In a significant move to accelerate the global fight against blood cancers and hard-totreat solid tumours, renowned end- to-end biologics CDMO Mabion have entered into a strategic development and manufacturing partnership with London based NovalGen an existing client with whom cooperation under CDMO orders was first disclosed in current report No. 13/2024 dated August 16, 2024. The goal of the partnership is 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.

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 minimise 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. 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” – says Julita Balcerek Ph.D, Chief Operating Officer of Mabion S.A.

NVG-222 is a bispecific T-cell engager targeting ROR1 and CD3 that could be used to treat both blood cancers and solid tumours. 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, delivering safer treatments for cancer patients without sacrificing therapeutic efficacy.

„The successful manufacture of NVG-222 marks a major milestone in our journey to bring safer, more effective immuno- therapies to patients. Our collaboration with Mabion, a trusted CDMO partner, has been characterised by exceptional tech- nical execution, a shared commitment to quality, and a mutual drive to deliver innovative therapies that truly impact patient lives. 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 to accelerate the delivery of transformative solutions for patients with high unmet medical need” – adds professor Amit Nathwani, Founder and CEO of NovalGen.