Ariceum Therapeutics Begins Phase 1 Trial for Recurrent Glioblastoma

Ariceum Therapeutics, a private biotechnology firm specializing in radiopharmaceutical products for tough-to-treat cancers, has initiated a Phase 1 clinical trial (CITADEL-123) for its Iodine-123 labelled PARP inhibitor, 123I-ATT001, in patients with recurrent glioblastoma. This trial, a first-in-human study, has commenced at University College London Hospitals (UCLH) and aims to evaluate the safety and early efficacy of ATT001.

UCLH consultant medical oncologist, Dr. Paul Mulholland, is the chief investigator of the study and has been instrumental in its design. This trial makes Ariceum the pioneer in sponsoring a clinical investigation of Auger therapy for recurrent glioblastoma, a highly aggressive brain cancer with significant unmet medical needs.

The launch of this clinical trial follows the submission of a Clinical Trial Authorisation (CTA) application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in December 2023. Approval was received from MHRA in February 2024. Initially opening at UCLH, the trial is anticipated to expand to other sites within the UK and the European Union later this year.

The trial involves a dose escalation study, followed by expansion cohorts at a recommended dose in monotherapy and in combination with other therapies for recurrent glioblastoma, with the potential to extend into primary glioblastoma.

Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, expressed his satisfaction with the trial's initiation, noting it as a significant clinical milestone for Ariceum's targeted radionuclide therapy, ATT001. He emphasized the hope that this trial brings a needed therapy to glioblastoma patients, who face a particularly aggressive and devastating form of brain cancer.

Germo Gericke, Chief Medical Officer at Ariceum Therapeutics, highlighted the challenges associated with recurrent glioblastoma, a brain cancer with no current cure and limited treatment options. He pointed out that ATT001 has shown promising pre-clinical results as a potential treatment, and he hopes for favorable clinical outcomes from ongoing collaborations with the UCLH team led by Dr. Paul Mulholland.

Dr. Paul Mulholland, leading the Glioblastoma Research Group at the UCL Cancer Institute, expressed his satisfaction with the trial's commencement. He mentioned that the study would enable the delivery of low-level radioactivity directly into the tumor of patients with recurrent glioblastoma.

ATT001 administers its radioisotope payload, Iodine-123, in a targeted manner to cancer cells expressing PARP, an enzyme that aids in DNA repair. This radioisotope emits low-energy Auger electrons, which release their energy over short distances, making them effective in causing lethal damage to cancer cells while sparing healthy tissue. An advantage of using Iodine-123 is its broader availability, being produced in a cyclotron. Ariceum is also investigating 123I-ATT001 for other solid tumors, given that PARP is a validated target expressed in various cancers.

Ariceum Therapeutics was launched in 2021 and acquired all rights to Satoreotide from Ipsen. Ipsen remains a shareholder in the company. Headquartered in Berlin, Ariceum operates in Germany, Switzerland, Australia, the United Kingdom, and the United States, with activities spanning the globe. The company's management team is experienced and supported by specialist investors such as EQT Life Sciences, HealthCap, Pureos Bioventures, Andera Partners, and Earlybird Venture Capital.