Cancer Research UK’s Centre for Drug Development (CDD) and NovalGen today announce that the first patient has been dosed in a Phase 1 clinical trial evaluating NVG‑222, NovalGen’s next-generation self‑regulating T‑cell engager for the treatment of ROR1‑positive blood cancers.

NVG‑222 is a bispecific T‑cell engager targeting ROR1 and CD3 and is the first therapeutic candidate to use NovalGen’s proprietary AutoRegulation technology, a key innovation designed to mitigate excessive immune activation and cytokine-mediated toxicities, while maintaining sustained T-cell function and reducing exhaustion associated with continuous stimulation.

The trial is sponsored and delivered by Cancer Research UK’s Centre for Drug Development and is led by Chief Investigator Will Townsend at University College London Hospitals NHS Foundation Trust (UCLH), where the first patient received treatment. Cancer Research Horizons is managing the commercial partnership between NovalGen and Cancer Research UK.

The study is enrolling patients across the UK with ROR1‑positive blood cancers and uses an adaptive design to optimise dose, treatment and biomarker strategies. Dosing of the first patient marks an important step in translating AutoRegulated immune therapies from the laboratory into clinical testing.

Dr Lars Erwig, Director of the Centre for Drug Development at Cancer Research UK, said: “Dosing the first patient is an important milestone for our collaboration with NovalGen. NVG‑222 reflects the kind of innovative, safety‑focused immunotherapy we aim to advance, and we’re proud to help bring this next‑generation treatment into the clinic.”

Professor Amit Nathwani, Founder and CEO of NovalGen, said: “The start of this Phase 1 trial is a defining moment for NovalGen and the patients we serve. With support from CRUK, we are moving towards a future of ‘intelligent’ biologics. Our AutoRegulation (AR) technology is designed to sense and respond to the biological environment in real-time, aiming to overcome the toxicity and exhaustion hurdles that have historically limited T-cell based immunotherapies. NVG-222 marks the beginning of our mission to set a new standard for precision, potency and safety in next-generation immunotherapy.”

Dr William Townsend, Consultant Haematologist at University College London Hospitals NHS Foundation Trust, said: “This represents the start of the next chapter in the story of T-cell engaging strategies to treat blood cancers. It is exciting to be part of this Phase 1 clinical trial which shows the best of UK research and clinical trial delivery. I hope it will translate into tangible benefits for our patients.”

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About Cancer Research UK’s Centre for Drug Development (CDD) 
Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years. It has completed over 170 clinical trials designed to explore potential new anti-cancer agents in patients. Six of these new agents have made it to market, including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. www.cruk.org.uk/cdd 

About NovalGen
NovalGen is a London-based biotechnology company pioneering next-generation immunotherapies built on its proprietary AutoRegulation (AR) platform. AR introduces real-time, context-dependent control of immune activation, aiming to preserve potent therapeutic activity whilst reducing the toxicities and functional exhaustion that limit current T-cell-based treatments.

At the heart of NovalGen’s approach is the belief that immune therapies should be both powerful and precisely controlled. The AR platform is modular, versatile and modality-agnostic, enabling its integration not only into T-cell engagers such as NVG-222, but also into emerging multispecific architectures and future immune-activating modalities across oncology, haematology and autoimmune disease.

NovalGen leads discovery and translational development from platform design through early clinical testing, advancing a pipeline that includes AR-enabled next-generation multispecific T-cell engagers and biologics. Through collaborations with academic and industry partners, the company is expanding the reach of AutoRegulation to unlock safer, more durable and more accessible immunotherapies for patients worldwide. www.novalgen.com 

About Cancer Research UK:  

• Cancer Research UK is the world’s leading cancer charity dedicated to saving and improving lives through research, influence and information.   
• Cancer Research UK’s pioneering work into the prevention, detection and treatment of cancer has helped save millions of lives.    
• Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double over the past 50 years.    
• Cancer Research UK supports research into the prevention and treatment of cancer through the work of over 4,000 scientists, doctors and nurses.   
• Together with its partners and supporters, Cancer Research UK is working towards a world where everybody can live longer, better lives, free from the fear of cancer.   

For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on X and Facebook