Health Service (NHS) Foundation Trust in Cambridge, United Kingdom; Benjamin Bloom, MD, at Barts Health NHS Trust in London, United Kingdom; Heather Jarman, RN, at St. George's University Hospitals NHS Foundation Trust in London; Hiu Nam Tong, MD, at Queen Elizabeth Hospital King's Lynn NHS Foundation Trust in King's Lynn, United Kingdom; Louisa Chan, MD, at Hampshire Hospitals NHS Foundation Trust in Hampshire, United Kingdom; Michael Lyacker, MD, at Ohio State University; Matthew Thomas, MD, at University Hospitals Bristol and Wexton NHS Foundation Trust in Bristol, United Kingdom; Veselin Velchev, MD, at St. Anna University in Sofia, Bulgaria; Charles Cairns, MD, at Drexel University; Rahul Sharma, MD, at Weill Cornell Medicine; Erik Kulstad, MD, at the University of Texas Southwestern; Elizabeth Scherer, MD, at the University of Texas San Antonio; Terence O'Keeffe, MD, at Augusta University; Mahtab Foroozesh, MD, at Virginia Tech; Olumayowa Abe, MD, at NewYork-Presbyterian; Chinwe Ogedegbe, MD, at Hackensack University; Amira Girgis, MD, at Kingston Hospital NHS Foundation Trust in Surrey, United Kingdom; and Charles Deakin, MD, at University Hospital Southampton NHS Foundation Trust in Southampton, United Kingdom. CONTACT: Gregory Williams [email protected] SOURCE NYU Langone Health System

WESTON, Fla.--(BUSINESS WIRE)-- iLiAD Biotechnologies LLC (ILiAD), a clinical stage biotech company developing the world’s most advanced next generation pertussis vaccine announces positive primary data outcomes in the CHAMPION-1 clinical trial conducted at University Hospital Southampton (UK) and University of Oxford (UK). ILiAD Biotechnologies reported today that its BPZE1 intranasal pertussis vaccine has met the primary endpoint of protection against nasopharyngeal B. pertussis colonization (p=0.03) in the Phase 2b CHAMPION-1 Study. This pre-specified sensitivity analysis included participants challenged with sufficient colony forming units (CFUs) of 5 x104 – 2.4 x105 CFUs of wild-type B. pertussis in the per-protocol adequate challenge inoculum group. BPZE1 was well tolerated with most participants experiencing no or mild systemic and nasal/respiratory symptoms of short duration with no serious adverse events. Notably, a post hoc analysis of quantitative B. pertussis CFU counts estimated that BPZE1 vaccination reduced the burden of B. pertussis by 98.0% compared with placebo. The CHAMPION-1 Phase 2b Human Challenge study is a randomized, double-blind, placebo-controlled study of BPZE1 vaccine in healthy adults. The study has a primary objective to demonstrate that prior immunization with BPZE1 protects against colonization as evidenced by negative B. pertussis culture following virulent B. pertussis challenge 2–4 months after vaccination. Additional objectives include demonstration of safety, nasal mucosal and serum immunological response, functional serum bactericidal activity, and reduction in overall bacterial load following virulent B. pertussis challenge. The study included vaccination of 53 participants at University Hospital Southampton and University of Oxford in the United Kingdom, with 46 participants inoculated with a targeted 105 CFU of virulent B. pertussis 2–4 months after vaccination, followed by a 16-night stay in a quarantined challenge facility where nasal mucosal and blood samples were collected. All study participants were treated with antibiotics before leaving quarantine. Chief investigator for the CHAMPION-1 study Prof. Robert Read, Professor and Chair of Infectious Diseases at the University of Southampton stated, “This study marks the first-ever demonstration of a pertussis vaccine preventing B. pertussis colonization in a human challenge model. BPZE1’s ability to induce sterilizing mucosal immunity and prevent B. pertussis colonization at all post-challenge timepoints in most participants is a high bar to have achieved, especially given the substantial challenge dose.” Study Highlights Results indicate that BPZE1 vaccine protects against B. pertussis colonization, as demonstrated by both the primary endpoint of the proportion of participants with no colonization post-challenge in the per-protocol adequate inoculum group and the substantial reduction in overall B. pertussis bacterial load. BPZE1 vaccination induced potent serum bactericidal activity, especially against a pertactin-deficient (PRN-) B. pertussis strain, in contrast to placebo controls. PRN- B. pertussis is currently the predominant circulating strain of B. pertussis in the U.S., which has been identified by CDC researchers to have emerged due to antigen drift in response to the use of current acellular pertussis vaccines. BPZE1 vaccination induced broad nasal mucosal and serum antibody responses which were absent from placebo controls, consistent with both nasal mucosal and systemic protection. The overall frequency of vaccine-related treatment-emergent adverse events was comparable between the BPZE1 and placebo groups, and there were no unexpected safety findings in the BPZE1 group. Stephanie Noviello, MD, ILiAD Chief Medical Officer remarked, “The dramatic reduction in quantitative CFU counts in BPZE1 vaccinated participants compared to placebo, over the duration of post-challenge days, reinforces the potential clinical benefit of BPZE1, confirming previously published BPZE1 results in preclinical and attenuated human challenge studies. This study was intended to inform the primary endpoint, study parameters, and sample size to power a successful Phase 3 B. pertussis human challenge study, which we are confident has now been achieved. The primary data from the CHAMPION-1 clinical study will be presented at the World Vaccine Congress on October 19th in Barcelona.” Keith Rubin, M.D., Chief Executive Officer and Founder, commented, “These results represent a major milestone in global public health efforts to control Bordetella pertussis, a pathogen that harms tens of millions of people each year, especially children who account for the great majority of resulting deaths (over 150,000 annually). For more than a decade, ILiAD has been committed to stopping B. pertussis where it lives – the human upper respiratory tract. We’ve