Biologics CDMO Mabion has entered into a development and manufacturing partnership with UK-based NovalGen.
The new collaboration means that Mabion will be responsible for the progression of NovalGen's T-cell engager candidate, NVG-222, into Phase I clinical trials.
Through this deal, Mabion will be responsible for the manufacture of NVG-222 for clinical trials, which are scheduled to begin in the second half of 2025.
NVG-222 is a ROR1 and CD3-targeting T-cell engager that may be suitable for the treatment of both blood cancers and solid tumours.
Harnessing NovalGen's proprietary AutoRegulation technology, the therapeutic is designed to be more efficacious and less toxic, while having a wider therapeutic index compared with other T-cell engagers in development.
"By securing this manufacturing deal with Mabion, we progress on our journey to bring safer, more effective immunotherapies to patients," noted NovalGen's Founder and CEO, Amit Nathwani.
"As we prepare for clinical trial initiation in the second half of 2025 and continue progressing our pipeline — especially in oncology and autoimmune indications — we look forward to expanding our partnership with Mabion," he added.
“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," stated Mabion's Chief Operating Officer, Julita Balcerek.
The achievements of this collaboration, according to Balcerek, were the result of Mabion's transformation into a CDMO, which began in 2023.
"Not only have we expanded our manufacturing capabilities and technology portfolio, but we have also strengthened our business development and internal processes, enabling us to operate as a world-class CDMO and meet the needs of global customers," she concluded.
