• 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, Germany, 25 July 2024 – 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.

-Ends-

For further information, please contact:

Ariceum Therapeutics
Manfred Rüdiger, CEO
Email: info@ariceum-therapeutics.com

Optimum Strategic Communications
Zoe Bolt, Charlotte Hepburne-Scott, Elena Bates
Tel: +44 (0) 20 3882 9621
Email: ariceum@optimumcomms.com

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.

Berlin, Germany, 4 April 2024 – 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 will be presenting a poster, demonstrating its new findings on the discovery of novel macrocyclic peptide radioligands for tumor therapy by mRNA display in collaboration with research partner, UCB, a global pharmaceutical company, at this year’s American Association for Cancer Research (AACR) Annual Meeting, held 5-10 April 2024 in San Diego, California.

The findings describe the selection and initial characterization of macrocyclic peptides against an undisclosed target discovered using UCB’s mRNA-display technology platform, ExtremeDiversity™. Macrocyclic peptides are potent ligands for radioligand therapeutics (RLT) that aim to selectively deliver radioisotopes to cancer tissues to eradicate tumor cells while limiting the damage to surrounding tissues. This new data highlights the potential of UCB’s mRNA display platform for fast and efficient discovery of highly specific macrocyclic peptides with optimal binding properties suitable for RLT.

Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: “Following our exclusive, strategic research collaboration with UCB, we look forward to presenting new findings related to the identification of highly specific macrocyclic peptides for use in radioligand therapeutics at this year’s AACR Annual Meeting. These data have positive implications for the future development of RLT and are a potential game-changer in precision cancer therapy. AACR’s Annual Meeting is the perfect industry forum at the forefront of cancer research at which to present our findings.”

Details of the poster presentation are as follow:

Title: Discovery of novel macrocyclic peptide radioligands for tumor therapy by mRNA display
Presenting Author: Anika Jaekel, Senior Director, Head of Translational Biology and Non-Clinical Pharmacology at Ariceum Therapeutics
Session Category: Experimental and Molecular Therapeutics
Session Title: Radiation, Theranostics, Radiotheranostics, Normal Tissue, and Cellular Stress
Session Date and Time: Tuesday 9 April 2024, 1:30 PM – 5:00 PM PDT
Location: Poster Section 29
Poster Board Number: 7
Abstract Number: 6025

Abstracts are available in an online itinerary planner here and will be available in on online only supplement to the AACR journal Cancer Research one month after the conference.

-Ends-

For further information, please contact:

Ariceum Therapeutics
Manfred Rüdiger, CEO
Email: info@ariceum-therapeutics.com 

Optimum Strategic Communications
Zoe Bolt, Charlotte Hepburne-Scott, Elena Bates
Tel: +44 (0) 20 3882 9621
Email: ariceum@optimumcomms.com

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.

About AACR

Founded in 1907, the American Association for Cancer Research (AACR) is the world’s first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes more than 54,000 laboratory, translational, and clinical researchers; population scientists; other health care professionals; and patient advocates residing in 130 countries and territories around the world. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, diagnosis, and treatment of cancer by annually convening more than 30 conferences and educational workshops, the largest of which is the AACR Annual Meeting. For more information about the AACR, visit AACR.org.

Berlin, Germany, 29^th February 2024 – Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, is pleased to announce that it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to undertake a Phase 1 clinical trial (CITADEL-123) of ¹²³I-ATT001, its Iodine-123 labelled PARP inhibitor, in patients with recurrent glioblastoma.

The authorisation follows Ariceum’s submission of a Clinical Trial Authorisation (CTA) application to the MHRA in December 2023 with the Phase 1 study expected to commence in the UK in June 2024. Ariceum is the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma, an aggressive form of brain cancer.

Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: “It is a tremendous achievement for Ariceum to receive CTA approval by the MHRA so soon after submission. Glioblastoma is the most common and most aggressive type of malignant brain tumour in adults, with a very poor prognosis for survival and currently no cure. Following the integration of Theragnostics into Ariceum and promising pre-clinical results, we welcome the opportunity to be the first company to trial Auger therapy for this indication and we plan to explore other solid tumour indications in the future.”

