Ariceum Therapeutics to present new radioligand therapy data at American Association for Cancer Research (AACR) Annual Meeting 2024

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.

Ariceum Therapeutics announces opening of new state-of-the-art laboratory in Berlin providing infrastructure for radiopharmaceutical development activities

Berlin, Germany, 5 March 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 the opening of its new laboratory facilities on 7 March at its Berlin headquarters to house the research and development of its next generation radiopharmaceutical pipeline candidates and support the transfer of advancing products into the clinic.

With the new facility, Ariceum has more than ~200m² of laboratory space (cold biology/chemistry lab; radioactive lab) to which a further ~60m² of changing lock and storage space can be added. It provides Ariceum with the capability to work with positron emission tomography (PET) and single-photon emission computed tomography (SPECT) isotopes for imaging, and beta and alpha isotopes for therapy. The lab is equipped to enable Ariceum to carry out on-site process, method, validation and formulation development as well as preliminary stability analysis of its radiolabeled compounds. Furthermore, the new laboratory will allow Ariceum to conduct non-clinical pharmacology studies for detailed characterization of its first-in-class development candidates.

Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, said: “Following 15 months of construction at our headquarters in Berlin, we are delighted to have opened our brand new, advanced laboratory space.  Since our inception in 2021, Ariceum has significantly expanded the team and made important advances in the development of next-generation, targeted radiotherapeutics but we have had to use external radio pharma facilities to enable this. Our new laboratory will give us the internal capability not only to progress the development of our lead radiopharmaceutical candidates but to provide a state-of-the-art research hub to advance R&D collaborations and identify exciting new pipeline candidates. We are very grateful to our team in Berlin who have pushed hard to bring these construction plans to fruition.”

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.

Ariceum Therapeutics Granted UK Authorisation to Conduct Phase I Clinical Study of its First-in-Class Iodine-123 Labelled PARP Inhibitor in Patients with Recurrent Glioblastoma

Berlin, Germany, 29th 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.

Ariceum Therapeutics files for UK Clinical Trial Authorisation (CTA) to test its First-in-Class Iodine-123 labelled PARP inhibitor in patients with recurrent glioblastoma

Berlin, Germany, 10th January 2024 – Ariceum Therapeutics, a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announces it has submitted an application with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to undertake a Phase 1 trial of 123I-ATT001, its Iodine-123 labelled PARP inhibitor in patients with recurrent glioblastoma.

The application comes shortly after Ariceum acquired Theragnostics Ltd, announced in June 2023, the private UK-based biopharmaceutical company which undertook the initial development work on 123I-ATT001. 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 of Ariceum Therapeutics said: “Glioblastoma is the most aggressive and most common type of malignant brain tumour in adults, with a very poor prognosis for survival and currently no cure. 123I-ATT001 is a targeted Auger electron therapy that has demonstrated promising pre-clinical results, and we are delighted to be in a position to file for clinical trial authorisation in the UK so soon after integrating Theragnostics into Ariceum Therapeutics. Not only is this an important step towards finding a cure for glioblastoma patients but it paves the way for Ariceum to further investigate this powerful molecular radiotherapy for the treatment of other solid tumour indications.”

ATT001 delivers its radioisotope payload, Iodine-123, in a highly targeted way to cancer cells expressing PARP, an enzyme they use to repair themselves. This radioisotope then 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 is exploring 123I-ATT001 in other solid tumour indications, as PARP is a validated target, highly expressed in several other cancers.

The announcement comes as Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, is in San Francisco attending the Biotech Showcase from 8-10 January 2024. Please get in touch if you would like to arrange a meeting.

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 clinical development in 2024. ATT-001 was part of the acquisition of Theragnostics Ltd which was closed in June 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.

Ariceum Therapeutics announces granting of US and Canadian patents for its Gallium-68 radiopharmaceutical production kit

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 5th 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.

Ariceum Therapeutics Wins Deal of the Year (<€500M) Award at the LSX Leaders European Lifestars Awards

Ariceum Therapeutics was delighted to be presented with the Deal of the Year (<€500M) Award at this year’s LSX Leaders European Lifestars Awards for its strategic research collaboration with UCB! The agreement is to identify and develop novel systemic targeted radiopharmaceuticals for the treatment of solid tumors and immune-related diseases. Ariceum celebrated among a wealth of talented and innovative companies and individuals recognised for their contribution in many areas.

Ariceum’s Chief Executive Officer Manfred Rüdiger (right) celebrates with Chief Business Officer Serge Sagodira (left)

Ariceum Therapeutics’ targeted radiopharmaceutical 177Lu-satoreotide exhibits promising clinical response and good tolerability profile in patients with advanced neuroendocrine tumours

  • 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, 28th 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

Ariceum Therapeutics doses first patient with its first-in-class targeted radiopharmaceutical drug satoreotide in its Phase Ib study in small cell lung cancer

  • Ariceum develops satoreotide its first and best-in-class somatostatin receptor 2 antagonist in extensive stage small cell lung cancer
  • Phase Ib study design will be presented at the European Association of Nuclear Medicine Congress 2023 (EANM 2023) in Vienna, Austria on 10th September 2023

Berlin, Germany, 7th 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 that the first patient has been dosed with its first-in-class lead molecule, satoreotide, targeting extensive stage small cell lung cancer (ES-SCLC), at the GenesisCare Murdoch Theranostics and Molecular Imaging Centre in Perth, Australia.

