IN THE NEWS

CLICK ON DATE FOR NEWS

Imanis Life Sciences Announces Improvements and Increased Capacity of IMMUNO-COVTM, a First-in-Class Neutralizing Antibody Test for COVID-19 

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

ROCHESTER, Minn., Nov. 19, 2020 – Imanis Life Sciences, LLC (“Imanis” or “The Company”) announced today that it has completed validation of its latest improved IMMUNO-COVTM assay, the first scalable, quantitative virus neutralizing antibody test for COVID-19. This validation adds plasma as an accepted sample type, and improves sensitivity, stability and reliability while maintaining high accuracy. The Company also announced that it has been processing samples from its research partners and has completed steps necessary to increase test processing capacity in its CLIA-accredited facility in Rochester, Minn.

“IMMUNO-COV’s performance has been outstanding over a large validation group and across a variety of customer samples,” said Michael Herbert, Chief Commercial Officer at Imanis. “With increased lab capacity and enough manufactured virus on-hand to run over five million tests, we anticipate strong interest in the assay and are ready to expand availability across all areas of critical need.”

Imanis has been processing tests for research partners for several weeks. At this time, its lab is equipped to address large scale testing requirements for:

  • 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.
  • Physician ordered tests where indicated for patients presumed or suspected to have been exposed to the virus (or a vaccine) more than 2 weeks prior to testing.

IMMUNO-COV detects and quantifies virus neutralizing antibodies, which can prevent the spread of SARS-CoV-2 in the body, the virus that causes COVID-19. Neutralizing antibodies become detectable in the blood approximately 14 days after the onset of infection. IMMUNO-COV was jointly developed by affiliates Imanis and Vyriad, Inc., in collaboration with Regeneron and Mayo Clinic.

About Imanis Life Sciences

Imanis Life Sciences is a leading provider of laboratory assays and research services that can accelerate the development of a broad range of virus-based gene therapies and immuno-oncology drugs. Our mission is to strengthen the pharmacological underpinnings of virus-based therapeutics and to promote the adoption of noninvasive in vivo reporter gene imaging in preclinical and clinical research.  Our team of dedicated and passionate scientists (PhD, MSc, BSc) works closely with clients to facilitate their preclinical or clinical-stage virus-based research and development programs. For more information, visit https://imanis-immunocov.com/.

 

Media Contact

Will Johnson

Antenna Group

imanis@antennagroup.com

(201) 465-8019

 

Company Inquiries

Michael Herbert

Chief Commercial Officer

Imanis Life Sciences

Herbert.michael@imanislife.com

(612) 309-7801

Study suggests herd immunity to COVID-19 in New York City is low

By Sally Robertson, B.Sc.

November 9, 2020

Researchers in the United States have estimated that the proportion of people in New York City who developed antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the first wave of the coronavirus disease 2019 (COVID-19) pandemic is around one in eight.

Larry Luchsinger from New York Blood Center (NYBC) and colleagues from Regeneron Genetics Center, Imanis Life Sciences, and Regeneron Pharmaceuticals, Inc. say their findings suggest that background or “herd immunity” continues to be low and that eight months into the US pandemic, it is likely that the proportion of susceptible individuals remains very high, possibly greater than 80%.

The team says the study also suggests that the presence of antibody-based immunity is not necessarily associated with the development of neutralizing antibodies against SARS-CoV-2.

The researchers say the strategy they used to estimate seroprevalence in this study could be leveraged for future rapid assessment of seroprevalence/seroconversion in this cohort to help guide public health decision making.

A pre-print version of the paper is available on the server medRxiv*, while the article undergoes peer review.

Blood Donor Demographics of NYC Metro Area A; Choropleth of donation site locations used for the collection of blood donor samples. Heatmap (gradient bar, top) indicates the frequency of donors collected per site. B; Distribution of NYC Metro area donor age (red bars) compared to NYC demographics (blue bars). Dotted lines represent the best fit to a Gaussian distribution and r2 value represents calculated goodness of fit to distribution plot. C; Gender frequency of NYC Metro area donors (red bars) compared to NYC demographics (blue bars). Chi-square test for goodness of fit to observed (donors) versus expected (NYC demographics) results; * p<0.01 D; Ethnicity frequency of NYC Metro area donors (red bars) compared to NYC demographics (blue bars). Chi-square test for goodness of fit to observed (donors) versus expected (NYC demographics) results; * p<0.01

 

Serological tests of could be valuable for guiding public health policies

Since the first cases of SARS-CoV-2 were identified in Wuhan, China late December 2019, transmission models have suggested that recovery following infection may provide antibody-mediated immunity against future infection.

