A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants who Have Been Previously Treated with 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study

Start Date26 Jan 2022

Sponsor / Collaborator

Ariceum Therapeutics GmbHStartup

NCT04997317 / RecruitingEarly Phase 1IIT

Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-Satoreotide (PROMENADE-Study)

Meningiomas are known to be the most frequent intracranial neoplasms and account for approx. 25-33% of all intracranial tumours.Targeted radionuclide therapy with radiolabelled somatostatin analogues, also called Peptide Receptor Radionuclide Therapy (PRRT), has proven to be an effective treatment in metastatic intestinal neuroendocrine tumours and is currently used in advanced, recurrent or progressive meningiomas with promising results. In this study, the therapeutic index of a standard and newly developed radiolabelled somatostatin antagonist will be evaluated and compared in PRRT. In a second step, safety and efficacy of the latter will be assessed.

Start Date21 Apr 2021

Sponsor / Collaborator

Universitätsspital Basel

[+1]

NCT03773133 / TerminatedPhase 1/2

A Multicentre, Open-Label Phase I/II Study to Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)

This study consists of two phases. The phase I study is designed to investigate the safety and tolerability of Satoreotide tetraxetan following fractionated i.v. administrations in pre-treated subjects with locally advanced or metastatic cancers expressing sstr2 as identified by Satoreotide trizoxetan Positron Emission Tomography (PET/CT) scans. This phase will encompass both radioactivity escalation and peptide mass dose evaluation. Phase II will assess the efficacy of Satoreotide tetraxetan in subjects in selected indications, in a basket design.

Start Date14 May 2019

Sponsor / Collaborator

Ipsen SA

100 Clinical Results associated with 177Lu-Satoreotide tetraxetan

100 Translational Medicine associated with 177Lu-Satoreotide tetraxetan

100 Patents (Medical) associated with 177Lu-Satoreotide tetraxetan

Literatures (Medical) associated with 177Lu-Satoreotide tetraxetan

03 Jun 2024·MOLECULAR PHARMACEUTICS

Albumin-Binding Lutetium-177-Labeled LLP2A Derivatives as Theranostics for Melanoma

Article

Author: Ho, Khanh-Van ; Li, Longbo ; Iweha, Ejike ; Pun, Michael D ; Gallazzi, Fabio ; Watkinson, Lisa ; Anderson, Carolyn J ; Carmack, Terry L

Very late antigen-4 (VLA-4) is a transmembrane integrin protein that is highly expressed in aggressive forms of metastatic melanoma. A small-molecule peptidomimetic, LLP2A, was found to have a low pM affinity binding to VLA-4. Because LLP2A itself does not inhibit cancer cell proliferation and survival, it is an ideal candidate for the imaging and delivery of therapeutic payloads. An analog of [¹⁷⁷Lu]Lu-labeled-LLP2A was previously investigated as a therapeutic agent in melanoma tumor-bearing mice, resulting in only a modest improvement in tumor growth inhibition, likely due to rapid clearance of the agent from the tumor. To improve the pharmacokinetic profile, DOTAGA-PEG₄-LLP2A with a 4-(p-iodophenyl)butyric acid (pIBA) albumin binding moiety was synthesized. We demonstrate the feasibility of this albumin binding strategy by comparing in vitro cell binding assays and in vivo biodistribution performance of [¹⁷⁷Lu]Lu-DOTAGA-PEG4-LLP2A ([¹⁷⁷Lu]Lu-1) to the albumin binding [¹⁷⁷Lu]Lu-DOTAGA-pIBA-PEG₄-LLP2A ([¹⁷⁷Lu]Lu-2). In vitro cell binding assay results for [¹⁷⁷Lu]Lu-1 and [¹⁷⁷Lu]Lu-2 showed K_d values of 0.40 ± 0.07 and 1.75 ± 0.40 nM, with similar B_max values of 200 ± 6 and 315 ± 15 fmol/mg, respectively. In vivo biodistribution data for both tracers exhibited specific uptake in the tumor, spleen, thymus, and bone due to endogenous expression of VLA-4. Compound [¹⁷⁷Lu]Lu-2 exhibited a much longer blood circulation time compared to [¹⁷⁷Lu]Lu-1. The tumor uptake for [¹⁷⁷Lu]Lu-1 was highest at 1 h (∼15%ID/g) and that for [¹⁷⁷Lu]Lu-2 was highest at 4 h (∼23%ID/g). Significant clearance of [¹⁷⁷Lu]Lu-1 from the tumor occurs at 24 h (<5%ID/g) while[¹⁷⁷Lu]Lu-2 is retained for greater than 96 h (∼10%ID/g). An efficacy study showed that melanoma tumor-bearing mice receiving compound [¹⁷⁷Lu]Lu-2 given in two fractions (2 × 14.8 MBq, 14 days apart) had a greater median survival time than mice administered a single 29.6 MBq dose of compound [¹⁷⁷Lu]Lu-1, while a single 29.6 MBq dose of [¹⁷⁷Lu]Lu-2 imparted hematopoietic toxicity. The in vitro and in vivo data show addition of pIBA to [¹⁷⁷Lu]Lu-DOTAGA-PEG₄-LLP2A slows blood clearance for a higher tumor uptake, and there is potential of [¹⁷⁷Lu]Lu-2 as a theranostic in fractionated administered doses.

