Ariceum Therapeutics Commences Phase 1 Clinical Trial in Patients with Recurrent Glioblastoma

• Novel iodine radiolabelled PARP inhibitor (rPARPi) entering clinical development in Phase 1 trial to assess safety and early efficacy
• Dose escalation study followed by expansion cohorts in recurrent glioblastoma with potential to move into primary glioblastoma

BERLIN, July 25, 2024 /PRNewswire/ -- Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announces that it has commenced a Phase 1 first-in-human clinical trial (CITADEL-123) of ¹²³I-ATT001, its Iodine-123 labelled PARP inhibitor, in patients with recurrent glioblastoma.

The trial opened at University College London Hospitals (UCLH) and will assess the safety and early efficacy of Ariceum's radiotherapeutic candidate, ATT001. UCLH consultant medical oncologist, Dr Paul Mulholland, designed the trial and is also chief investigator of the study. Ariceum is the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma, an aggressive form of brain cancer with a high unmet medical need.

The initiation of the Phase 1 clinical trial follows Ariceum's submission of a Clinical Trial Authorisation (CTA) application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in December 2023 and subsequent approval received from the MHRA in February 2024. The trial has commenced at UCLH, with other sites due to open in the UK and EU later this year. The dose escalation study will be followed by expansion cohorts at a recommended dose in monotherapy and in combination with other therapies in recurrent glioblastoma, with the potential to move into primary glioblastoma.

Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "The start of this clinical trial marks a significant clinical milestone for Ariceum's targeted radionuclide therapy, ATT001, especially so soon after receiving approval from the MHRA. We are very pleased to have begun the trial and hope it will bring a much-needed therapy to patients affected by glioblastoma, an aggressive and devastating form of brain cancer."

Germo Gericke, Chief Medical Officer at Ariceum Therapeutics, commented: "Recurrent glioblastoma is a very challenging brain cancer with currently no cure and limited treatment options. Ariceum's radiotherapeutic, ATT001, has demonstrated promising pre-clinical results as a potential treatment for patients. We hope to achieve further favourable results in the clinic from our continued collaboration with the team at UCLH, led by Dr Paul Mulholland."

Dr Paul Mulholland, who leads the Glioblastoma Research Group at the UCL Cancer Institute, added: "We have been working with Ariceum Therapeutics for some years to develop this study. It will allow us to deliver a low level of radioactivity directly into the tumour of patients with recurrent glioblastoma. I'm very pleased that this clinical trial is now opening."

ATT001 delivers its radioisotope payload, Iodine-123, in a highly targeted way to cancer cells expressing PARP, an enzyme they use to repair their DNA. This radioisotope emits low energy Auger electrons, which deposit their energy over short distances, making them particularly useful for causing lethal damage to cancer cells while sparing healthy tissue. An additional benefit of using Iodine-123 is that this isotope is more widely available than others, being produced in a cyclotron. Ariceum in parallel is also exploring ¹²³I-ATT001 in other solid tumour indications, as PARP is a validated target, highly expressed in several other cancers.

Notes to Editors

About Ariceum Therapeutics

Ariceum Therapeutics (Ariceum) is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of 'Marie Curie' whose discovery of radium and polonium have been huge contributions to finding treatments for cancer.

Ariceum's lead targeted systemic radiopharmaceutical product, 177Lu-satoreotide tetraxetan ("Satoreotide"), is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), or Merkel Cell Carcinoma, all of which have few treatment options and poor prognosis. Satoreotide is being developed as a 'theranostic' pair for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), which is slated to enter clinical development in 2024. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023.

Ariceum Therapeutics, launched in 2021, acquired all rights to Satoreotide from Ipsen. Ipsen remains a shareholder in the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, United Kingdom and United States of America and with activities currently across the globe.

Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners and Earlybird Venture Capital. For further information, please visit  www.ariceum-therapeutics.com.