RYZ-101

225Ac-Satoreotide is a first-in-class somatostatin receptor 2 antagonist targeting extensive stage small cell lung cancer and is the first antagonist labelled with 225Ac to enter clinical development Satoreotide expressed a superior pharmacokinetic profile relative to DOTA-TATE with a higher pre-clinical anti-tumour efficacy, irrespective of radionuclide used 100% survival with a single dose of 30 kBq 225Ac-satoreotide but not with 225Ac-DOTA-TATE BERLIN, Oct. 22, 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 presented data on its proprietary radiolabelled peptide SS0110 (satoreotide), a first-in-class antagonist of the somatostatin receptor 2 (SSTR2), at this year's European Association of Nuclear Medicine (EANM) Annual Conference, held in Hamburg, Germany from 19-23 October 2024. The Top-Rated Oral Presentation (TROP) entitled '225Ac-SSO110 induces long-lasting anti-tumour responses in contrast to 225Ac-DOTA-TATE and 161Tb-DOTA-TATE in the treatment of SSTR2-positive tumour xenografts', details the anti-tumour efficacy of different radiolabelled satoreotide antagonists (225Ac, 161Tb, 177Lu-labelled SSO110) versus respective DOTA-TATE agonists (225Ac- and 161Tb-labelled DOTA-TATE) in mice engrafted with SSTR2 positive xenografts of small cell lung cancer (SCLC) and pancreatic cancer using clinically relevant associated dose ranges. Results demonstrate that 225Ac-satoreotide shows the strongest anti-tumoural effect in vivo at a low single dose when evaluating satoreotide and DOTA-TATE radiolabelled with different radionuclides. Irrespective of the radionuclides used, satoreotide demonstrated a higher pre-clinical anti-tumour efficacy when compared to DOTA-TATE which was less potent and required increased dose levels. Satoreotide was well tolerated across all dose levels and with all used radionuclides. These comparisons between satoreotide and DOTA-TATE will facilitate and guide further clinical development of satoreotide across multiple indications expressing SSTR2, such as SCLC, pancreatic cancers and Merkel Cell Carcinoma (MCC). Previous comparisons between satoreotide and DOTA-TATE demonstrated that antagonist, 225Ac-satoreotide, is multiple times more potent than SSTR2 agonist, 225Ac-DOTA-TATE, signifying a durable complete response in standard murine xenograft models of SCLC in animal models, versus tumour growth delay. Ariceum had previously shown at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting 2024 that 212Pb was not seen to be more potent than Lutetium or Terbium but caused more side effects and hence was not further pursued. Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "These results provide strong evidence for satoreotide and its potential to clinically outperform SSTR2 targeting agonists, by demonstrating significantly better efficacy in tumour growth control, up to complete tumour eradication depending on isotope used. In addition, when a single dose of 30 kBq 225Ac-satoreotide was administered, we observed high frequency of complete durable responses and 100% survival which strongly supports further clinical development for the treatment of SCLC, MCC and other cancers." Details of the oral presentation are as follow: Title: 225Ac-SSO110 induces long-lasting anti-tumour responses in contrast to 225Ac-DOTA-TATE and 161Tb-DOTA-TATE in the treatment of SSTR2-positive tumour xenografts Presenting Author: Prachi Desai, Scientist at Ariceum Therapeutics Session Number: 1204 Session Title: M2M Track - TROP Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation Oral Presentation Date & Time: Tuesday 22 October 2024, 09:00 AM – 09:10 AM CEST Abstract Authors: Prachi Desai, Manuel Sturzbecher-Hoehne, Dennis Mewis, Manfred Ruediger & Anika Jaekel of Ariceum Therapeutics Session Date & Time: Tuesday 22 October 2024, 08:00 AM – 09:30 AM CEST Location: Session Hall X1-X4 Abstracts are available in the September edition of Springer's European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) abstract book here and on the Ariceum website here. 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 (MCC), 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), currently in Phase 1 clinical development under the trial name CITADEL-123. 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 . About European Association of Nuclear Medicine (EANM) The European Association of Nuclear Medicine (EANM) is a non-profit organization that promotes nuclear medicine and aims to improve public health. The EANM's mission is to advance nuclear medicine through personalized healthcare, innovation in diagnosis and treatment, and raising awareness of nuclear medicine SOURCE Ariceum Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Radiopharmaceutical manufacturer PanTera has drawn a $102.5 million Series A investment round, the largest ever for a life sciences start-up in Belgium. Just two years into its existence, radioisotope producer PanTera has drawn 93 million euros ($102.5 million) in an oversubscribed Series A investment round, led by EQT Life Sciences.It is the largest Series A round ever for a Belgian company in the life sciences sector, according to EQT, and is evidence of the booming interest in radiopharmaceuticals for their ability to precisely target cancer cells. While there are many small-scale producers of radioisotopes, PanTera has established its niche by developing a patented production method that allows it to potentially become a large-scale producer of actinium-225 (225-Ac), which is the key ingredient needed to manufacture targeted alpha therapies. The investment will largely support the construction of a new manufacturing facility in Belgium. The funding round also includes some debt and convertible loan funding, bringing its total to 134 million euros ($148 million).“PanTera is looking to radically improve supply in the short and long term,” PanTera CEO Sven Van den Berghe, said in a release. “The size of this raise is testament to our strategy, our unique assets and our capabilities. We are working alongside very experienced partners with a combined expertise and a network that goes well beyond 225-Ac production and encompasses all aspects of the radiopharmaceutical revolution.”One of those partners on the manufacturing side is Bill Gates-founded TerraPower Isotopes, which extracts 225-Ac from legacy nuclear material in the U.S.On the supply side, PanTera signed on seven months ago with Bayer to provide it with 225-Ac for clinical trials. It was PanTera’s first deal with a major drugmaker. In March, PanTera announced (PDF) another supply deal with an undisclosed company. As many companies are scaling up for clinical trials, demand for 225-Ac is swelling. In addition to developing its large-scale manufacturing capability, PanTera is already supplying 225-Ac through an alternative production method, the company said. Before starting its commercial production, PanTera expects to have secured agreements for more than 80% of its capacity.“It is clear to us that PanTera has the expertise, assets and strategy in place to address the critical actinium-225 supply shortage faced by the pharmaceutical industry today, as well as the significant increase in demand expected in the future,” Martijn Kleijwegt, a partner at EQT, said in the release.PanTera was established as a joint venture by particle accelerator technology specialist IBA and the Belgium government’s nuclear research center SCK CEN. In December of last year, Bristol Myers Squibb entered the radiopharma race with a $4.1 billion acquisition of RayzeBio, paying more than triple what the biotech secured during its IPO when it went public just three months previous. The draw for BMS was RayzeBio’s platform based on 225-Ac.Back in June, RayzeBio had to halt enrollment in a trial of its lead candidate, RYZ101, because of supply shortfalls for the radioisotope. In July, RayzeBio said that the trial's enrollment has resumed. Radiopharma trailblazer Novartis has had pancreatic cancer drug Lutathera on the market since 2018, with its follow-on Pluvicto arriving in 2022. Those were developed using the beta-emitting isotope lutetium-177, the predecessor of 225-Ac. Last week, Novartis revealed that it would bring its radiopharmaceutical production in-house and was building a production facility in California, its third such site in the US.The radiopharmaceutical market is expected to grow from $7 billion this year to $39 billion by 2032.