Nuclidium secures grant to launch phase 1 clinical trial

Neuroendocrine tumours (NETs) are a rare form of cancer that develops in cells of the neuroendocrine system located mainly in the gastrointestinal tract and the pancreas. Often asymptomatic and difficult to detect, they are usually only diagnosed at an advanced or metastatic stage associated with significantly reduced survival rates. In addition, up to 50% of NET patients are wrongly staged, preventing them from receiving the right treatment. Like prostate cancer, the survival rate significantly drops the more advanced or metastasised the tumour is (5-year survival for metastatic pancreatic NETs: 24 %). Available therapeutics for advanced NET, including chemotherapy and targeted radiotherapy, are still facing challenges like toxic side effects, limited efficacy and availability.

Swiss startup Nuclidium (formerly Swiss Nuclides AG), through its program TraceNETTM aims to overcome key limitations of existing radiodiagnostics and their corresponding therapeutics by increasing the sensitivity and diagnostic accuracy of NET imaging, including detecting metastases, while reducing the radiation burden for the patient. The TraceNETTM diagnostic consists of an imaging radioisotope (61Cu) and a somatostatin receptor (SSTR) antagonist-targeting molecule that binds with high affinity and specificity to SSTRs overexpressed on the surface of NET cells.

First-in-human trials scheduled for 2023
Nuclidium and the University Hospital Basel (USB) have been awarded the Investigator Grant to support the clinical development of TraceNETTM. The two organisations will combine their know-how and resources for a first-in-human study with TraceNETTM on their joint mission to provide NET patients with a new diagnostic that offers improved precision, performance, and accessibility. The Phase 1 study will assess the safety, biodistribution, pharmacokinetics and dosimetry of TraceNETTM in NET patients. It will also analyse the performance of TraceNETTM in positron emission tomography (PET)/computed tomography (CT) imaging compared to 68Ga-DOTATOC, the current state-of-the-art imaging agent for the detection of NET in the same patients. The study will kick off in the first half of 2023.

“The Investigator Award underlines the unique potential of our copper-based theranostic approach that, for the first time, allows the development of a true theranostic, leveraging the same radiometal and targeting molecule. There is a persistent need for better theranostics to ensure the best possible care for NET patients at all stages of their disease. Together with the USB, our vision is to set a new standard in precision oncology by enabling easy access to highly effective and safe diagnostics and treatment options for cancer patients. We are looking forward to rapidly advancing our first program TraceNETTM into a first-in-human trial only 1,5 years after we initiated its development,” said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM.

About the Investigator grant
Organised by the Neuroendocrine Tumors Research Foundation (NETRF), the  Investigator Award aims to support innovative and transformative research projects to help bring the NET field closer to more effective therapies. It encourages multidisciplinary groups comprised of basic scientists, clinicians and experts across relevant cutting-edge areas to jointly apply their know-how to developing novel ideas and strategies to improve the lives of NET patients. The Investigator Award is granted to one or two applicants each year and supports projects for two years.

(Press release)