Ariceum has successfully initiated its multicentre, open label Phase Ib study which will investigate the safety and tolerability of the ‘theranostic pair’ of somatostatin receptor antagonist 68Ga-Satoreotide Trizoxetan (SSO120) and 177Lu-satoreotide tetraxetan (SSO110) in patients with ES-SCLC. The main objective of the study is to establish a recommended Phase 2 dose and schedule.

‘Theranostics’ is the approach of using two paired drugs – the first, a diagnostic agent to identify cells which exhibit a particular biomarker; and the second, a therapeutic drug, to act on those cells. Both the diagnostic agent and therapeutic drug contain Ariceum’s proprietary peptide satoreotide, a first-in-class and best-in-class antagonist of the somatostatin receptor 2 (SST2), a cell surface protein often overexpressed in certain cancers including small cell lung cancer (SCLC).

The study, entitled LuSato-1 study, includes patients with ES-SCLC who will each receive an infusion containing the diagnostic imaging agent, somatostatin receptor antagonist before undergoing a positron emission tomography (PET) scan. This will determine if a patient’s tumours express the SST2. Patients identified with confirmed SST2 expression will receive escalating doses of satoreotide, in addition to the immunotherapy atezolizumab, a PD-L1 checkpoint inhibitor, during the maintenance phase of their treatment until a recommended phase 2 dose can be defined. Additional patients may be enrolled in an expansion cohort. Further details on the study can be found on Australian Clinical Trials, under identifier Ariceum SSO11O-01.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: “The initiation of this Phase Ib study is an important milestone reached by the Company in close collaboration with our partners in Australia and Europe. We believe that our lead targeted systemic radiopharmaceutical product satoreotide has the potential to demonstrate positive results in patients with extensive stage small cell lung cancer. Theranostics holds great hope as a highly targeted form of cancer therapy, using a ‘search and destroy’ approach to seek out tumours while sparing healthy tissue.”

Germo Gericke, Chief Medical Officer of Ariceum Therapeutics, said: “Although immune checkpoint blockade has improved the treatment of ES-SCLC, disease recurrence often occurs early in the maintenance phase. Adding targeted radiotherapy with satoreotide to immune checkpoint blockade in the maintenance setting holds the promise to improve the therapeutic effect of the maintenance therapy.”

An Abstract on the LuSato-1 study will be presented at the European Association of Nuclear Medicine Congress 2023 (EANM 2023) in Vienna, Austria, on 10th September 2023. Presentation details below.

Abstract OP-230
Top Rated Oral Presentations (TROP) Session: Oncology & Theranostics Committee
Session: 606 – Neuroendocrine Tumours Treatment
Abstract title: A phase I theranostic study evaluating the safety and tolerability of 177Lu-satoreotide tetraxetan with 68Ga-satoreotide trizoxetan companion imaging in participants with extensive-stage small-cell lung cancer (ES-SCLC) on atezolizumab maintenance therapy
Authors: L. Emmett, J. Cardaci, K. O’Byrne, S. Arulananda, A. Prawira, B. Pais, M. Crumbaker, N. Lenzo
Date & Time: 10 September, 4:45-6:15pm CEST

ENDS

For further information, please contact:

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

Optimum Strategic Communications
Hollie Vile, 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 (SST2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), 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

Ariceum Therapeutics and Eurofins CDMO Sign a Pharmaceutical Multi-Project Agreement

  • Eurofins CDMO to provide Clinical Trial Supply services to support Ariceum’s clinical trials  

Berlin, Germany, and Nantes, France, 26 June 2023 – Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, and Eurofins CDMO (part of Eurofins’ network of companies – Eurofins Scientific SE (EURONEXT PARIS: ERF)), a leading global Contract Development and Manufacturing Organization, today announce a strategic partnership which will see Eurofins CDMO provide Clinical Trial Supply services to support Ariceum’s current Phase I/II clinical studies in Australia, as well as future clinical studies.

Initial work on this strategic partnership began one year ago, and the past 12 months have seen the establishment of infrastructure required to support and supply Ariceum’s clinical trials. Services provided to Ariceum Therapeutics by Eurofins CDMO are facilitated in the Eurofins CDMO EUR site in Lentilly, France, which specializes in Clinical Trial Supply services, and comprise, among other services, Qualified Person (QP) release of Drug Substance into Europe, Storage of Drug Substance, Packaging Drug Product, Cold Chain Management (-20oC and 2/8oC) and the management of deliveries of Drug Product to investigational sites. Eurofins CDMO’s short internal process lead times provide Ariceum with the required flexibility to respond to project needs.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: “Ariceum is pleased to partner with renowned Eurofins CDMO for the supply of its studies. Over the past year Eurofins CDMO has proven to be a flexible and reliable partner. Through this partnership, Ariceum has established the infrastructure required to support and supply the recently initiated Phase I/II trials in Australia as well as future clinical trials.”