01 Dec 2023·European journal of nuclear medicine and molecular imaging

A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours

Article

Author: Navalkissoor, Shaunak ; Pennestri, Daniele ; Haug, Alexander ; Ansquer, Catherine ; Hicks, Rodney J ; Lenzo, Nat P ; Volteau, Magali ; Nicolas, Guillaume P ; Lassmann, Michael ; Grønbæk, Henning ; Wild, Damian ; Pais, Ben ; McEwan, Alexander ; Beauregard, Jean-Mathieu

Abstract:

Purpose:

We present the results of an open-label, phase I/II study evaluating the safety and efficacy of the novel somatostatin receptor (SSTR) antagonist [177Lu]Lu-satoreotide tetraxetan in 40 patients with previously treated, progressive neuroendocrine tumours (NETs), in which dosimetry was used to guide maximum administered activity.

Methods:

This study was conducted in two parts. Part A consisted of 15 patients who completed three cycles of [177Lu]Lu-satoreotide tetraxetan at a fixed administered activity and peptide amount per cycle (4.5 GBq/300 µg). Part B, which included 25 patients who received one to five cycles of [177Lu]Lu-satoreotide tetraxetan, evaluated different administered activities (4.5 or 6.0 GBq/cycle) and peptide amounts (300, 700, or 1300 μg/cycle), limited to a cumulative absorbed radiation dose of 23 Gy to the kidneys and 1.5 Gy to the bone marrow.

Results:

Median cumulative administered activity of [177Lu]Lu-satoreotide tetraxetan was 13.0 GBq over three cycles (13.1 GBq in part A and 12.9 GBq in part B). Overall, 17 (42.5%) patients experienced grade ≥ 3 treatment‑related adverse events; the most common were lymphopenia, thrombocytopenia, and neutropenia. No grade 3/4 nephrotoxicity was observed. Two patients developed myeloid neoplasms considered treatment related by the investigator. Disease control rate for part A and part B was 94.7% (95% confidence interval [CI]: 82.3–99.4), and overall response rate was 21.1% (95% CI: 9.6–37.3).

Conclusion:

[177Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three cycles, has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs. A 5-year long-term follow-up study is ongoing.

Trial registration:

ClinicalTrials.gov, NCT02592707. Registered October 30, 2015.

30 Jun 2023·EJNMMI radiopharmacy and chemistry

First preclinical evaluation of [²²⁵Ac]Ac-DOTA-JR11 and comparison with [¹⁷⁷Lu]Lu-DOTA-JR11, alpha versus beta radionuclide therapy of NETs.

Article

Author: Beekman, Savanne ; Bruchertseifer, Frank ; Denkova, Antonia ; de Ridder, Corrina ; Handula, Maryana ; Morgenstern, Alfred ; Konijnenberg, Mark ; de Blois, Erik ; Seimbille, Yann ; Stuurman, Debra

BACKGROUND:

The [¹⁷⁷Lu]Lu-DOTA-TATE mediated peptide receptor radionuclide therapy (PRRT) of neuroendocrine tumors (NETs) is sometimes leading to treatment resistance and disease recurrence. An interesting alternative could be the somatostatin antagonist, [¹⁷⁷Lu]Lu-DOTA-JR11, that demonstrated better biodistribution profile and higher tumor uptake than [¹⁷⁷Lu]Lu-DOTA-TATE. Furthermore, treatment with alpha emitters showed improvement of the therapeutic index of PRRT due to the high LET offered by the alpha particles compared to beta emitters. Therefore, [²²⁵Ac]Ac-DOTA-JR11 can be a potential candidate to improve the treatment of NETs (Graphical abstract). DOTA-JR11 was radiolabeled with [²²⁵Ac]Ac(NO₃)₃ and [¹⁷⁷Lu]LuCl₃. Stability studies were performed in phosphate buffered saline (PBS) and mouse serum. In vitro competitive binding assay has been carried out in U2OS-SSTR2 + cells for ^natLa-DOTA-JR11, ^natLu-DOTA-JR11 and DOTA-JR11. Ex vivo biodistribution studies were performed in mice inoculated with H69 cells at 4, 24, 48 and 72 h after injection of [²²⁵Ac]Ac-DOTA-JR11. A blocking group was included to verify uptake specificity. Dosimetry of selected organs was determined for [²²⁵Ac]Ac-DOTA-JR11 and [¹⁷⁷Lu]Lu-DOTA-JR11.

