In order to accelerate the global fight against blood cancers and hard-to-treat solid tumors, end- to-end biologics CDMO Mabion has entered a strategic development and manufacturing partnership with London-based NovalGen to bring the proprietary T-cell engager, NVG-222, to market for phase one of in-human clinical trials which are scheduled to begin in the second half of 2025.

NVG-222 is a bispecific T-cell engager targeting ROR1 and CD3 that could be used to treat both blood cancers and solid tumors. It is the first agent to use NovalGen’s proprietary AutoRegulation (AR) technology, designed to mitigate toxicity, improve efficacy and expand the therapeutic index of T-cell engagers. This technology offers the potential for a paradigm shift in immuno-oncology therapies.

With the first batch drug released, this partnership signifies a pivotal moment in the development of next-generation immunotherapies, offering a potential new lifeline for cancer patients. Leveraging Mabion’s progressive manufacturing and development capabilities to minimize risk in pharmaceutical production, the technology transfer, development and clinical compliance provides a platform for future collaboration on NovalGen’s pipeline of disruptive treatments in development, including promising candidates for both oncology and non-oncology indications.

“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. All this is surrounded by a quality system that has been verified by NovalGen in a successful quality audit. These achievements are a direct result of Mabion’s transformation into a CDMO, which we began in 2023, and the ongoing implementation of our 2025-2030 Strategy,” says Julita Balcerek Ph.D, Chief Operating Officer of Mabion S.A.

“The successful manufacture of NVG-222 marks a major milestone in our journey to bring safer, more effective immunotherapies to patients. Our collaboration with Mabion, a trusted CDMO partner, has been characterized by exceptional technical execution, a shared commitment to quality, and a mutual drive to deliver innovative therapies that truly impact patient lives,” adds professor Amit Nathwani, Founder and CEO of NovalGen.