For further information, please contact:

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

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

Eurofins CDMO
Eleonore Galeazzi, Senior Director Business Development & Marketing Europe
Email: eleonoregaleazzi@eurofins.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 (SST2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), 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 and Switzerland and activities currently across Europe, North America and Australia.

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 Eurofins CDMO

Eurofins CDMO is a leading global Contract Development and Manufacturing Organization that provides clients with active pharmaceutical ingredients (“API’s”) / drug substance and drug product development for biologics and small molecules. Its service offering encompasses drug substance/API development, solid state research and development, pre-formulation, formulation and development, analytical development, Non-GMP & GMP manufacturing and clinical packaging and logistics. Operating with facilities in Europe, North America and India, Eurofins CDMO is accredited through the FDA, EMA, ANSM, ANSES, FAMHP, PMDA, and Health Canada.

To learn more: www.eurofins.com/cdmo.

Eurofins CDMO is part of the international network of Eurofins laboratories.

About Eurofins – the global leader in bio-analysis

Eurofins is Testing for Life. With over 61,000 staff across a network of 900 laboratories in 61 countries, Eurofins’ companies offer a portfolio of over 200,000 analytical methods.

Eurofins Shares are listed on Euronext Paris Stock Exchange.

 

Ariceum Therapeutics Expands Pipeline with Acquisition of Theragnostics Ltd

  • Acquisition of next generation radiopharmaceutical clinical pipeline to include Auger-based systemic targeted PARP inhibitor radiation therapies
  • Expansion of operations in the US
  • Acquisition of commercial FDA-approved, diagnostic product NEPHROSCANTM in partnership with GE Healthcare and Ga-68 kit technology IP currently licensed to Novartis
  • Theragnostics’ and Ariceum’s leadership teams to join forces creating a specialist team of experts in the field of Radiopharmaceuticals

Berlin, Germany, 1 June 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 acquisition of Theragnostics Ltd., a UK-based private biopharmaceutical company engaged in the development of radio-labelled PARP inhibitors for the diagnosis and treatment of tumours.

The acquisition provides Ariceum with an expanded portfolio of therapeutic and diagnostic assets in late preclinical and early clinical development. It also comprises NEPHROSCANTM, a diagnostic product in partnership with GE Healthcare which is approved by the US Food and Drug Administration (FDA) and affords Ariceum expanded operations in the US.

Under the terms of the acquisition, Ariceum will acquire 100% of the shares of Theragnostics in exchange for an upfront payment of $2.5 million in cash and milestone payments totalling up to $41.5 million.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: “We are delighted to welcome Theragnostics’ expert radiopharmaceutical team to Ariceum and to integrate its innovative products into our proprietary pipeline through this acquisition. In full alignment with our strategy, Ariceum continues to create value for its shareholders by building and advancing a well-balanced portfolio from early discovery to mid-clinical stage projects up to FDA approved NEPHROSCANTM which advances our presence in the US.”

Greg Mullen, Former Chief Executive Officer of Theragnostics and Newly Appointed Chief Operating Officer of Ariceum Therapeutics, commented: “The acquisition by Ariceum Therapeutics is an exciting opportunity for Theragnostics and we are delighted to be part of a world-leading and innovative radiopharmaceutical company, ensuring the rapid clinical development of PARP inhibitor Auger therapy.”

Theragnostics’ assets obtained by Ariceum include ATD 001 (formerly THG 008), a novel fluorine-18 radiolabelled PARP inhibitor for the imaging cancer, and AT-001 (formerly THG 009), a I-123-labelled PARP inhibitor which is in development for the treatment of aggressively growing cancers and already having UK ILAP approval for primary and recurrent glioblastoma. Theragnostics’ early non-clinical data have demonstrated promising results which support progression of AT-001 into a Phase 1 clinical study in recurrent glioblastoma. Auger emitters such as I-123 combined with a PARP inhibitor enable delivery of radionuclides to the DNA to selectively kill cancer cells whilst sparing healthy tissue, thereby offering a potentially powerful treatment option in several cancer indications.

In addition, Ariceum will gain access to the US FDA-approved product, NEPHROSCANTM (partnered with GE Healthcare), a radioactive diagnostic agent indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adults and paediatric patients. Ariceum will also acquire Theragnostics Ga-68 kit technology IP which is licensed by Theragnostics to Novartis for their approved Ga-68 PSMA kit, LOCAMETZ®, a diagnostic medicine used in adults with prostate cancer.

ENDS

For further information, please contact:

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

Optimum Strategic Communications
Hollie Vile, 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 has made 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 (SST2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), 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.

Following the acquisition of Theragnostics Ltd, Ariceum Therapeutics obtained all assets, including FDA-approved product, NEPHROSCANTM in partnership with GE Healthcare.

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, Australia and Switzerland and activities currently across Europe, North America and Australia.

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