RESULTS:

[²²⁵Ac]Ac-DOTA-JR11 has been successfully prepared and obtained in high radiochemical yield (RCY; 95%) and radiochemical purity (RCP; 94%). [²²⁵Ac]Ac-DOTA-JR11 showed reasonably good stability in PBS (77% intact radiopeptide at 24 h after incubation) and in mouse serum (~ 81% intact radiopeptide 24 h after incubation). [¹⁷⁷Lu]Lu-DOTA-JR11 demonstrated excellent stability in both media (> 93%) up to 24 h post incubation. Competitive binding assay revealed that complexation of DOTA-JR11 with ^natLa and ^natLu did not affect its binding affinity to SSTR2. Similar biodistribution profiles were observed for both radiopeptides, however, higher uptake was noticed in the kidneys, liver and bone for [²²⁵Ac]Ac-DOTA-JR11 than [¹⁷⁷Lu]Lu-DOTA-JR11.

CONCLUSION:

[²²⁵Ac]Ac-DOTA-JR11 showed a higher absorbed dose in the kidneys compared to [¹⁷⁷Lu]Lu-DOTA-JR11, which may limit further studies with this radiopeptide. However, several strategies can be explored to reduce nephrotoxicity and offer opportunities for future clinical investigations with [²²⁵Ac]Ac-DOTA-JR11.

News (Medical) associated with 177Lu-Satoreotide tetraxetan

22 Oct 2024

·pipelinereview.com

Ariceum Therapeutics Presents Outstanding Data on its First-in-Class Radiopharmaceutical Drug 225Ac-Satoreotide at the European Association of Nuclear Medicine 2024

BERLIN, Germany I October 22, 2024 I 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 ‘ 225 Ac-SSO110 induces long-lasting anti-tumour responses in contrast to 225 Ac-DOTA-TATE and 161 Tb-DOTA-TATE in the treatment of SSTR2-positive tumour xenografts’ , details the anti-tumour efficacy of different radiolabelled satoreotide antagonists ( 225 Ac, 161 Tb, 177 Lu-labelled SSO110) versus respective DOTA-TATE agonists ( 225 Ac- and 161 Tb-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 225 Ac-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, 225 Ac-satoreotide, is multiple times more potent than SSTR2 agonist, 225 Ac-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 212 Pb 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 225 Ac-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: 225 Ac-SSO110 induces long-lasting anti-tumour responses in contrast to 225 Ac-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, 177 Lu-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 www.ariceum-therapeutics.com . 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

Phase 1AcquisitionOligonucleotide

22 Oct 2024

·www.prnewswire.com

Ariceum Therapeutics Presents Outstanding Data on its First-in-Class Radiopharmaceutical Drug 225Ac-Satoreotide at the European Association of Nuclear Medicine 2024

