Poland-based CDMO Mabion has completed the first GMP-compliant batch of NVG-222, a next-generation T-cell engager developed by UK biotech NovalGen, ahead of planned first-in-human trials in late 2025.

NVG-222 is a bispecific antibody targeting CD3 and ROR1, designed for use in both hematologic cancers and solid tumours. It is the first candidate to use NovalGen’s proprietary AutoRegulation (AR) technology, aimed at improving the therapeutic index of T-cell engagers by reducing toxicity without compromising efficacy.

The milestone follows a successful technology transfer and development programme under Mabion’s growing CDMO offering. The partnership, originally disclosed in August 2024, reflects both companies’ commitment to accelerating development of safer and more effective immunotherapies.

“This is clear evidence of our operational maturity and our transformation into a world-class CDMO,” said Julita Balcerek, chief operating officer at Mabion. “Our strengthened manufacturing capabilities, tech portfolio, and internal processes are now enabling us to support global clients in bringing cutting-edge therapies to clinic.”

NovalGen CEO professor Amit Nathwani said the collaboration had been marked by “exceptional technical execution and a shared drive to deliver truly impactful therapies.” He added that NVG-222 represents a major milestone in the company’s plans to advance a pipeline of oncology and autoimmune candidates.

Mabion has indicated that the NVG-222 programme may serve as a platform for broader collaboration with NovalGen, as both companies explore new applications of the AR platform and next-generation biologic production.