NovalGen opens new chapter for cancer treatment as first patient dosed with its T-cell engager technology

Cancer Research UK’s Centre for Drug Development (CDD) and UCLB spinout venture, NovalGen, have announced the first patient has been dosed in a Phase 1 clinical trial of NVG‑222 – a next‑generation T‑cell engager for ROR1‑positive blood cancers.

A breakthrough built on collaboration

The therapeutic, called NVG‑222, is a type of immunotherapy designed to bring T-cells into contact with cancer cells. It does this by attaching to two targets at once: ROR1, which is found on some blood cancer cells, and CD3, which is found on T-cells.

NVG‑222 is the first medicine candidate made using NovalGen’s AutoRegulation technology, designed to help control an over‑active immune response, a common problem with T‑cell therapies, while keeping T-cells working for longer.

The aim is to lower the risk of side effects and reduce “T‑cell exhaustion”, which can make treatments stop working as well over time.

From concept to clinic: UCLB’s role

UCLB worked closely with Professor Amit Nathwani and the NovalGen team to ensure NVG‑222’s underlying technology could be robustly protected, strategically positioned and commercially ready for development.

This is core to what UCLB does: helping researchers understand the full value of their idea, build a viable commercial pathway and connect with the right partners to bring life‑changing innovation to patients.

The Phase 1 trial is sponsored and run by Cancer Research UK’s Centre for Drug Development. It is being led by Chief Investigator Dr Will Townsend at University College London Hospitals NHS Foundation Trust (UCLH), where the first patient has already received treatment..

The trial is now enrolling further patients across the UK with ROR1‑positive blood cancers. The study uses an adaptive design, which means the team can use what they learn during the trial to adjust things like dose levels, treatment timing and which biological signals (biomarkers) they track, to find the safest and most effective way to administer NVG‑222.

Dr. Richard Fagan, Director of BioPharm, UCLB, said: “This is an important milestone for Novalgen and an exciting stage for NVG-222 on its journey from lab to clinic. UCLB supported NovalGen’s partnership with Cancer Research UK to advance NVG‑222 and established the company as a spinout in 2019 to license and commercialise the exciting immunotherapy research of Prof Amit Nathwani and colleagues at UCL. We eagerly await the outcome of this and subsequent stages of the clinical trials.”

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, added: “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 technology senses and responds 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 UCLH, said: “This represents the start of the next chapter in 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.”