Mabion Participates in Groundbreaking Clinical Trial of Self-Regulating Immunotherapy
Mabion, a leading Polish biotechnology company and CDMO specializing in biologics manufacturing, proudly announces that the NVG-222 therapy, manufactured by Mabion and developed by NovalGen, has been approved for clinical evaluation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This is the world’s first therapeutic candidate equipped with AutoRegulation (AR) technology to enter a clinical trial. NovalGen has received authorization to conduct the study in the United Kingdom.
The MHRA’s acceptance of the NVG-222 clinical trial application represents a transformative moment for patients with hard-to-treat blood cancers. NVG-222 is not just a next-generation T cell engager – it is the first step towards a new era of self-regulating immunotherapies designed to work in harmony with the immune system.
Amit Nathwani, Founder and CEO of NovalGen
The collaboration between Mabion and NovalGen on NVG-222 highlights Mabion’s transformation into a world-class biologics CDMO. The partnership – initially announced in August 2024 – involved an intensive technology transfer and development program to scale up NVG-222’s complex manufacturing process at Mabion’s facilities. By June 2025, Mabion had successfully completed the transfer and released the first clinical batch of NVG-222, demonstrating excellent technical execution and quality compliance. Company leaders cite this accomplishment as “clear evidence of our operational maturity and our transformation into a world-class CDMO”, noting that Mabion’s strengthened manufacturing capabilities and quality systems now enable it to support global clients in bringing cutting-edge therapies to the clinic.
Through Mabion’s role, the innovative design and therapeutic promise of NVG-222 are being translated from lab to clinic for the first time. NVG-222 is a next-generation bispecific T-cell engager that binds ROR1 on cancer cells and CD3 on T cells, redirecting the immune system to attack ROR1-positive malignancies. Uniquely, it incorporates NovalGen’s proprietary AutoRegulation mechanism, which allows the drug to self-regulate T-cell activation. This built-in safety switch is designed to reduce life-threatening toxicities (like excessive cytokine release) while preserving long-term T-cell fitness and preventing exhaustion from chronic stimulation. By improving the therapeutic index in this way, NVG-222 aims to deliver potent anti-tumor effects with fewer side effects. Importantly, the concept has been clinically de-risked by an earlier NovalGen molecule, NVG-111, which shares the same ROR1 and CD3 targeting domains (but lacks AR) and has already shown encouraging activity in patients with blood cancers.
NovalGen’s next-generation AutoRegulating bispecific T-cell engager is set to transform cancer immunotherapy. At Mabion, we are proud of our partnership with NovalGen that has successfully brought this groundbreaking therapy to Phase I/II clinical trials.
Nigel Stapleton, VP of Business Development – Head of Europe in Mabion
Jakub Knurek is a marketing and business development expert specializing in CDMO operations with scientific and biopharmaceutical background. During the COVID-19 pandemic, he contributed to the development of the Novavax protein vaccine. As a side project, he runs his own pharma company.
As the author of numerous articles, he is recognized as an important voice of the younger generation of scientists. He is a member of Mabion’s representation at industry trade shows, including BIO International Convention 2025 in Boston, 2nd Global Biologics India 2025 in Hydrabad, CPHI 2024 in Milan, CPHI 2023 in Barcelona, Life Sciences Baltics 2023 in Vilnius. He actively participates in academic, business and industry discussions, such as the “Building the Future Pharma Workforce” panel at CPHI Milan 2024.
Sources and further reading
NovalGen. NovalGen to Begin World’s First Clinical Trial for a Self-Regulating Immunotherapy. 2025.
GlobalNewswire. NovalGen to Begin World’s First Clinical Trial for a Self-Regulating Immunotherapy. 2025.
Cancer Research Horizons. NovalGen to begin world’s first clinical trial for a self-regulating immunotherapy. 2025.
FAQ
NVG-222 is a next-generation bispecific T-cell engager, designed to activate the immune system only when needed, with the goal of improving safety and minimizing the toxic side effects often associated with immunotherapies.
The AutoRegulation Technology enables precise control of T-cell activation, reducing the risk of “over-stimulation” or exhaustion of T cells under chronic stimulation – a major hurdle to the durability of many immunotherapies.
Mabion is responsible for the manufacturing of NVG-222 under its biologics CDMO capabilities, as part of the licensing and development collaboration with NovalGen. Manufacturing covers both drug substance (DS) and drug product (DP) stages, fully compliant with GMP standards to ensure quality and patient safety.
The first dose of the drug is expected in the fourth quarter of 2025. The Phase I/II clinical trial is an adaptive basket trial targeting patients with ROR1-expressing hematological malignancies. The study will be sponsored and managed by Cancer Research UK’s Centre for Drug Development.
