Market Newsdesk

PHILADELPHIA, Dec. 15, 2020 (GLOBE NEWSWIRE) —
A team of scientists from The Wistar Institute, INOVIO, AstraZeneca, the Perelman School of Medicine at the University of Pennsylvania, and Indiana University has received a $37.6 million award over two years from the Defense Advanced Research Projects Agency (DARPA) and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) for rapid preclinical development and translational studies of DNA-encoded monoclonal antibodies (DMAbs) as countermeasures for COVID-19.

DMAbs, unlike conventional therapeutic antibodies, are administered as genetic blueprints that instruct the patient’s body to build its own highly specific antibodies against pathogens, such as bacteria and viruses, and as immunotherapeutics for cancer. Conceptually DMAbs have advantages over traditional monoclonal antibodies in scale-up and delivery, which would rapidly benefit large populations.   

Worldwide, more than 72 million people are infected with SARS-CoV-2 and more than 1.6 million have died. The U.S. outbreak alone has resulted in the hospitalization of over 110,000 people. Sixteen million Americans have been infected, and more than 300,000 have died of COVID-19 since the outbreak began.*

Wistar scientists and their collaborators pioneered the development of DMAb technology as a unique asset to combat the COVID-19 pandemic. In addition to their high specificity for the target, DMAbs have important advantages of rapid manufacturing, low cost of production, and temperature-stable storage and distribution. 

The concept of synthetic DMAb technology was originated in the laboratory of David B. Weiner, Ph.D., Wistar executive vice president, director of the Vaccine & Immunotherapy Center, and the W.W. Smith Charitable Trust Professor in Cancer Research. The technology involves the design and delivery of genetic sequences that encode monoclonal antibodies into an optimized DNA platform. This genetic blueprint is then administered to a person so that their own body becomes the production site of highly specific antibodies which, in the case of SARS-CoV-2, target essential parts of the virus. In animal studies, DMAbs have been applied to prevent infection as well as to treat infection.  

“We are thrilled that DARPA and JPEO-CBRND have chosen Wistar to assemble this exceptional team to focus on advancing potential DMAb countermeasures for the SARS-CoV-2 crisis,” said Weiner. “Our team combines many different strengths to advance this approach from the bench to the bedside at lightening speed. We have a strong track record of working together to advance DNA-based solutions into the clinic and look forward to advancing these first-in-human studies as a possible risk mitigation approach for COVID-19.”
This paradigm-shifting award supports a unique public-private collaboration, which includes world-class capabilities in synthetic DNA therapeutics and monoclonal antibody technology. Together, with the support of exceptional clinical and translational teams and a global pharmaceutical company, this multidisciplinary approach is uniquely suited to address the unprecedented global health crisis brought about by COVID-19.

The program goal will be to rapidly design, enhance and scale SARS-CoV-2-specific DMAbs, and move them into laboratory and animal model studies. If successful, this will provide the foundation for rigorous, first-in-human clinical trials. 

“This partnership broadens the scope and application of our DNA medicines platform across the spectrum of needed COVID-19 treatment modalities and opens the door for faster, more cost effective, and scalable production of monoclonal antibody products for other infectious diseases, cancers and other unmet medical needs,” said J. Joseph Kim, Ph.D., president and CEO of INOVIO. “Working with our partners, we are excited about the potential this offers both for situations requiring immediate clinical response and benefit.”

Mark Esser, VP and Head of Microbial Sciences, AstraZeneca, said, “We are excited to combine capabilities with Wistar and this world-class team to evaluate the potential of these DNA-delivered antibodies to impact the way we can respond to prevent and treat infection.”

“This COVID-19 pandemic presents a unique and immediate challenge to the world, one in which DNA treatments have the potential to move us to a future where COVID-19 is much more manageable,” said Pablo Tebas, M.D., a professor of Infectious Diseases at the Perelman School of Medicine at the University of Pennsylvania. “We are eager to build upon previous DMAb research and put it to the test against COVID-19.” 

