European biologics CDMO Mabion has entered into a strategic development and manufacturing partnership with London-based NovalGen to advance NVG-222, a novel bispecific T-cell engager, toward phase one clinical trials scheduled to begin in the second half of 2025. The partnership represents a significant step forward in the global fight against blood cancers and hard-to-treat solid tumors.
Revolutionary T-Cell Engager Technology
NVG-222 is a bispecific T-cell engager that targets both ROR1 and CD3, positioning it as a potential treatment for both hematologic malignancies and solid tumors. The therapeutic distinguishes itself as the first agent to incorporate NovalGen's proprietary AutoRegulation (AR) technology, which is specifically designed to mitigate toxicity, improve efficacy, and expand the therapeutic index of T-cell engagers.
According to Professor Amit Nathwani, Founder and CEO of NovalGen, this technology "offers the potential for a paradigm shift in immuno-oncology therapies, delivering safer treatments for cancer patients without sacrificing therapeutic efficacy."
Manufacturing Milestone Achieved
The partnership has already achieved a critical milestone with the successful release of the first clinical batch of NVG-222. This accomplishment demonstrates the successful technology transfer and manufacturing process implementation between the two companies.
"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 Julita Balcerek Ph.D, Chief Operating Officer of Mabion S.A. "All this is surrounded by a quality system that has been verified by NovalGen in a successful quality audit."
Strategic CDMO Transformation
The partnership reflects Mabion's strategic transformation into a contract development and manufacturing organization (CDMO), which began in 2023 as part of their 2025-2030 Strategy. Balcerek emphasized that these achievements are "a direct result of Mabion's transformation into a CDMO" and noted that the company has "expanded our manufacturing capabilities and technology portfolio" while strengthening "business development and internal processes, enabling us to operate as a world-class CDMO."
Broader Pipeline Implications
The collaboration extends beyond NVG-222, providing a platform for future partnerships on NovalGen's broader pipeline of treatments in development. The pipeline includes promising candidates for both oncology and non-oncology indications, with NovalGen planning to initiate trials for a highly differentiated immunotherapy for autoimmune diseases by Q4 2025.
Professor Nathwani highlighted the partnership's significance, stating: "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 characterised by exceptional technical execution, a shared commitment to quality, and a mutual drive to deliver innovative therapies that truly impact patient lives."
Clinical Development Timeline
With the first batch now released, NovalGen is preparing for clinical trial initiation in the second half of 2025. The company, founded in 2019 and headquartered in London, has positioned itself as an immunotherapy pioneer with a focus on addressing critical unmet needs in oncology and autoimmune diseases through its proprietary autoregulation platform technology.
