17th September 2025
NovalGen to Begin World’s First Clinical Trial for a Self-Regulating Immunotherapy
The world’s first therapeutic drug to be equipped with NovalGen’s pioneering AutoRegulation (AR) technology has been approved for evaluation in the clinic by the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA)
NVG-222, a next-generation, AutoRegulating T cell engager has been developed to increase the safety and durability of immunotherapies; and following confirmation of Clinical Trial Authorisation (CTA) by the MHRA, it is set to begin clinical evaluation later this year.
NovalGen’s AR technology represents a significant advancement in immunotherapy. By addressing the limitations of current therapies, and we are now working to improve patient outcomes and expand the reach of this powerful therapeutic modality.
In entering clinical evaluation, NVG-222 which is manufactured under licence agreement by Polish-based company Mabion, marks a major milestone for cancer research and patients. Built on NovalGen’s proprietary AR platform, NVG-222 introduces precision control of immune activation. This novel mechanism reduces the risk of life-threatening toxicities, while crucially preserving long-term T cell fitness and reducing the risk of exhaustion from chronic stimulation—an innovation designed to fundamentally change the safety and durability of immunotherapies. Now, through the CDD’s unique expertise and track record of advancing novel treatments into the clinic, this breakthrough technology is being translated from the laboratory into patients for the very first time.
Beyond its AR-enabled safety profile, NVG-222 holds broad therapeutic potential as it targets ROR1, a protein expressed across multiple malignancies, including several blood cancers. Importantly, NVG-222 has been clinically de-risked by NVG-111, a precursor molecule with the same ROR1- and CD3-binding domains but without AR functionality, which has demonstrated encouraging activity in patients with haematological malignancies.
Professor Amit Nathwani, Founder and CEO of NovalGen, commented:
“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. We are proud to partner with Cancer Research UK, whose expertise and commitment to advancing novel therapies to patients is second to none. This first-in-human study would not be possible without the sponsorship and expertise of Cancer Research UK’s CDD, whose unparalleled commitment to pioneering therapies has brought countless innovations into the clinic.”