“We are very excited and honored to be part of this extraordinary team,” said Jesper Pallesen, Ph.D., assistant professor of molecular and cellular biochemistry at Indiana University. “The promise of DMAb technology is huge, and its implementation into our global anti-COVID-19 efforts will leave a resonating and lasting footprint. We are delighted to bring structural biology expertise to the team and to provide atomic-detail evaluation of DMAb technology efficacy mechanisms.” 

Wistar, INOVIO, and the University of Pennsylvania with the Department of Defense and the Coalition for Epidemic Preparedness Innovations (CEPI) are in late-stage studies of a synthetic DNA vaccine for COVID-19. Through the collaboration with JPEO-CBRND, this work is supported by the Office of the Assistant Secretary of Defense for Health Affairs with funding from the Defense Health Agency.

Grant information: Synthetic DNA-encoded monoclonal antibodies (DMAbs) targeting COVID-19, 2020-2022.

*Data from the Johns Hopkins Coronavirus Research Center and The COVID Tracking Project at The Atlantic. 

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The Wistar Institute is an international leader in biomedical research with special cancer, immunology, infectious disease research, and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the United States, Wistar has held the prestigious Cancer Center designation from the National Cancer Institute since 1972. The Institute works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. wistar.org.

About Indiana University Research
IU’s world-class researchers have driven innovation and creative initiatives that matter for 200 years. From curing testicular cancer to collaborating with NASA to search for life on Mars, IU has earned its reputation as a world-class research institution. Supported by $854 million last year from our partners, IU researchers are building collaborations and uncovering new solutions that improve lives in Indiana and around the globe.

Veterans now have access to WATS

^3D

life-saving technology in the VA and community settings

SUFFERN, N.Y., Dec. 15, 2020 (GLOBE NEWSWIRE) — CDx Diagnostics has been awarded GSA Contract #36F79721D0050 for WATS^3D, an AI-powered diagnostic platform developed to identify precancerous cells in the esophagus. WATS^3D is now readily available to hospitals and clinics operated by the Veterans Administration, Department of Defense, Indian Health Services and federal prisons. Starting December 1, access to the WATS^3D catalog and pricelist will be available to federal purchasers via the National Acquisition Center (NAC) and the GSA e-library here.

The Veterans Affairs Federal Supply Schedule (VA FSS) supports the healthcare requirements of the VA and other federal government agencies by providing customers with access to high-quality goods and services at the best commercial rate. As a VA approved contractor, 12.5 million veteran and active-duty members of the Military Health System now have access to the advanced sampling, screening, and analysis that WATS^3D offers with the potential to prevent esophageal cancer.

One of the fastest growing and most fatal cancers in the US, esophageal cancer (EAC) develops from Barrett’s esophagus (BE), an acquired condition that occurs as a result of chronic recurrent acid-induced damage to the internal lining of the esophagus. WATS^3D plays an important role in the early detection and prevention of EAC by using a unique combination of superior sampling, advanced 3D imaging and Artificial Intelligence analysis to determine the presence of BE and esophageal dysplasia in patients undergoing upper endoscopy. In large multicenter clinical trials, WATS^3D has been found to significantly increase the detection rate of both BE and esophageal dysplasia compared to the traditional method of screening – the Seattle Protocol.

“What better way to honor and protect our veterans than to provide them with a life-saving technology,” says CDx Diagnostics CEO Bill Huffnagle. “CDx has worked diligently to create an avenue through which the WATS^3D diagnostic platform can be made more readily available to our active duty military and veterans. We’re excited to be included in the Federal Supply Schedule with an opportunity to provide the evidence-based and cost-effective care of WATS^3D both inside federal healthcare facilities and through the private sector.”

CDx has completed the five major pillars of evidence-based medicine for WATS^3D, including Analytic Validity, Clinical Validity, Clinical Utility, Cost Effectiveness and Recommendations by Major Medical Societies. The technology has earned recognition from the American Society for Gastrointestinal Endoscopy (ASGE), the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the American Foregut Society (AFS).

In 2019, the ASGE included WATS^3D in its Standards of Practice Committee’s guideline for the screening and surveillance of BE. In 2020, the technology was deemed a safe and effective adjunct to forceps biopsies in the evaluation of BE, low-grade dysplasia, and high-grade dysplasia by SAGES and its Technology and Value Assessment Committee (TAVAC).