always believed that preventing nasopharyngeal colonization will prevent the subsequent disease, transmission and epidemics that have plagued humanity for hundreds of years. We still have a lot of work to do, but this is far and away the best evidence to date that we can fulfill our mission to eradicate all disease due to B. pertussis. My deep appreciation to everyone who contributed to this study, especially the study participants without whom achievement of this important milestone would not be possible.” Of note, early in study enrollment a small group of participants were identified to have received a lower dose of wild-type B. pertussis challenge than was originally specified in the protocol. As a result, the preparation method of the B. pertussis challenge dose was modified to achieve the per-protocol adequate inoculum of B. pertussis challenge as specified in the original study protocol. In an analysis of all study participants, including those who received the lower challenge dose, the primary endpoint showed a comparable trend of BPZE1 prevention of colonization. About Pertussis Pertussis (whooping cough) is a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis. According to U.S. Centers for Disease Control and Prevention, each year pertussis affects approximately 16 million people globally, accounting for nearly 200,000 deaths. Although estimated global vaccination coverage is 84%, current vaccines have failed to control epidemics. In addition, current vaccines do not fully protect infants under age 6 months, since immunization requires multiple injections, usually at 2, 4 and 6 months. About BPZE1 BPZE1 is a next-generation live-attenuated pertussis vaccine designed to induce comprehensive and durable protection against B. pertussis infection (colonization) and disease (whooping cough). BPZE1 is being developed to block B. pertussis from colonizing adult and adolescent nasal passages, to protect adults and adolescents from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and adolescents and to indirectly protect vulnerable infants, future development aims to immunize neonates directly. BPZE1 was developed at the Institut Pasteur de Lille (France) in the lab of Camille Locht and Nathalie Mielcarek. About ILiAD Biotechnologies, LLC ILiAD Biotechnologies ( ) is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis. The company is developing and acquiring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials. About University Hospital Southampton University Hospital Southampton NHS Foundation Trust (UHS) is one of the largest acute teaching trusts in England with a turnover of more than £1.15 billion in 2021/22. UHS provides hospital services for 1.9 million people living in southern Hampshire and specialist services to more than 3.7 million people in central southern England and the Channel Islands. UHS is consistently one of the UK's highest recruiting trusts of patients to clinical trials and in the top ten nationally for research study volume as ranked by the NIHR Clinical Research Network. In partnership with the University of Southampton, UHS has £35 million of NIHR infrastructure dedicated to bringing the latest treatments to patients. About University of Oxford Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the seventh year running, and number 2 in the QS World Rankings 2022. At the heart of this success are the twin-pillars of our ground-breaking research and innovation and our distinctive educational offer. Oxford is world-famous for research and teaching excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research alongside our personalised approach to teaching sparks imaginative and inventive insights and solutions. Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full time jobs. About the Oxford Vaccines Group – Medical Science Division The Oxford Vaccine Group (OVG) conducts studies of new and improved vaccines for children and adults and is based in the Department of Paediatrics at the University of Oxford. The group is led by Professor Andrew J Pollard. OVG was founded in 1994 by Professor E. Richard Moxon. The multidisciplinary group, led by Professor Pollard since 2001, includes consultants in vaccinology, a Director of Clinical Trials, a Senior Clinical Trials Manager, adult and paediatric clinical research fellows, adult and paediatric research nurses, project managers, statisticians, QA manager, Clinical Trials IT and Development Lead, and an administration team. Our team also includes post-doctoral scientists, research assistants and DPhil students and we work together with professionals from a range of specialities such as immunologists, microbiologists, epidemiologists, health communicators, and a sociologist, a community paediatrician, the local Health Protection team and a bioethicist. “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. In addition to historical facts or statements of current, this press release may contain forward-looking statements. Forward-looking statements provide ILiAD’s current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products, interpretation of clinical results, prospects for regulatory approval, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, rapid technological change, risks associated with acquisitions and investments, risks associated directly with BPZE technologies including but not limited to uncertainties of product development, and uncertainties of clinical development, dependence on third parties, competition, protection of patents and proprietary technology, potential for infringement and other statements regarding matters that are not historical fact. Some of these forward looking statements may be identified by use of words in the statements such as “estimate,” “intend,” or other words and terms of similar meaning. Statements in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore actual outcomes and results may differ materially from what is expressed in such forward-looking statements. ILiAD cautions investors not to place reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this release and ILiAD undertakes no obligations to update or review these statements, except as may be required by law.