Dr Austin Smith, Medical Oncologist advising Ariceum Therapeutics, commented: “The CITADEL-123 study will allow us to demonstrate the safety and efficacy of ATT001 as a potential treatment option to address the high unmet medical need of patients with Glioblastoma. We are thankful for the continued collaboration with the team at UCLH, led by Dr Paul Mulholland and the support of the patient advocacy group, Braintrust – the brain cancer people.”

ATT001 delivers its radioisotope payload, Iodine-123, in a highly targeted way to cancer cells expressing PARP, an enzyme they use to repair its 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 regular 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.

For further information, please contact:

Ariceum Therapeutics
Manfred Rüdiger, CEO
Email: info@ariceum-therapeutics.com

Optimum Strategic Communications
Charlotte Hepburne-Scott, Zoe Bolt, Elena Bates
Tel: +44 (0) 20 3882 9621
Email: ariceum@optimumcomms.com

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.

Berlin, Germany, 6 December 2023 – Ariceum Therapeutics, a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, is pleased to announcethe granting of US and Canadian patents covering its Gallium-68 (Ga-68) radiopharmaceutical production kit. The IP was developed by Theragnostics Ltd, which was acquired by Ariceum earlier this year.

The patents have been sub-licensed exclusively to Advance Accelerator Applications (AAA) and apply to the technology underpinning AAA’s Ga-68 HBED-PSMA-11 production kit, branded Locametz^®. To date, the production of Ga-68 radiopharmaceuticals has involved a multi-step approach, which limits the number of patient doses that can be produced at any one time. Theragnostics’ Ga-68 technology platform enables the production of multiple doses of Ga-68 HBED-PSMA-11 in a single vial, in one simple step.

Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics said: “We are pleased that this IP has been granted so soon after our recent acquisition of Theragnostics, highlighting our progress and commitment to developing a pipeline of targeted radiotherapy innovations. We are proud to be contributing with this IP to the success of PSMA diagnostics, specifically Locametz, which represents an alternative pathway for PMSA PET imaging of patients.”

Greg Mullen, Chief Operating Officer of Ariceum Therapeutics and co-inventor of the patent, added: “This technology simplifies the production of Ga-68 PSMA for the benefit of thousands of patients around the world, which is incredibly rewarding to see. The granting of these patents represents another important milestone towards meeting anticipated increased demand for PSMA PET imaging of patients, following the publication of recent positive data demonstrating the benefit of radioligand therapy in prostate cancer.”

The announcement of the new patents comes prior to Dr Greg Mullen, Chief Operating Officer of Ariceum Therapeutics, and Dr Germo Gericke, Chief Medical Officer of Ariceum, presenting at the upcoming 5^th Targeted Radiopharmaceuticals Summit Europe, being held in Berlin, Germany, from Dec 5-7. Presentation details below.

Presentation Title: Understanding radionuclide Auger therapy to examine its use and advantages
Speaker: Dr Greg Mullen, Chief Operating Officer of Ariceum Therapeutics
Date & Time: 7 December, 1.30pm CET

Presentation Title: Bench to bedside – How to design innovative radiopharmaceuticals for human use
Speaker: Dr Germo Gericke, Chief Medical Officer of Ariceum Therapeutics
Date & Time: 7 December, 4.00pm CET

ENDS

For further information, please contact:

Ariceum Therapeutics
Manfred Rüdiger, CEO
Email: info@ariceum-therapeutics.com

Optimum Strategic Communications
Stephen Adams, Charlotte Hepburne-Scott, Zoe Bolt, Elena Bates
Tel: +44 (0) 20 3882 9621
Email: ariceum@optimumcomms.com

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 (ATT-001), which is slated to enter the clinic in early 2024. ATT-001 was part of the acquisition of Theragnostics Ltd which was closed earlier in 2023.

