BEAT19 crowd-sourcing study jump starts data collection for research to find effective treatments in battle against COVID-19

240 million Americans can play a vital role in the search for a vaccine or treatment by contributing critical data from home

SAN FRANCISCO – April 15, 2020 – xCures, a health technology company focused on the use of artificial intelligence, has released preliminary data from the company’s Behavior, Environment, And Treatments for COVID-19 (BEAT19) registry study, NCT04321811.  The study is designed to enable everyday people, regardless of their health status, to contribute directly to the development of coronavirus treatments. Since the approval of the BEAT19 registry by the Genetic Alliance’s independent review board (IRB) and program launch on March 29, BEAT19 has collected more than 6,000 daily surveys representing people across all 50 US states and several countries. The preliminary data demonstrated that BEAT19 can collect data from patients who are infected with COVID-19 while they are undergoing quarantine and provide clinical researchers with important insights into disease progression.

Most people will combat and recover from COVID-19 in their homes, isolated from their friends and family. Much of the information being collected today by the healthcare system when a person is interacting with their care team, leaving most data until that point unreported. BEAT19 is a way to learn about what is happening to the millions of people who experience COVID-19 outside a hospital. The BEAT19 data will be used to define the natural history of infection and to look for patterns, formulate and test hypotheses. For example, do people with high blood pressure who contract COVID-19 and take an ACE inhibitor fare better than people who take a beta blocker?

“The BEAT19 online trial has the potential to improve our understanding of COVID-19 and help public health experts make evidence-based decisions,” said Vikash Mansinghka, PhD, principal research scientist and principal investigator of the MIT Probabilistic Computing Project. “The data could inform critical research decisions, smooth the path for developing a vaccine, and reveal potential therapeutic options for COVID-19 patients and the healthcare professionals caring for them.”

“Our team has taken an initial look at the BEAT19 data and were able to quickly screen for anomalies. As BEAT19 enrollment grows, we may be able to identify early signals about risk factors and clinical presentations that can be confirmed or corrected by doctors,” added Ulrich Schaechtle, PhD, xCures-MIT BEAT19 collaboration research lead and MIT Probabilistic Computing Project scientist.  “The ability to rapidly assess the data accumulated in the registry means researchers can account for additional factors in their research for a vaccine and treatment, which is critical as the world races to find a solution for the millions of people affected by the COVID-19 pandemic.”

BEAT19 is designed to capture how people are feeling and learn from their experiences during COVID-19.  To really understand the infection, it is necessary to start tracking symptoms before people are diagnosed, to establish a baseline.  During the illness, many BEAT19 participants are taking medications for their ongoing conditions and some appear be taking novel treatments, such as Hydroxychloroquine (HCQ) + azithromycin. The registry is gathering and analyzing real-time information from real people about their daily COVID-19-related experiences. This approach is a proven and very efficient way to generate real-world effectiveness data on emerging therapies that can help guide clinical research.

“The ability to effectively crowd-source data in an effort to solve a global pandemic is proof of the impact health technology and innovation can have on our world,” said Erica Frank, MD, MPH, FACPM, Professor and Canada Research Chair in Preventive Medicine and Population Health, University of British Columbia:  “While the threat of COVID-19 continues, people can participate in finding a cure while practicing physical distancing and sheltering at home.  People-powered research can move faster than traditional approaches and bring together significant new insights from different areas of expertise to solve a massive global health problem.  It’s truly inspiring, and we are proud to volunteer for this effort.”

People, regardless of their current health status, can join BEAT19 by completing a simple enrollment survey and agreeing to participate through the study’s website. The data collected is de-identified to keep the data secure and private, then it is made available as a resource for researchers. As more biopharmaceutical companies begin researching COVID-19 vaccines and therapies, they need to access to vital disease-progression information that is usually only captured by care providers.

“In this unprecedented time, we need to move with urgency to focus resources where they will help people immediately,” said Mika Newton, chief executive officer of xCures, Inc. “Simply put, we knew researchers needed more and early data about COVID-19.  Our team recognized the possibility to apply our experience in accelerating clinical research to the battle at hand, and that doing this quickly could save many lives. The sooner we can answer the many open and important questions about COVID-19, the sooner we can get to our new normal. There is no cost to participate, and registrants can be proud that they acted and played their part in the clinical research needed to combat COVID-19. Together let’s Beat19!”

To join the fight against COVID-19, please visit the BEAT19 registry website at www.BEAT19.org  where you can find out more information about the study and can register to participate as a contributor or request information as a researcher.

About the BEAT19 Registry Study

BEAT19 is a people-powered study, registered on clinicaltrials.gov, designed to understand the natural history of the coronavirus infection before, during and after symptoms, and to understand how pre-existing conditions, medications, and other factors affect disease progression. The BEAT19 registry is used to gather knowledge about new treatments faster than can be done in clinical trials. Participants are everyday people, who might or might not have COVID-19. They all provide confidential data, using a short daily survey sent via email.

If new knowledge (a signal) emerges from the data, then participants whose data contributed to the signal may be contacted for approval to request additional information. This is only done if the knowledge merits deeper exploration.

