Virax Biolabs and Emory University: A New Era in Immunology Research

Virax Biolabs Partners with Emory University on Groundbreaking Studies

Virax Biolabs Group Limited (NASDAQ: VRAX), an innovative biotechnology company specializing in immune response detection and diagnostics, has entered into a significant partnership with Emory University. This agreement will facilitate advanced clinical studies focused on understanding immune responses in individuals affected by post-viral syndromes, particularly targeting the effects of post-acute sequelae of SARS-CoV-2, commonly known as long COVID.

Details of the Research Services Agreement

The collaboration is formalized through a Research Services Agreement with the Center for the Advancement of Diagnostics for a Just Society, often referred to as the ADJUST Center. Under this agreement, the Emory Laboratory for Innovative Assay Development (ELIAD) will spearhead key efforts such as patient recruitment, testing, and detailed data analysis. This clinical data will be instrumental in supporting Virax's regulatory submissions and future commercial endeavors.

Preparing for FDA Feedback

This partnership coincides with Virax's strategic planning for a pre-submission meeting with the U.S. Food and Drug Administration (FDA). Scheduled for early September, this meeting aims to gather the FDA's insights regarding the proposed uses and regulatory pathways for ViraxImmune™ in managing long COVID. The feedback will significantly influence the design of the pivotal U.S. clinical trial and guide the company's subsequent regulatory and commercialization strategies.

CEO Insights on the Collaboration

James Foster, the Chief Executive Officer of Virax Biolabs, remarked on the importance of collaborating with Emory University, a leading institution recognized for its immunology and clinical research. Foster highlighted that, given the millions of individuals suffering from long COVID and related syndromes without effective diagnostic solutions, ViraxImmune™ stands poised to address pressing medical needs. This collaboration not only aims to bolster their entry into the U.S. market but also seeks to create lasting value for shareholders by positioning Virax as a frontrunner in immune profiling diagnostics.

Expert Commentary from Emory University

Dr. Wilbur A. Lam, MD, PhD, who is a professor at Emory University and a director at the ADJUST Center, emphasized the critical need for better understanding and diagnosis of post-viral syndromes like PASC. He stated that immune profiling technologies have the potential to yield essential insights into immune functions, thereby enabling more accurate diagnostics and informing treatment procedures for patients.

What is ViraxImmune™?

ViraxImmune™ is an advanced T cell testing technology designed to assess a patient's immune response profile. Unlike traditional antibody tests which merely measure the presence of antibodies, this innovative approach evaluates T cell reactivity to paint a more complete picture of immune health, especially in patients experiencing chronic and post-viral conditions.

About Virax Biolabs Group Limited

Virax Biolabs Group Limited is dedicated to facilitating the detection and understanding of immune responses to viral diseases. The company is advancing T cell-based testing technologies with a goal of developing a comprehensive immunology profiling platform. Their innovative testing methods hold promise for aiding in the diagnosis and treatment of post-viral disorders, including long COVID and other chronic conditions linked to immune system dysregulation.

About Emory University

Emory University is a globally recognized research institution based in Atlanta, celebrated for its impactful contributions to medical innovation, healthcare, and scientific research. Renowned for its School of Medicine and a comprehensive healthcare network, Emory excels in translational research, particularly in the fields of infectious diseases, immunology, and clinical trials.

Frequently Asked Questions

1. What is the main focus of the partnership between Virax Biolabs and Emory University?

The partnership primarily focuses on conducting clinical studies of ViraxImmune™ to evaluate immune responses in individuals suffering from post-viral syndromes, especially long COVID.

2. What will Emory University's role be in this collaboration?

Emory University, through its ADJUST Center, will assist in patient recruitment, testing, and data analysis for the clinical studies, generating essential insights to support regulatory submissions.

3. When is the FDA meeting scheduled, and why is it significant?

The FDA pre-submission meeting is planned for early September and is crucial for obtaining the FDA's feedback on the regulatory pathway and trial design for ViraxImmune™.

4. How does ViraxImmune™ differ from traditional immunology tests?

Unlike standard antibody tests, ViraxImmune™ assesses T cell reactivity, providing a more comprehensive evaluation of immune health, particularly in chronic and post-viral conditions.

5. What long-term goals does Virax Biolabs aim to achieve through this study?

Virax Biolabs seeks to establish itself as a leader in immune profiling diagnostics and address critical diagnostic gaps in post-viral syndrome care, generating significant long-term value for shareholders.

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