About WATS

^3D


WATS^3D addresses the major inadequacies inherent in current random forceps biopsy testing of the esophagus. In just a few minutes, endoscopists can easily obtain a wide area, full-thickness transepithelial specimen for computer-assisted 3D laboratory analysis prior to diagnosis by any WATS^3D certified pathologist. In large multicenter clinical trials, WATS^3D has been found to significantly increase the detection rate of both Barrett’s esophagus and esophageal dysplasia. The high sensitivity and inter-observer agreement of WATS^3D is due to the larger tissue area sampled, and the proprietary 3-Dimensional computer imaging system that is based on an artificial intelligence algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program. To learn more about WATS^3D, visit www.wats3d.com.

About CDx Diagnostics

CDx Diagnostics’ mission of Empowering Physicians with Innovative Technology to Prevent Esophageal Cancer, One Patient at a Time is accomplished by a proprietary diagnostic platform that synthesizes computer imaging, artificial intelligence, molecular biology and three-dimensional cytopathology to detect precancerous change earlier and more reliably than prior methods. Routine clinical use of CDx testing has already detected thousands of precancers that would otherwise have been missed in time for effective endoscopic treatment.  Additionally, CDx Diagnostics is looking to apply its next-generation diagnostic platform to prevent cancers of the bile duct, stomach, and colon. CDx Diagnostics is a Galen Partners portfolio company. To learn more, visit www.cdxdiagnostics.com.

Contact: Donnie Turlington

Phone: 336-991-7711

Email: [email protected] 

Denver, Dec. 15, 2020 (GLOBE NEWSWIRE) — Today, the Colorado Community College Foundation announced that The Colorado Health Foundation awarded a $1 million grant to the Colorado Community College System (CCCS) to reshape law enforcement training and better prepare future officers to serve and protect all members of Colorado’s diverse communities. 

The grant will allow CCC’s Law Enforcement Academy Curriculum and Training project team to review current course objectives, program requirements, and instructor techniques to identify opportunities to embed a focus on social justice. The redesigned curriculum will be offered to academy cadets and delivered statewide to current officers. 

An early review of Colorado’s Peace Officer Standards and Training (POST) curriculum indicates that only eight credit hours of the required 556 total credit hours focus on issues of ethics and anti-bias policing. The remaining hours are dedicated to tactical topics and skills such as criminal processes, basic law, driving, and hand-to-hand combat. While all are critical aspects of officer training, CCCS’s project will provide necessary balance specifically in the areas of racial justice, diversity, implicit bias, and de-escalation to better reflect the activities that most officers engage in every day.

“Our commitment to our students and to our communities is to improve lives and increase opportunity through education. We acknowledge that as the state’s largest provider of post-secondary training and workforce education, we have a responsibility to re-examine our law enforcement curriculum that prepares hundreds of new police officers each year,” said Joe Garcia, chancellor of the Colorado Community College System. “We are grateful for this generous support from The Colorado Health Foundation that will help us move our initiative forward and empower us to make a lasting impact on the health and safety of our communities.”

“The Colorado Health Foundation is proud to support this project aimed at transforming local law enforcement training to better reflect, represent and serve Colorado’s diverse communities – particularly folks who have been historically and disproportionately harmed by police violence, such as Black, Latinx, Asian American/Pacific Islander and Native/Indigenous populations,” said Karen McNeil-Miller, president and CEO of The Colorado Health Foundation. “The safety and well-being of everyone in our state is critical to our mission to bring health in reach for all Coloradans. We see this collaborative community effort as a potential game changer, and as one piece of a larger puzzle to create more inclusive, equitable institutions and systems.” 

Partners in this important work to review programs statewide include the Colorado Attorney General’s Office, the POST Board, community organizations such as Urban League of Metropolitan Denver and Colorado Association of Chiefs of Police, and prominent leaders in the community. Higher education partners include Colorado Mountain College, Aims Community College, and Western Colorado Community College. CCCS and these college partners collectively house 11 of the 24 Law Enforcement Academies in the state, all of which are governed by the POST Board, training close to 700 cadets per year.  