Serological tests that can identify individuals who have acquired antibodies against the virus (seroconversion) and the frequency of this seroconversion (seroprevalence) in a population could be valuable for guiding the development of public health policies.

As the infection number continues to rise and vaccine programs are introduced, serologic testing will be crucial for monitoring the development of herd immunity – the point where enough people have become immune, and person-to-person transmission is no longer likely.

However, the tests used for population-wide serological assessment must be reliable, credible, reproducible and high-throughput, say Luchsinger and team.

Furthermore, it is vital to understand the degree of correlation of any given assay’s “reactivity” with the presence of neutralizing antibodies, say the researchers, since only a subset of virus-specific antibodies exhibit neutralizing activity.

“Thus, studies that evaluate serological test designs are necessary to associate a serological result with a probability of immunity,” writes the team. “These data, then, can be used to assist public health officials in modeling projections and in informing policy-making  decisions, including the safe ‘reopening’ of cities, states, and regions.”

A range of SARS-CoV-2 antibody assays are currently available, but differences in test characteristics, particularly sensitivity, could lead to variability and potential bias when estimating immunity levels among different locales or subpopulations.

However, two platforms that have been widely cited are in-house enzyme-linked immunosorbent assays (ELISA) and high-throughput serological assays (HTSA), say Luchsinger and team.

 

What did the current study involve?

New York City (NYC) was one of the first epicenters of the COVID-19 pandemic and had the highest case count per capita in the United States.

“Seroconversion, therefore, is likely to be substantial in a random sampling of NYC residents,” say the researchers.

The team conducted a point-in-time 1,000-person cohort study involving serial blood donors (aged a median of 48 years) in the NYC metropolitan area.

Plasma samples randomly collected from NYBC blood donation centers between June and July 2020 were tested using multiple commercially available assays, including ELISAs and HTSAs.

These were then tested and associated with assays for neutralizing antibodies.

 

What did the study find?

Among the 1,000 blood donor samples collected, the estimated seroprevalence rate using a test called the Ortho Clinical Diagnostics VITROS 120 Total Ig Test (Ortho) HTSA assay indicated a seroprevalence of 12.1%.

Another test called the Abbott Labs Architect SARS-CoV-2 IgG (Abbott) HTSA assay indicated that the seroprevalence was 10.9%.

The researchers also found that ELISA assays, which are the current gold-standard of serological quantification, corresponded with donor seropositivity as detected by these HTSAs, thereby validating the use of ELISAs in this context.

Importantly, the assays showed that the nature of the antibody-mediated immunity was not invariably associated with the development of neutralizing antibodies. Neutralizing activity against SARS-CoV-2 was wide-ranging and skewed towards slow-to-moderate titers of neutralizing antibodies.

The team says the data suggest that the seroconversion rate was around 1 in 8 among the blood donors since the pandemic began in NYC and that this estimate is in agreement with other reports from state and local departments of health.

 

What are the implications of the findings?

“Our findings demonstrate a comparable seroprevalence estimate can be discerned using a widely accessible blood donor population and it [is] an important metric during this catastrophic outbreak,” write the researchers.

This strategy can therefore be leveraged in its design for future studies to implement rapid seroconversion/seroprevalence monitoring, they say.

Furthermore, “these conclusions suggest that in the absence of a vaccine, “background” or “herd” immunity continues to be low at four months post commencement, and, now eight months into the US pandemic, it is probable that the susceptible population remains very high, and possibly at ~80% or greater,” the team warns.

 

*Important Notice

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

                                                                                                                                                           

Journal reference:

 

Published: https://www.news-medical.net/news/20201109/Study-suggests-herd-immunity-to-COVID-19-in-New-York-City-is-low.aspx

INTERVIEW

Transforming the treatment of cancer with oncolytic viruses

Guest: Stephen J. Russell, CEO, Vyriad
In this episode of Conversations in Healthcare, Mike Ward, Global Head of Thought Leadership at DRG, speaks with Stephen Russell, CEO of Vyriad. Dr. Russell reveals invaluable insights for those looking for or currently putting together partnership deals. Stephen shares his journey from academia at the Mayo Clinic to founding Vyriad, and eventually partnering with Regeneron for the development of new oncolytic virus treatments for cancer. Learn how Vyriad pivoted their technology to develop antibody tests for COVID-19 during the crisis.

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.

LET'S KEEP IN TOUCH

©2020 Imanis Life Sciences. All rights reserved.

Log in with your credentials

Forgot your details?