Mabion Releases First Batch of NovalGen’s T-Cell Engager NVG-222 for Human Trials

• Mabion has released the first clinical batch of NovalGen’s T-cell engager NVG-222 for use in upcoming human trials.

Mabion, a European biologics CDMO, has released the first batch of NovalGen’s NVG-222, a next-generation T-cell engager, ahead of its first-in-human clinical trials scheduled for the second half of 2025. The release marks a new phase in the strategic partnership between the two companies, initially disclosed in August 2024.

The contract manufacturing agreement supports the development of NVG-222, a bispecific T-cell engager that targets ROR1 and CD3, intended to treat blood cancers and solid tumours. NovalGen’s proprietary AutoRegulation (AR) technology is a key feature of the therapy, aiming to improve safety and expand therapeutic applications.

Under the collaboration, Mabion completed the transfer of the manufacturing process and analytics package. A quality audit confirmed compliance and operational readiness, with the programme positioned as a foundation for future joint development.

“The successful transfer of the manufacturing process and product analytics package, confirmed by the production of the drug for clinical trials and its release, are clear evidence of Mabion’s operational excellence,” said Julita Balcerek, Ph.D., Chief Operating Officer of Mabion. “These achievements are a direct result of Mabion’s transformation into a CDMO.”

NovalGen CEO and Founder Professor Amit Nathwani described the collaboration as “characterised by exceptional technical execution, a shared commitment to quality, and a mutual drive to deliver innovative therapies.” The companies plan to expand the partnership as NovalGen progresses its pipeline in oncology and autoimmune indications.