Cancer Research UK announces dosing of first patient in Phase 2 trial with ginisortamab therapy

Cancer Research UK announced today (30 Aug) that the first patient has received treatment in a new Phase 2 clinical trial.  

The ginisortamab (UCB6114) study is designed to evaluate ginisortamab*,  an anti-gremlin-1 monoclonal antibody therapy, in patients with pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. The study has opened in Glasgow and Edinburgh, with further sites planned as the trial progresses. 

Current therapy options have limited success for the majority of people diagnosed with PDAC so newer and more effective ways of treating this type of cancer are needed. 

Ginisortamab works to restore tumour-suppressing processes that have become disrupted by growing cancer cells.  

The tumour stroma (part of the microenvironment surrounding a cluster of cancer cells) produces a protein called gremlin-1. Gremlin-1 interferes with signalling processes controlled by bone morphogenic proteins (BMPs), which would normally limit the expansion of a tumour, among other roles.**  

High gremlin 1 levels are associated with poor outcomes across a range of solid tumours, including PDAC. Ginisortamab is an antibody therapy designed to block the activity of gremlin-1 produced by the tumour.  

The first part of the study has opened which is designed to evaluate the effectiveness of ginisortamab given with nab-paclitaxel and gemcitabine therapy. Positive results from the trial could lead to further expansion of the study to evaluate other therapies in combination with ginisortamab. 

Prof Jeff Evans is the Chief Investigator leading the trial. Patient recruitment opened in the UK at the Beatson West of Scotland Cancer Centre in Glasgow, with plans for additional sites to open across the UK and internationally as the study progresses. 

Professor of Translational Cancer Research at the University of Glasgow, Prof Jeff Evans, said:  

“It is great news that we have started giving this treatment to patients enrolled in this study. Pancreatic cancers are very challenging to treat, and patients deserve better treatment options. We look forward to seeing how this trial progresses to investigate whether ginisortamab is a tolerated and effective treatment for patients with pancreatic cancer.” 

Director of Cancer Research UK’s Centre for Drug Development, Dr Lars Erwig, said:  

“Industry partners kindly licensing use of their promising therapies, combined with the Centre for Drug Development’s unique capabilities and expertise in facilitating clinical trials, helps to investigate more cutting-edge agents, like ginisortamab, sooner for patients. We are also grateful to the patients who have volunteered to be part of this trial and look forward to seeing how the study progresses.” 

Pancreatic cancer is the 10th most common cancer in the UK, with around 10,500 people diagnosed each year. Pancreatic cancers have poor survivorship with only around 5% of people surviving their cancer 10 years or more post-diagnosis.*** 

The clinical development of ginisortamab (UCB6114) is part of a multi-year and multi-project collaboration with UCB, a global biopharmaceutical company, and Cancer Research UK’s Centre for Drug Development. Under the collaboration, Cancer Research UK are exclusively responsible for the design, sponsorship and delivery of the trial while UCB will manufacture and provide ginisortamab for the trial. UCB retains exclusive rights to further develop and commercialise ginisortamab and will receive a licence to the results of the clinical trials from Cancer Research UK in return for undisclosed success-based milestone and royalty payments. 

ENDS   

Prof Jeff Evans, Dr Lars Erwig and other Cancer Research UK spokespeople are available for interview. For media enquiries, contact Fiona Scott in the Cancer Research UK press office on 020 3469 5128 or, out of hours, on 020 3469 8301.   

*Sarker D, Banerji U, Blagden SP, et al. A multi-modular phase I/II study of UCB6114, a first-in-class, fully human IgG4P anti-Gremlin-1 monoclonal antibody, as monotherapy and in combination with mFOLFOX6 or trifluridine/tipiracil, for patients with advanced gastrointestinal (GI) tumors. J Clin Oncol. 2022;40(4):Suppl.TPS221.  

**The tumour stroma is composed of extracellular matrix and specialized connective tissue cells, including fibroblasts and mesenchymal stromal cells. Valkenburg KC, de Groot AE, Pienta KJ. Targeting the tumour stroma to improve cancer therapy. Nat Rev Clin Oncol. 2018;15:366-381. 

***https://www.cancerresearchuk.org/about-cancer/pancreatic-cancer.  

• Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research, influence and information.   
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• Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK wants to accelerate progress and see 3 in 4 people surviving their cancer by 2034.   
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Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 16 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. 

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