Oct. 29, 2020 11:00 UTC

Agency-wide CRADA agreement also includes studies with Brain-Chip in Alzheimers disease, Intestine-Chip in microbiome health, and Liver-Chip in individualized toxicity responses

BOSTON--(BUSINESS WIRE)-- Emulate, Inc.. announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Food and Drug Administration (FDA) to enable multiple studies across FDA offices in priority research areas, including programs to evaluate COVID-19 vaccines and understand human immune response against SARS-CoV-2, the virus that causes COVID-19.

Under the CRADA, the FDA will use a range of Organ-Chips from Emulate to study the safety, efficacy, and mechanisms of drugs regulated by the FDA. The initial studies use Organ-Chipswhich are able to recreate the natural physiology of specific human tissues and organsin areas where conventional cell culture and animal-based testing methods have limitations in reflecting human biology and disease mechanisms that are not yet understood, such as Alzheimers disease and COVID-19. This new CRADA agreement follows the successful completion of the first Emulate CRADA with the FDA initiated in 2017 that focused on toxicity studies using the Liver-Chip.

We are excited to continue our relationship and collaborative work with the FDA, combining Emulates expertise with leading researchers at the FDA to explore how our Organ-Chips can lead to new ways to improve standards, understand disease and drug mechanisms, and better evaluate the safety and efficacy of products for human use, said Jim Corbett, Chief Executive Officer of Emulate. The FDA is a valued stakeholder and strategic collaborator as our Human Emulation System continues to be adopted for the evaluation of pharmaceuticals and other products that are reviewed and approved by regulatory authorities to protect and improve human health.

The FDA has a long history of supporting efforts to develop new regulatory tools that have the potential to refine, reduce, or replace animal testing, said FDA Chief Scientist, Rear Admiral Denise Hinton. Our deep engagement in research collaborations like this one is crucial to advancing technologies like Organ-Chips that may help identify toxicity, efficacy, and disease susceptibility earlier in product development. A robust commitment to science is at the core of our public health mission and helping to facilitate advancements in regulatory science reflects our dedication to fostering the development of critical medical products to address public health threats like COVID-19.

COVID-19 Lung-Chip study to advance understanding of protective immunity and vaccine safety

The Lung-Chip study, which will be led by the FDAs Center for Biologics Evaluation and Research (CBER), aims to address one of the most important questions regarding protective immunity against SARSCoV-2: why individuals experience a wide spectrum of disease severity and what constitutes a real protection against future infection. The Emulate human Lung-Chip offers the unique functionality of mechanical strain and dynamic fluid flow to recreate the microenvironment found in the human lung. Highlights of the study objectives include:

We are enthusiastic to collaborate with essential regulatory partners like the FDA to apply our unique Organ-on-Chips platform to advance the understanding of the SARS-CoV-2 virus and to do our part in bringing safe and effective COVID-19 vaccines and treatments to the world, Lorna Ewart, PhD, Executive Vice President, Scientific Liaison of Emulate. There is a time-sensitive need to contribute our technology and expertise to support the FDA with their COVID-19 response, and over time, there will continue to be a need to understand longer-term protective immunity and vaccine safety.

Studies with multiple Organ-Chips support areas of emerging disease biology and drug mechanisms

The CRADA is led by the FDAs Office of the Chief Scientist, allowing for studies across FDA offices with Organ-Chips from Emulate. Through the CRADA, multiple installations of the Human Emulation System will be established in several FDA laboratories.

In addition to the COVID-19 study, other projects that will be initiated under the CRADA include:

More information about how Emulate is enabling COVID-19 research can be found in the companys latest blog post.

About Emulate, Inc.

Emulate Inc. is a privately held company that creates living products for understanding how diseases, medicines, chemicals, and foods affect human health. Our lab-ready Human Emulation System includes three components: Zo Culture Module, Organ-Chips, and analytical software applications. The platform provides a window into the inner workings of human biology and diseaseoffering researchers a new technology designed to predict human response with greater precision and detail than conventional cell culture or animal-based experimental testing. Each of Emulates proprietary Organ-Chipsincluding the liver, intestine, and kidneycontains tiny hollow channels lined with tens of thousands of living human cells and tissues and is approximately the size of an AA battery. An Organ-Chip is a living, microengineered environment that recreates the natural physiology and mechanical forces that cells experience within the human body. Our founding team pioneered the Organs-on-Chips technology at the Wyss Institute for Biologically Inspired Engineering at Harvard University. Emulate holds the worldwide exclusive license from Harvard University to a robust and broad intellectual property portfolio for the Organs-on-Chips technology and related systems. For more information, please visit http://www.emulatebio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201029005207/en/

Read more here:
Emulate Signs Collaborative Agreement with the FDA to Apply Lung-Chip to Evaluate Safety of COVID-19 Vaccines and Protective Immunity Against...