"WuXi Biologics, a leading global contract research, development, and manufacturing organization, announced a strategic collaboration with Virogen Biotechnology Inc. (Virogen). Under the agreement, WuXi Biologics will provide comprehensive services, including technology transfer, process validation, and commercial manufacturing of both drug substance (DS) and drug product (DP) for VG712, Virogen’s lead clinical-stage asset. The partnership is expected to accelerate VG712’s path to global market approval.
• VG712 is a first-in-class anti-CD3 immunotoxin designed to restore immune function through rapid depletion of the patient’s existing T cell pool—a novel therapeutic strategy known as immunological reset.
• By targeting T cell dysregulation, which lies at the core of cancers, autoimmune diseases, and other conditions, this groundbreaking approach allows the immune system to regenerate from a clean slate and regain its innate ability to control disease, offering the new hope for sustained remission and, in some cases, a clinical cure.
• Leveraging its end-to-end microbial fermentation platform, industry-leading DS and DP manufacturing capabilities, and world-class quality systems, WuXi Biologics will enable Virogen to advance VG712 from late-stage development to commercial-scale production.
• VG712 has received Fast Track designation from the US Food and Drug Administration (FDA), and a pivotal Phase II trial is currently underway.
• A Biologics License Application (BLA) submission is targeted between 2027 and 2028, aiming to address significant unmet medical needs.
Dr. Chris Chen, CEO of WuXi Biologics, stated: “We are delighted to partner with Virogen on this groundbreaking therapy which further demonstrates our capabilities in enabling the research, development, and manufacturing of complex molecules through our integrated microbial fermentation platform. The construction of our Chengdu microbial manufacturing site marks a significant expansion of our global network, allowing us to deliver more agile, efficient, and scalable solutions to our partners. In addition, we can bring more strategic resources to Virogen throughout its development journey. Together, we aspire to drive new breakthroughs in immunotherapy and bring renewed hope to patients worldwide.”
Su Chen, founder of Virogen, commented: “This collaboration marks a major milestone for Virogen. WuXi Biologics’ strong track record in translating innovative science into commercial therapies makes it an ideal partner as we prepare for VG712’s global launch. We remain committed to delivering transformative treatments in immunotherapy that can truly save lives.”
WuXi Biologics is a leading global contract research, development and manufacturing organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
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