Early signals from an ongoing study at The Christie Hospital in Manchester shore up the evidence for an investigational treatment for the most common form of bladder cancer (urothelial carcinoma).
The drug in the study – HMBD-001– is an anti-HER3 monoclonal antibody, being developed by Houston, Texas-based Hummingbird Biosciences. HMBD-001 is a targeted chemotherapy, which recognises and attaches itself to a protein located on the surface of some tumour cells.
Sponsored by Cancer Research UK, the Phase I/II trial (NCT05057013) is looking to establish the best dose of HMBD-001, to be administered either alone or in combination with other anti-cancer agents. It is further trying to establish the potential side effects of HMBD-001, as well as what happens to HMBD-001 inside the body and how it affects cancer cells.
The Christie has reported that patients showed promising results in dose escalation part A of the trial, recently sharing the example of 53-year-old bladder cancer patient Paul Simmonite from Trawden, UK. Paul’s cancer progressed despite receiving chemotherapy and immunotherapy, but the weekly, intravenously administered HMBD-001 has seen his cancer reduce by over 60% in his liver. As part of the investigational treatment protocol, the pelvis area was treated with radiotherapy and the tumour on the lymph node was reduced by three-quarters its original size, making it barely visible on scans.
Dr. Louise Carter, consultant oncologist leading the clinical trial at The Christie spoke on the implications of this early result: “This clinical trial indicates that this new experimental drug could deliver promising results for bladder cancer patients, and potentially for other cancers.”
She added that, “Almost half of the patients with bladder cancer who took part in the study benefited from the treatment, and it was generally well tolerated, with few side-effects. However, more research is needed to confirm these exciting results in a large group of patients. We are now planning to do further work with this drug in other cancer types including breast and lung cancer very soon.”
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By GlobalDataThe trial is also taking place at Royal Marsden Hospital in London, Freeman Hospital in Newcastle and the Churchill Hospital in Oxford.
Bladder cancer is the 11th most common cancer in the UK, accounting for 3% of all new cancer cases between 2017 and 2019, according to Cancer Research UK. According to GlobalData figures, it is the ninth most common cancer globally, with urothelial carcinoma being the most common form of bladder cancer, accounting for around 90% of cases.
GlobalData is the parent company of Clinical Trials Arena.
In a recent report, GlobalData noted that in the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and urban China), there were 279,419 diagnosed incident cases of bladder cancer in 2023. It forecasts that diagnosed incident cases will see an annual growth rate of over 2% across 2023-2033.
Relevant to this, the immuno-oncology and cancer therapeutics sector is set to see the strongest innovation pipeline in the next five years, according to results from a recent GlobalData survey, The State of the Biopharmaceutical Industry – 2025.
In the survey, of 128 respondents, most (41%) identified the area as the most likely to see strong innovation, with European respondents particularly expecting the sector to thrive.
Urte Jakimaviciute, senior director of market research and strategic intelligence in the healthcare division at GlobalData, commented that: “Advancements in immunotherapy such as checkpoint inhibitors, chimeric antigen receptor (CAR)-T cell therapies, cancer vaccines, etc., are revolutionising the way cancer is treated, and as these therapies evolve, they may lead to more effective and personalised treatments. Further to this, high unmet needs in cancer with many types of indications lacking effective treatments are driving and will continue to drive the innovation in immuno-oncology and cancer therapeutics.”