Novalgen Ltd.

Sept. 17, 2025 -- 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. The Phase I/II adaptive basket study will be sponsored and managed by Cancer Research UK’s Centre for Drug Development (CDD) and will enrol patients across the UK with a range of ROR1-positive haematological malignancies. First patient dosing is expected in Q4 2025. 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.” NovalGen, a London-headquartered immunotherapy pioneer founded in 2019, is dedicated to transforming patient lives through cutting-edge innovations. At the core of its research is a proprietary AutoRegulation platform technology, driving the development of next-generation immunotherapies with enhanced safety and efficacy through its in-built precision control of immune cell activation. Our unique drug discovery approach has yielded a robust and diverse pipeline addressing critical unmet needs in oncology and autoimmune diseases. Our lead programme, NVG-222, is set to enter clinical development in Q4 2025. Cancer Research UK has an impressive record of developing novel treatments for cancer. The Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 170 potential new anti-cancer agents into clinical trials 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. Two other drugs are in late development Phase 3 trials. Thirteen agents remain in active development with the potential to reach the market. It currently has a portfolio of 16 projects in preclinical development, Phase 1, or early Phase 2 clinical trials. Mabion S.A. (WSE: MAB) is a Polish biopharmaceutical company founded in 2007. In 2023–2024, the company underwent a strategic transformation into a biologics-focused Contract Development and Manufacturing Organization (CDMO), offering an integrated range of services. Mabion provides a broad spectrum of CDMO solutions for small and mid-sized projects across various stages of development – from early-stage cell line development to commercial manufacturing. The company’s core competencies include monoclonal antibody and recombinant protein technologies (based on both mammalian and insect cell expression systems), advanced analytical capabilities, as well as the production of both Drug Substances (DS) and Drug Products (DP). Mabion operates in accordance with globally recognized quality standards, including GMP and ISO. Mabion employs approximately 200 highly qualified professionals, including scientists, engineers and specialists in quality, manufacturing and analytical development of biologics. Headquartered in the heart of Europe, in Poland – a member state of the European Union – Mabion offers seamless access to highly regulated international markets. The company’s mission is to be a trusted global partner in the development and manufacturing of biologic medicines. Mabion is a publicly listed company, traded on the Warsaw Stock Exchange. The content above comes from the network. if any infringement, please contact us to modify.

In a significant move to accelerate the Global fight against blood cancers and hard- to-treat solid tumours, renowned end-to-end biologics company Mabion have entered into a strategic development and manufacturing partnership with London based NovalGen, to bring their proprietary T-cell engager, NVG-222 to market for phase one of in-human clinical trials; with initial outcomes expected by H2 2026. With the first batch drug released, this partnership signifies a pivotal moment in the development of next-generation immunotherapies, offering a potential new lifeline for cancer patients. Leveraging Mabion's progressive manufacturing and development capabilities to minimise risk in pharmaceutical production, the technology transfer, development and clinical compliance provides a platform for future collaboration on NovalGen’s pipeline of disruptive treatments in development, including promising candidates for both oncology and non-oncology indications. Link to Mabion Press Release Professor Amit Nathwani, Founder and CEO of NovalGen said: The successful manufacture of NVG-222 marks a major milestone in our journey to bring safer, more effective immunotherapies to patients. Our collaboration with Mabion, a trusted CDMO partner, has been characterised by exceptional technical execution, a shared commitment to quality, and a mutual drive to deliver innovative therapies that truly impact patient lives. As we prepare for clinical trial initiation in the second half of 2025 and continue progressing our pipeline, especially in oncology and autoimmune indications, we look forward to expanding our partnership with Mabion to accelerate the delivery of transformative solutions for patients with high unmet medical need.

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. Link to Press Release 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.