For more information, or to participate in the study, please visit https://beat19.org/.

About xCures

xCures is a health technology and services company that operates an AI-assisted precision medicine platform that continuously learns from the experiences of all patients, on all treatments, all the time. The platform can determine the best individualized treatment options and services for patients, including access via reimbursement, clinical trials, and expanded-access support. By tightly integrating research and clinical care, xCures enables physicians to make better treatment decisions, patients to achieve superior outcomes, and bio-pharmas to slash the time and cost of developing drugs.

Oncology Pioneer xCures Names Experts to Advisory Boards

Prominence of Scientific and company Advisory Board signals attraction to xCures’ novel patient-centric approach to treatment and continuous learning for cancer

LOS ALTOS, CA, USA, October 10, 2019 — Today, xCures Inc. announced the appointment of members to its Scientific Advisory Board (SAB) and company Advisory Board. The SAB supports the work of xCures’ Virtual Tumor Boards in running patient-centered Perpetual Clinical Trials for oncology. xCures currently manages XCELSIOR, a Perpetual Trial collecting real-world data and patient-reported outcomes integrated with AI- and expert-supported Virtual Tumor Boards.
The company Advisory Board provides guidance to the company on technology and business issues. By implementing this precision oncology approach to the treatment of all cancer patients, on all therapies, all the time, xCures aims to develop deep insights into rapid improvements in the treatment of cancer patients.

Integrating Clinical Research And Care In A Perpetual Trial

With attention focused on the difficulties associated with traditional oncologic clinical trials, xCures’ Perpetual Trial and the potential for a Real World Data-based learning ecosystem has gained attention. Recently, Diagnostic World News interviewed xCures CEO Mika Newton about Perpetual Trials, AI, and the future of accelerating treatment and knowledge in the development of cancer treatments. To see more, go to Diagnostic World News.

Oncology Expert Keith T. Flaherty, MD Named Chairman of xCures Scientific Advisory Board

Keith T. Flaherty, MD, has joined the xCures Scientific Advisory Board as Chairman. The Scientific Advisory Board supports the work of xCures’ Virtual Tumor Boards in running patient-centered “Perpetual Trials” for oncology. xCures currently runs XCELSIOR, a Perpetual Trial integrating real-world data and patient-reported outcomes with an AI-enhanced Virtual Tumor Board. By implementing this precision oncology approach to the treatment of all cancer patients, on all therapies, all the time, xCures aims to develop deep insight into rapid improvements in the treatment of cancer patients.

“Keith Flaherty brings unparalleled experience in targeted therapy and will be an invaluable addition to the essential activities of our Scientific Advisory Board as more and more we bring real world evidence and patient-centered approaches to research to bear for patients in their fights against cancer,” said Mika Newton, CEO of xCures.

The xCures Scientific Advisory Board’s efforts include developing a portfolio of leading drugs for each of the major molecular mechanisms/pathways driving cancer and providing these options as input for xCure’s Virtual Tumor Boards to consider when formulating treatment options for cancer patients and their doctors. In conjunction with the Advisory Board, xCures works to establish relationships with the manufacturers of those drugs to make them part of the company’s compassionate access compendium. This makes these options more readily available to patients and their physicians. The Scientific Advisory Board will also consider outside entities submitting their hypotheses or therapies as treatment options for considerations by the Virtual Tumor Boards.

“Defeating cancer demands new approaches that both capture and disseminate treatment information broadly and efficiently,” said Dr. Flaherty. “These approaches must take into account the fact that there are far too many rational treatments to try and that traditional trials are far too expensive. I am thrilled to work with xCures as they further develop a revolutionary platform that can rapidly evaluate new therapeutic options at a fraction of the time and cost of traditional trials.”

Keith Flaherty, MD, is Professor of Medicine at Harvard Medical School and Director of Clinical Research at the Massachusetts General Hospital Cancer Center, where he was named as the Richard Saltonstall Endowed Chair in Oncology.

Press Release

xCures to Implement an Intermediate Size Expanded Access Protocol for ONC201 in H3 K27M-Mutant Gliomas

LOS ALTOS, Calif., March 12, 2019 /PRNewswire/ — xCures and Cancer Commons are pleased to announce a collaboration with Oncoceutics to implement an Expanded Access program for ONC201. Part of this Expanded Access program is an intermediate size Expanded Access protocol for ONC201 in patients with H3 K27M-mutant glioma entitled “ONC018: Expanded Access to ONC201 for Patients with H3 K27M-mutant and/or Midline High Grade Gliomas” that was recently accepted by the U.S. Food and Drug Administration (FDA).

The H3 K27M mutation has been identified as an important prognostic indicator in aggressive midline gliomas that involve specific parts of the brain, including the thalamus, pons, or spinal cord. In 2016, the World Health Organization categorized any midline brain tumor that contains the H3 K27M mutation as the highest grade (IV) because the mutation confers such a poor prognosis. Beyond palliative radiation, no medical therapy has been shown to provide clinical benefit for patients with this mutation in their tumor. Pediatric patients are particularly impacted by this mutation, especially those with DIPG where 70-80% of the patients have the mutation.

Press Release