NovalGen to collaborate with CRUK to progress NVG-222 into a Phase I clinical study
NovalGen to collaborate with CRUK to progress NVG-222 into a Phase I clinical study
NVG-222 is a revolutionary new therapy possessing an in-built “off switch” to limit toxicity during the treatment of multiple malignancies. The drug has been developed by NovalGen and will enter the clinic in a Phase I study in collaboration with CRUK in 2025.
NVG-222 is equipped with NovalGen's proprietary AutoRegulation (AR) technology which enables biologics to self-deactivate in response to emerging toxicity, offering safer and more efficacious immunotherapies. This innovative approach is particularly valuable for bispecific and multispecific antibodies, such as T cell engagers (TCEs), which are prone to cytokine-mediated toxicities.
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.
About NovalGen's AutoRegulation Technology
Immunotherapies have revolutionised medicine, but their effectiveness is often hampered by mechanism-of-action (MOA) associated toxicities that limit their therapeutic utility and compromises patient outcomes. NovalGen's AR technology is a breakthrough in immunotherapy. By equipping biologics with the ability to self-regulate, AR can mitigate MOA-related toxicities and enhance therapeutic efficacy. This approach has several advantages:
- Improved Safety: AR reduces the risk of MOA-induced side effects, allowing for safer and more tolerable treatments with a wider therapeutic index.
- Enhanced Efficacy: By minimising toxicity, AR enables higher dosing and longer treatment durations, potentially leading to improved clinical outcomes.
- Wider Accessibility: AR expands the range of patients who can benefit from immunotherapy by reducing the risk of adverse events.
About NovalGen's Pipeline
NovalGen is developing a pipeline of AR-enabled biologics targeting various diseases. Here are some key programmes:
- NVG-222: This half-life extended TCE targeting ROR1 is entering a Phase I clinical trial in Q1/Q2 2025 ion collaboration with CRUK. It is designed to treat a range of haematological and solid tumours and is expected to provide initial clinical readout in 1H 2026.
- NVG-666: This next-generation AR TCE is being developed for the treatment of autoimmune disorders. By selectively targeting CD19, NVG-666 can induce deep B cell depletion while minimising toxicity, thus enabling immunosuppression free, durable remission. It is primed for entry into the clinic in Q4 2025.
- AR TCEs with Target-Specific Binding: NovalGen is exploring TCEs that possess both AR and the ability to bind targets only within the tumour microenvironment. This approach can address on-target, off-tumour toxicities and further enhance safety and efficacy.
Non-TCE programmes:
- NVG-555: A bispecific checkpoint inhibitor (CPI) that antagonises two independent checkpoint pathways for a synergistic enhancement of efficacy. AR prevents the known additive toxicities with CPI approaches.
- NVG-444: A UKRI-funded bispecific factor VIII mimetic antibody for the treatment of haemophilia A. The use of AR prevents the MOA toxicities that impact this class of antibodies that can results in thromboembolic events and microangiopathies.