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Imanis Life Sciences to Present IMMUNO-COV, a First-in-Class Neutralizing Antibody Test for COVID-19, at American Society of Gene and Cell Therapy Symposium

High-throughput clinical assay detects, quantifies SARS-CoV-2-neutralizing antibodies

Imanis Life Sciences is an affiliate of Vyriad Inc.

ROCHESTER, Minn., September 14, 2020 – Imanis Life Sciences, LLC announced today upcoming presentations about the development and validation of IMMUNO-COV™, the first scalable, quantitative neutralizing antibody test for COVID-19. The company will present a technical overview of the assay and host a luncheon presentation at the American Society of Gene and Cell Therapy (ASGCT) COVID-19 Symposium, a virtual event that will be held September 15-16.

In contrast to other antibody tests, the IMMUNO-COV assay specifically measures antibodies in the blood that can block infection by SARS-Co-V-2, the virus that causes COVID19. One of the key ways the immune system fights a SARS-CoV-2 infection is to make a huge number of antibodies that recognize and bind to the surface of the virus in many different ways and at many different sites. Only a small subset of those antibodies — called neutralizing antibodies — can actually prevent the virus from infecting new cells.

The IMMUNO-COV test uses an innocuous virus that mimics SARS-CoV-2 and detects neutralizing antibodies in the blood that can recognize and stop the virus from infecting new cells. Neutralizing antibodies are detectable in the blood typically 14 days after the onset of infection and their levels vary widely from person to person.

Imanis Life Sciences, under a commercial arrangement with Vyriad, is performing the IMMUNOCOV assay in its CLIA-certified laboratory. Mayo Clinic has licensed IMMUNO-COV for evaluating donors in the national COVID-19 convalescing plasma study. Applications for the IMMUNO-COV assay include:

  • Assessing neutralizing antibody levels in potential donors of COVID-19 convalescent plasma for treatment of patients infected with SARS-CoV-2 (plasma with high neutralizing antibody titers is preferred).
  • Evaluating the relative effectiveness of SARS-COV-2 vaccine candidates in clinical trials.
  •  Testing healthcare workers and other at-risk professionals with prior SARS-CoV-2 infections to assess the strength and durability of their immunity to COVID-19 over time.

Rianna Vandergaast, Ph.D., the lead IMMUNO-COV scientist at Imanis Life Sciences, will give both presentations at the ASGCT COVID-19 Symposium.

12:00pm-1:00pm central time, Tuesday, September 15 IMMUNO-COV: An Antibody Test for COVID-19-Neutralizing Antibodies

This luncheon presentation will provide technical information about the assay and focus on its significance, potential applications and ongoing assay research and improvements.

3:48pm-4:00pm central time, Wednesday, September 16 Development and Validation of a High-Throughput Clinical Assay for Detecting SARS-CoV-2-Neutralizing Antibodies.

This is 10-minute technical overview of the development and validation of IMMUNO-COV, as well as further assay development

To attend the free virtual conference, register here.

[https://www.webcastregister.live/asgct_covid19_symposium/register.php]

A recording of Dr. Vandergaast’s presentations will be available on the ASGCT website for 30 days following the symposium.

IMMUNO-COV is a product of Vyriad, Inc., developed in collaboration with its affiliate Imanis Life Sciences, Regeneron and Mayo Clinic.

About Imanis Life Sciences

Imanis Life Sciences is a leading provider of products and services to accelerate development of viro-immuno-oncology drugs. Our mission is to advance pharmacokinetics and imaging, promote widespread adoption of noninvasive in vivo imaging in preclinical and clinical research. Our team of dedicated and passionate scientists (PhD, MSc, BSc) works closely with clients to facilitate their research, from study design, custom products, and consultation. . For more information, visit www.imanislife.com.

About Vyriad, Inc.

Vyriad is a clinical-stage company developing virus-based therapeutics, focusing initially on proprietary oncolytic virus therapies for the treatment of cancers with significant unmet needs. Founded by scientists at Mayo Clinic and the University of Miami, Vyriad programs viruses to selectively attack cancer cells, thereby igniting antitumor immune responses that can complete the process of tumor destruction and prevent disease recurrence. Our lead platforms, derived from either vesicular stomatitis virus or measles virus (VSV), are being evaluated in ongoing Phase 2 clinical trials addressing multiple cancer types. Vyriad and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have entered into a broad strategic agreement for the discovery and development of new oncolytic virus treatments for cancer leveraging Vyriad’s VSV platform and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) as well as its unmatched antibody discovery capabilities. Vyriad is a privately held company based in Rochester, Minnesota.

