WuXi Biologics to Manufacture Virogen’s FDA Fast-Tracked VG712 Immunotoxin

• WuXi Biologics will provide technology transfer, validation, and commercial manufacturing for VG712, a first-in-class immunotoxin developed by Virogen.

• The therapy, currently in Phase II and FDA Fast Tracked, targets immune reset through T cell depletion and aims for BLA submission between 2027–2028.

WuXi Biologics, a global Contract Research, Development, and Manufacturing Organization (CRDMO), has announced a strategic collaboration with Virogen Biotechnology Inc. to advance the development and commercial production of VG712, a novel immunotherapy currently in a pivotal Phase II trial.

Under the agreement, WuXi Biologics will deliver comprehensive contract manufacturing services, including technology transfer, process validation, and commercial-scale production of both drug substance and drug product. The collaboration leverages WuXi Biologics’ microbial fermentation platform and global manufacturing network, including its newly constructed site in Chengdu.

VG712 is a first-in-class anti-CD3 immunotoxin designed to restore immune function by depleting the patient’s T cell population, enabling a complete immunological reset. The therapy targets T cell dysregulation, a hallmark of cancers and autoimmune diseases. With Fast Track designation from the U.S. Food and Drug Administration, VG712 is expected to reach Biologics License Application (BLA) submission between 2027 and 2028.

Dr Chris Chen, CEO of WuXi Biologics, said: “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.”

Su Chen, Founder of Virogen, added, “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.”