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

• 95% of patients (36 of 38) treated with Ariceum’s radiopharmaceutical satoreotide achieved disease control in Phase I/II trial
• That included 21% of patients (8 of 38) who experienced tumour reduction
• The study, just published in the European Journal of Nuclear Medicine and Molecular Imaging, concluded the treatment “has an acceptable safety profile with a promising clinical response” in SSTR2+ NET patients

Berlin, Germany, 28^th September 2023 – Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, is pleased to announce the publication of positive results from a Phase I/II trial of its radiopharmaceutical ¹⁷⁷Lu-satoreotide tetraxetan(satoreotide) in patients with previously treated, progressive neuroendocrine tumours (NETs), in the European Journal of Nuclear Medicine and Molecular Imaging.

Satoreotide combines Ariceum’s proprietary peptide satoreotide – a first-in-class and best-in-class antagonist of the somatostatin receptor 2 (SSTR2) – with the radioactive isotope ‘payload’ ¹⁷⁷Lutetium. SSTR2 is a cell surface protein often overexpressed in certain cancers, including NETs and small cell lung cancer (SCLC).

The Phase I/II trial was initiated by Ipsen, and recently completed after Ariceum acquired satoreotide from Ipsen. This international study was conducted in 7 countries – Australia, Austria, Canada, Denmark, France, Switzerland, and the UK – and enrolled 40 patients with advanced, SSTR2-positive NETs. The primary tumours of the patients included progressive, grade 1 and 2 (≈60%) gastroenteropancreatic (GEP), and (a)typical lung NETs, paraganglioma, and pheochromocytoma. All patients had undergone several lines of treatment, including chemo- and/or radiotherapy (45%), before they were treated with ¹⁷⁷Lu-satoreotide. Most patients received three infusions of satoreotide, with the median cumulative radiation dose being 13.0 GBq.

Of the 38 patients for whom full results were obtained, 28 (73.7%) achieved stable disease, as determined eight weeks after the last infusion. A further 8 (21.1%) experienced a partial response (a reduction in tumour size) – giving a total Disease Control Rate (DCR) of 94.7%. 17 of the 40 patients (42.5%) experienced grade ≥3 treatment‑related adverse events, the most common being lymphopenia, thrombocytopenia, and neutropenia. Two patients developed myeloid neoplasms considered treatment-related by the investigator.

The authors of the study, titled “A phase I/II study of the safety and efficacy of [177Lu]Lu‑satoreotide tetraxetan in advanced somatostatin receptor‑positive neuroendocrine tumours”, concluded satoreotide “has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs”. They also discussed that the lower administered activity, 3 cycles of 4.5 GBq compared to 4 cycles of 7.4 GBq with ¹⁷⁷Lu-DOTATATE, may offer advantages regarding the treatment burden for patients, but also in terms of reduction of nuclear waste and direct radioisotope costs. A 5-year follow-up study is ongoing.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: “These exciting new data demonstrate the great potential of our targeted radiopharmaceutical, satoreotide, for treating patients with advanced neuroendocrine tumours. Not only did a high proportion of treated patients achieve stable disease or better, but they did so on a lower dose of radiation than the investigators initially thought was needed. These results will greatly assist Ariceum in further developing satoreotide for hard-to-treat neuroendocrine cancers such as small cell lung cancer.”

Further details on the study can be found on Clinical Trials, under identifier NCT05017662.

Citation:

Wild, D., Grønbæk, H., Navalkissoor, S. et al. A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours. Eur J Nucl Med Mol Imaging (2023). https://doi.org/10.1007/s00259-023-06383-1

ENDS

For further information, please contact:

Ariceum Therapeutics
Manfred Rüdiger, CEO
Email: info@ariceum-therapeutics.com

Optimum Strategic Communications
Stephen Adams, Charlotte Hepburne-Scott, Zoe Bolt, Elena Bates
Tel: +44 (0) 20 3882 9621
Email: ariceum@optimumcomms.com

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