The first patient has been dosed in a treatment for ROR1-positive blood cancers. 

NVG-222 is a bispecific T-cell engager targeting ROR1 and CD3, developed by biotechnology company NovalGen. 

The drug is the first therapeutic candidate to use NovalGen’s proprietary AutoRegulation technology, an 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 Phase I clinical trial is being sponsored and delivered by Cancer Research UK’s Centre for Drug Development and led by Chief Investigator William Townsend at University College London Hospitals NHS Foundation Trust (UCLH), where the first patient received treatment.  

 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. 

“The start of this Phase I trial is a defining moment for NovalGen and the patients we serve,” said Professor Amit Nathwani, Founder and CEO of NovalGen. 

“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.” 

“Dosing the first patient is an important milestone for our collaboration with NovalGen,” added Dr Lars Erwig, Director of the Centre for Drug Development at Cancer Research UK. 

“NVG222 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.”