The initiative includes three phases. The first phase is a comprehensive review of current law enforcement training programs and development of a new, culturally responsive curriculum. In phase two, instructors will complete training using the new curriculum that includes high impact simulations for explicit training around issues of social justice and racial equity. The second phase also includes intentional efforts to expand the diversity of instructional staff within academies. Culminating the project in phase three is the creation of a second training program for working officers to be delivered through half-day modules or multi-day sessions. The redesigned curriculum is expected to be offered in 2022 to cadets and the new training for officers will be available in 2023. 

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About the Colorado Community College System
 

The Colorado Community College System (CCCS) is the state’s largest system of higher education, delivering more than 1,000 programs to over 125,000 students annually through 13 colleges and 40 locations across Colorado. Our open access mission ensures all Coloradans who aspire to enrich their lives have access to quality higher education opportunities. The System Office provides leadership, advocacy and support to the colleges under the direction of the State Board for Community Colleges and Occupational Education (SBCCOE). Join us in changing the way Colorado goes to college. 

About the 
Foundation for Colorado Community Colleges
 

Founded in 1987, the Foundation for Colorado Community Colleges advances the mission, vision, goals, and objectives of the Colorado Community College System. Specifically, the Foundation actively seeks contributions from public and private sources to make scholarships available statewide, advance key programmatic initiatives, provide training and support for CCCS college foundations, and develop partnerships to implement state of the art programs that meet the workforce needs of the 21st century. 

About 
The 
Colorado Health Foundation
 

The Colorado Health Foundation is bringing health in reach for all Coloradans by engaging closely with communities across the state through investing, policy advocacy, learning and capacity building. For more information, please visit www.coloradohealth.org. 

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• CCCS Law Enforcement Academy Image 2020-12-15 15_21_08

• FDA grants Emergency Use Authorization for Ellume COVID-19 Home Test for non-prescription home use in symptomatic and asymptomatic individuals
• The test demonstrated 96% accuracy in a multi-site US clinical study of both adults and children 2 years and above
• Ellume is ramping up manufacture, with production on track for over 100,000 tests per day in January 2021
  

VALENCIA, Calif. and BRISBANE, Australia , Dec. 15, 2020 (GLOBE NEWSWIRE) — Digital diagnostics company Ellume today announced its rapid, at-home COVID-19 antigen test has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The test will be available for non-prescription home use for the detection of active COVID-19 in individuals with or without symptoms, and in adults and children aged 2 years and above. The Ellume COVID-19 Home Test is the first of its kind to be granted an EUA and provides an essential new tool to help combat the COVID-19 pandemic.

The Ellume self-test will help reduce the spread of COVID-19 through rapid self-detection, providing users with real-time results at home, enabling self-isolation and patient education on escalation of medical care. Alongside the recently authorized COVID-19 vaccine, Ellume’s self-test will provide critical support to the United States as it transitions out of the pandemic, delivering rapid, accurate test results and facilitating a safe return to workplaces, educational institutions, and travel.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” said Ellume founder and CEO, Dr. Sean Parsons. “Ellume’s COVID-19 Home Test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”

With core technology developed over ten years, Ellume’s COVID-19 Home Test combines ground-breaking technology with world-class usability to offer best-in-class at-home digital diagnostics. The self-test works in conjunction with a free software application (app) downloaded on the user’s smartphone, which provides easy-to-read, step-by-step instructions including a how-to-use video. All analysis is performed by the test’s electronic analyzer and using Bluetooth^® connectivity, the test result is displayed on the user’s smartphone in 15 minutes or less.

Clinical Performance

In data submitted to the FDA from an independently run, simulated home-settingclinical study of 198 subjects ranging in age from 2 years to 82 years, the Ellume COVID-19 Home Test demonstrated 96% accuracy, with an overall sensitivity of 95% (positive percent agreement) and specificity of 97% (negative percent agreement) when compared to an emergency use-authorized RT-PCR laboratory test.

