WuXi Biologics, a leading global contract research, development, and manufacturing organization, has announced a strategic collaboration with Virogen Biotechnology Inc. to advance VG712, a groundbreaking first-in-class anti-CD3 immunotoxin, toward commercial manufacturing. The partnership positions both companies to address significant unmet medical needs through innovative immunotherapy approaches.
Novel Immunological Reset Therapy
VG712 represents a revolutionary therapeutic strategy known as immunological reset, designed to restore immune function through rapid depletion of the patient's existing T cell pool. By targeting T cell dysregulation, which lies at the core of cancers, autoimmune diseases, and other conditions, this approach allows the immune system to regenerate from a clean slate and regain its innate ability to control disease.
The therapy offers new hope for sustained remission and, in some cases, a clinical cure for patients with conditions characterized by immune dysfunction. VG712 has received Fast Track designation from the US Food and Drug Administration (FDA), recognizing its potential to address serious unmet medical needs.
Comprehensive Manufacturing Partnership
Under the agreement, WuXi Biologics will provide comprehensive services including technology transfer, process validation, and commercial manufacturing of both drug substance and drug product for VG712. The partnership leverages WuXi Biologics' end-to-end microbial fermentation platform, industry-leading manufacturing capabilities, and world-class quality systems.
"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," stated Dr. Chris Chen, CEO of WuXi Biologics.
Clinical Development and Regulatory Timeline
A pivotal Phase II trial for VG712 is currently underway, with a Biologics License Application (BLA) submission targeted between 2027 and 2028. The accelerated timeline reflects the therapy's Fast Track designation and the strategic manufacturing partnership's ability to streamline the path from late-stage development to commercial-scale production.
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."
Expanded Manufacturing Infrastructure
The partnership coincides with WuXi Biologics' construction of a new microbial manufacturing site in Chengdu, China, spanning 95,000 square meters. The facility will be equipped with a 15,000 L fermenter, enabling annual production of 80 to 110 batches of drug substance, with potential expansion capacity up to 60,000 L.
The Chengdu site will house China's first dual-chamber lyophilization production line alongside a vial filling line, with overall drug product manufacturing capacity exceeding 10 million vials annually. This infrastructure expansion marks a significant enhancement of WuXi Biologics' global network, enabling more agile, efficient, and scalable solutions for partners.
Dr. Chen emphasized the strategic importance of the facility expansion: "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."
