NovalGen to Begin World’s First Clinical Trial for a Self-Regulating Immunotherapy

September 17, 2025 at 09:00 AM EDT

LONDON, Sept. 17, 2025 (GLOBE NEWSWIRE) -- 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.”

About NovalGen

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. As part of our vision to become a leading biotech company, NovalGen is committed to working with patient organizations, healthcare providers, governments, and communities to ensure equitable access to affordable and reliable healthcare globally. www.novalgen.com

About Cancer Research UK’s Centre for Drug Development

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. https://www.cancerresearchhorizons.com/our-translational-science/cancer-research-uk-centre-drug-development

About Mabion

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. For more information about Mabion, please visit www.mabion.eu.

Contact:

Fiona Beveridge, fiona.beveridge@opyn.consulting, 07729 613997