Contacts:

Media
David Walsh
dwalsh@vyriad.com
651.503.8248

Company inquiries
Michael Herbert
Herbert.michael@imanislife.com
612.309.7801

STAR TRIBUNE AUGUST 28 2020

BY GAIL ROSENBLUM

Six months now into this perplexing and powerful pandemic, we’ve grown accustomed to seeing our “front line” heroes whenever we venture out and also when we don’t. We see them, masked of course, behind plexiglass at the grocery store, dropping packages at our door, overheating in head-to-toe PPE to reach into our cars to test us for COVID-19. We continue to thank them for their invaluable and brave service. This month, though, we are pleased to bring you a different kind of “front line” hero. They are doctors, scientists, researchers — even a COVID-19 survivor — working largely behind the scenes in labs to track the virus, dig into data, study the efficacy of drugs and antibody tests, all with a common goal: To crack the code on COVID as quickly as possible and get our state and nation back on track. And while it’s un-Minnesotan to say this, we can and should be proud that so many national leaders reside right here in our state.

RIANNA VANDERGAAST
Senior Scientist, Imanis Life Science, LLC

The body makes antibodies to fight COVID-19 but many of those tiny proteins don’t actually block the coronavirus from infecting a cell. Only “neutralizing antibodies” protect against infection. So Rianna Vandergaast spent much of her spring holed up in labs in Rochester, designing and running experiments on ways to detect neutralizing antibodies. In June, Mayo Clinic announced it would begin offering the first-of-its-kind test that Vandergaast and her colleagues at Imanis Life Sciences and sister company Vyriad designed to detect these difficult-to-spot proteins. The test will be used to see whether people can become infected with COVID-19 more than once, whether plasma from COVID patients can fight infection in others and how well vaccine candidates perform. In other words, she said, “Are those antibodies able to neutralize future virus?” JOE CARLSON

Mayo Clinic to Offer Vyriad Neutralizing Antibody Test

Mayo Clinic has licensed the Vyriad IMMUNO-COV™ antibody test that detects and quantifies neutralizing antibodies, the critical subset of antibodies known to protect against SARS-CoV-2 viral infections. IMMUNO-COV is distinct from most existing serology tests which do not confirm the virus-neutralizing function of antibodies they detect.

Mayo Clinic plans to use a slightly modified version of assay to support the nationwide convalescent plasma exchange study and other COVID-19 research efforts. The test will be available through Mayo Clinic Laboratories in late June.

“We are delighted that Mayo Clinic is moving forward with the test, which will expand the availability of this important new addition to the serology testing landscape,” said Stephen Russell, MD, PhD, Vyriad President and Chief Executive Officer.

Vyriad launched IMMUNO-COV last month and is conducting the test at its CLIA-certified laboratory in Rochester, Minn.  Healthcare providers and laboratories may order the test and submit blood samples for analysis to Vyriad. For more information, contact IMMUNO-COV@vyriad.com.

Vyriad and Imanis Life Sciences developed IMMUNO-COV in collaboration with Regeneron and the Mayo Clinic

Scientific Paper Available on Development and Validation of IMMUNO-COV™, Vyriad’s SARS-CoV-2 Virus-Neutralizing Antibody Test

Vyriad and Imanis Life Sciences announced today the publication of a scientific paper on the development and validation of IMMUNO-COV™, a high-throughput clinical test to quantitatively measure SARS-CoV-2-neutralizing antibodies, the specific subset of anti-SARS-CoV-2 antibodies that block viral infection. The paper is available on bioRxiv, a free online archive and distribution service for non-peer-reviewed manuscripts in the life sciences.

The paper is titled, “Development and validation of IMMUNO-COV™: a high-throughput clinical assay for detecting antibodies that neutralize SARS-CoV-2.” bioRxiv accepts non-peer-reviewed articles to facilitate the rapid sharing of new scientific information about COVID-19 and other life sciences areas of research.