In individuals presenting with COVID-19 symptoms, the Ellume COVID-19 Home Test demonstrated a sensitivity of 96% and specificity of 100%, and in asymptomatic individuals, the test demonstrated a sensitivity of 91% and specificity of 96%.

This level of accuracy across both symptomatic and asymptomatic individuals is crucial in mitigating the spread of an infectious disease like COVID-19, which can be spread unknowingly. The clinical study cohort was designed to be widely representative of ages and genders and spanned five testing locations in California, Texas, Alabama, Maryland and Louisiana.

A further independent analytical evaluation was conducted by Emory University, Georgia Institute of Technology, and Children’s Healthcare of Atlanta for the NIH RADx Tech program and determined that of the rapid antigen tests evaluated by the RADx Testing Core at the time, Ellume’s at-home COVID-19 antigen test demonstrated premium performance.

Core Technology

Supercharged fluorescent immunochromatography using a quantum-dot based fluorescent particle

The Ellume COVID-19 Home Test’s core technology combines ultra-sensitive optics, electronics and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology.

The patented detection method detects minute fluorescence signals using unique fluorescent nanoparticles and a sophisticated reader system to achieve accurate results from a clinical sample, overcoming the sensitivity limitations of typical lateral flow technology. The key elements of Ellume’s digital technology reduce the probability of false results, create new pathways to treatment, and optimize secure public health reporting. These unique features are critical to the approval, success and adoption of self-administered home testing.

How it works

Safe, accurate and rapid self-test

The test includes a sterile Nasal Swab, a Dropper, Processing Fluid, and a Bluetooth^® connected Analyzer for use with an app on the user’s smartphone. Utilizing the dedicated app, the user follows step-by-step video instructions to perform the test including a self-collected mid-turbinate nasal swab. The sample is analyzed, and results are automatically transmitted to the user’s smartphone via Bluetooth^® in 15 minutes or less. Results can be shared with healthcare professionals to enable optimal therapy.

Through a secure cloud connection, Ellume’s COVID-19 Home Test can provide real-time reporting of test results to health authorities, employers, and educators, for efficient COVID-19 mapping.

Manufacturing Scale-Up

Ellume has been able to fast-track the development of its range of COVID-19 diagnostic tests with the support of a $30 million WP-2 grant from the U.S. National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) initiative.

In order to meet anticipated demand, Ellume has expanded its manufacturing facility in Brisbane, Australia, the largest of its kind in the Southern Hemisphere, and is rapidly expanding its manufacturing efforts and supply chain within the U.S. Production has already commenced and Ellume will be shipping over 100,000 tests per day from next month. Ellume plans to manufacture and deliver 20 million Ellume COVID-19 Home Tests to the U.S. within the first half of 2021.

About Ellume

Ellume is at the forefront of accurate, rapid and accessible testing that is integral to today’s COVID-19 response and will help ensure the world is prepared for the next infectious disease pandemic. Ellume is a digital diagnostics company that develops, manufactures, and commercializes high-performance, connected products for healthcare professionals and consumers. Ellume’s key focus is on the detection of common infectious diseases which affect the global population across all diagnostic settings; at-home, point-of-care and in-laboratory. Ellume’s suite of products differ from conventional diagnostics through performance, digital connectivity, actionability and simplicity. Its novel detection technology is powered by unique quantum dot nanoparticles and integrates optics, electronics, biologics and software into an intuitive and high-performance digital platform. Ellume has a global consumer health partnership with GlaxoSmithKline, a global COVID-19 and latent TB partnership with QIAGEN, and a range of professional products under its ellume·lab brand. Ellume is committed to developing high-quality digital diagnostics that the world can rely on in a health crisis.

Further information can be found at ellumehealth.com.

This project has been funded in part by the NIH RADx initiative with US federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. 75N92020C00034. Ellume acknowledges the great assistance of the NIH in making practical Covid19 rapid testing an effective reality.

The Ellume COVID-19 Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for non-prescription home use. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Photos accompanying this announcement are available at: 

https://www.globenewswire.com/NewsRoom/AttachmentNg/31ab89ab-d16d-4142-bf8d-7972c2dd19a5

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