In July 2023 IO Biotech announced that the University of California Davis Comprehensive Cancer Centre has dosed the first patient in an investigator-initiated trial of IO102-IO103. IO Biotech uses its T-win technology platform to develop novel, immune-modulating cancer vaccines like IO102-IO103, an investigational immune-modulating cancer vaccine. This is being tested in combination with pembrolizumab in patients with BCG-unresponsive or intolerant, non-muscle invasive bladder cancer (NMIBC). The trial is one of five investigator-initiated trials for IO Biotech to evaluate the vaccine in combination with different checkpoint inhibitor-based regimens across a range of cancer types.  

Bladder cancer 

Bladder cancer occurs when a growth of abnormal tissue, a tumour, develops in the bladder lining, or occasionally spreads to the bladder muscle. The NHS suggests that the most common symptom of bladder cancer is blood in urine. Once diagnosed, the cancer can be classified by how far it has spread; the most common type is non-muscle-invasive bladder (early bladder cancer). This is where the cancerous cells are contained within the lining of the bladder.  

When the cancerous cells spread beyond the lining, into the surrounding bladder muscle, it is described as muscle-invasive bladder cancer (invasive bladder cancer). It is less common but has a higher chance of spreading to other parts of the body. When this spread occurs, it is known as advanced or metastatic bladder cancer.  Most cases of bladder cancer seem to have been caused by “exposure to harmful substances”, such as tobacco smoke. More than 1 in 3 cases of bladder cancer are caused by smoking. These substances lead to abnormal changes in the bladder’s cells over time.  

Dr Mamta Parikh, Associate Professor at the UC Davis School of Medicine, Division of Haematology Oncology, and PI for the clinical trial, commented that “bladder cancer is one of the most common forms of cancer”. 

“There remains a critical unmet need for these patients who may be averse to invasive bladder removal surgery or unresponsive to currently available therapies.”  

IO102-IO103 is designed to target the immunosuppressive mechanisms mediated by proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1. It is already being investigated in a Phase III trial in combination with pembrolizumab in first-line advanced melanoma patients. It is also in a Phase II basket trial to investigate safety and efficacy in combination with pembrolizumab for the first-line treatment of non-small cell lung cancer, squamous cell carcinoma of the head and neck, and urothelial bladder cancer.  

Dr Mai-Britt Bocca, President and CEO of IO Biotech is pleased to support the trial.  

“In previous trials, we have seen that combination therapies with our lead product candidate, IO102-IO-103, induce meaningful tumour regression while still achieving manageable tolerability for patients.”  

Dr Bocca looks forward to the results “to further support the development” of the vaccine as the “potential backbone of combination therapies for treating multiple types of cancer”.  

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