The disease-causing SARS-CoV-2 virus uses its spike protein to infect healthy cells and spread throughout the body. The IMMUNO-COV antibody test uses an innocuous virus that has been engineered to carry this SARS-CoV-2 spike glycoprotein on its surface. It analyzes human blood serum to detect only the antibodies capable of ‘blocking’ the action of this spike glycoprotein, thus preventing the SARS-CoV-2 virus from infecting new cells. This is distinct from most existing serology tests which do not confirm the virus-neutralizing function of antibodies they detect. News release.

Vyriad and Imanis Life Sciences developed the assay in collaboration with Regeneron and the Mayo Clinic.

Vyriad Inc. Announces Development of a New Antibody Test to Determine Protective Immunity From COVID-19

Vyriad test detects SARS-CoV-2 virus-neutralizing antibodies

Developed as part of an ongoing collaboration with Regeneron

ROCHESTER, Minn., May 12, 2020 – Vyriad, Inc. announced today that it has completed the development of a serology test to measure protective immunity against SARS-CoV-2, the novel coronavirus that causes COVID-19. The Vyriad IMMUNO-COV™ antibody test detects neutralizing antibodies, the critical subset of antibodies known to protect against SARS-CoV-2 viral infections. The ability to reliably identify these neutralizing antibodies will be critical to the safe re-opening of work, school and social settings. Vyriad and Regeneron jointly developed the test as part of their existing discovery and development collaboration. The test is expected to be available through major CLIA-certified testing labs by the end of May.

The disease-causing SARS-CoV-2 virus uses its spike protein to infect healthy cells and spread throughout the body. The IMMUNO-COV™ antibody test uses an innocuous virus that has been engineered to carry this SARS-CoV-2 spike glycoprotein on its surface. It analyzes human blood serum to detect only the antibodies capable of ‘blocking’ the action of this spike glycoprotein, thus preventing the SARS-CoV-2 virus from infecting new cells. This is distinct from most existing serology tests which do not confirm the virus-neutralizing function of antibodies they detect.

“We believe the ability of our test to accurately identify virus-neutralizing antibodies provides a higher degree of certainty about whether individuals have acquired protective immunity from COVID-19, including in those people who have never had symptoms of COVID-19,” said Stephen Russell, M.D., Ph.D., Chief Executive Officer of Vyriad, a clinical-stage biotechnology company specializing in virus therapies to treat diseases, including cancer. “We believe this is the first commercially scalable test of its kind and could become the gold standard for determining protective immunity, because it detects specifically the antibodies capable of blocking re-infection. Our hope is that this assay will be used to help inform back-to-work decisions for individuals who believe they have been exposed to the virus.”

Since the start of the COVID-19 outbreak in December 2019, experts believe millions of people around the world may have contracted the disease, many with asymptomatic infections or mild infections that go undetected or undiagnosed. People who recover from COVID-19 infection may develop an antibody response to the pathogen, which creates immunological memory and potentially protects them from future exposure to the virus. These antibodies are typically detectable in the blood approximately 14 days after the onset of infection.

“Regeneron is working on multiple fronts to find effective approaches against SARS-CoV-2, including the development of a novel antibody therapeutic that could be used as prevention or treatment for the disease,” said Christos Kyratsous, Ph.D., Vice President of Research, Infectious Diseases and Viral Vector Technology at Regeneron. “We’re encouraged to also be working with our collaborator Vyriad to utilize both companies’ virus engineering capabilities in order to deploy a much-needed testing approach.”

Vyriad has internally validated this assay and is conducting ongoing assay verification studies to continually evaluate assay performance. The assay validation results and methodology have been submitted to the FDA in accordance with regulatory requirements for COVID-19 Emergency Use Authorization.

The test is currently run at Vyriad’s CLIA-approved laboratory in Rochester, Minnesota. Vyriad does not engage in patient services and can only accept testing requests from a referring physician or laboratory at this time.  It is anticipated that this test will be commercially available through major laboratories within the next few weeks.

Since October 2019, Vyriad has been working exclusively with Regeneron to research and develop vesicular stomatitis virus (VSV)-based oncolytic virus technologies. This collaboration now includes the IMMUNO-COV™ antibody test, which was developed utilizing the deep scientific expertise of both companies. Regeneron’s proprietary VelociSuite® technologies and Vyriad’s virus engineering capabilities enabled development of this scalable assay in a rapid timeframe.

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