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

AcquisitionOligonucleotidePhase 1

07 Oct 2024

·www.pharmaceutical-technology.com

Health Canada approves Telix’s Illuccix label expansion

Illuccix is used for PET imaging to detect PSMA-positive lesions in male prostate cancer patients. Credit: Korawat photo shoot/Shutterstock. Health Canada has expanded the approved use of Telix Pharmaceuticals’ Illuccix for patient selection in prostate-specific membrane antigen (PSMA) targeted radionuclide therapy. This label expansion allows Illuccix, a gallium Ga 68 gozetotide injection kit, to be used for identifying progressive metastatic castration-resistant prostate cancer (mCRPC) patients eligible for lutetium (177Lu) vipivotide tetraxetan treatment, also known as Pluvicto. Since October 2022, Illuccix has been authorised in Canada for staging and re-staging intermediate and high-risk prostate cancer and pinpointing tumour tissue in recurrent cases. The latest approval enhances the clinical applications of Illuccix, which is distributed by Isologic Innovative Radiopharmaceuticals, reaching 265 hospitals and clinics across the country. Telix Precision Medicine CEO Kevin Richardson stated: “We welcome Health Canada’s decision to expand the label for Illuccix. This will further improve access to advanced prostate cancer imaging and provide doctors with critical information to help make treatment decisions with confidence. See Also: NUHS’s CD7 CAR-T cell therapy shows promise for leukaemia Editas trades part of Vertex CRISPR therapy licencing rights deal for $57m “This reflects Telix’s ongoing commitment to supporting patients with cancer and empowering the doctors who care for them across more stages of the patient journey.” Illuccix, post radiolabelling with gallium (68Ga), is indicated for positron emission tomography (PET) imaging of PSMA-positive lesions in men with prostate cancer. The indications include cases with suspected metastasis who are candidates for initial definitive therapy, suspected recurrence based on elevated serum prostate specific antigen (PSA) levels, and now, for identifying mCRPC patients for whom PSMA-targeted therapy is indicated. Isologic president André Gagnon stated: “PSMA-targeted theranostics are widely considered to be the future of prostate cancer treatment. It is therefore tremendous that we can now offer Illuccix in this additional setting, for patients who are candidates for PSMA-targeted therapy, through our national network.” In February 2024, Telix reached an agreement to buy US-based speciality radiopharmaceutical development and bioconjugation company IsoTherapeutics.

Cell TherapyDrug ApprovalImmunotherapyAcquisition

100 Deals associated with 177Lu-Satoreotide tetraxetan

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 2	US	Ipsen SA	14 May 2019
Breast Cancer	Phase 2	AT	Ipsen SA	14 May 2019
Breast Cancer	Phase 2	BE	Ipsen SA	14 May 2019
Breast Cancer	Phase 2	FR	Ipsen SA	14 May 2019
Breast Cancer	Phase 2	DE	Ipsen SA	14 May 2019
Breast Cancer	Phase 2	CH	Ipsen SA	14 May 2019
Breast Cancer	Phase 2	GB	Ipsen SA	14 May 2019
Small Cell Lung Cancer	Phase 2	US	Ipsen SA	14 May 2019
Small Cell Lung Cancer	Phase 2	AT	Ipsen SA	14 May 2019
Small Cell Lung Cancer	Phase 2	BE	Ipsen SA	14 May 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02592707 (Pubmed)	Phase 1/2	Neuroendocrine Tumors	40	[<sup>177</sup>Lu]Lu-satoreotide tetraxetan	lyjpqthele(pzhkdrxfrr) = nqzkozuebt wfykhnysgd (kldzneomkz ) View more	-	26 Mar 2024
NCT02592707 (phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan, CTgov)	Phase 1/2	Somatostatin Receptor-Positive Neuroendocrine Tumor	40	177Lu-IPN01072 (Part A: 177Lu-IPN01072 4.5 GBq)	ywnkfjfjui(rurozhuzvc) = usbfvbyxcs xkmodcqkjz (bedsrdhntv, zttdegadpl - nszqnxvhba) View more	-	19 Jul 2023
	Phase 1/2	Somatostatin Receptor-Positive Neuroendocrine Tumor	40	GBq+177Lu-IPN01072 (Part B Cohort 1: 177Lu-IPN01072 6 GBq)	ywnkfjfjui(rurozhuzvc) = wtdcarvcvg xkmodcqkjz (bedsrdhntv, qiehadwunz - tkuzwevrfz) View more	-	19 Jul 2023
NCT02592707 (ESMO2020) Manual	Phase 1/2	Neuroendocrine Tumors	35	177Lu-satoreotide tetraxetan	aqziqjkizy(dtklpoosei) = 34.3%[lymphopenia/decrease in lymphocyte counts in 6 (17.1%), thrombocytopenia/decrease in platelets count in 5 (14.3%), neutropenia in 2 (5.7%) and anemia in 1 (2.9%)]. No grade 3/4 renal toxicities were reported. udbugauzlq (qdrcjvifiu )	Positive	20 Sep 2020
SNMMI2016	Not Applicable	-	-	DOTA-JR11 (N.C.A 177Lu)	omqomekypa(scqiopdjwy) = eanhtkpxvf mbxnojtwmu (veoruwpsco )	-	24 May 2016
SNMMI2016	Not Applicable	-	-	DOTA-JR11 (177Lu/177mLu)	omqomekypa(scqiopdjwy) = jnrdjpltkg mbxnojtwmu (veoruwpsco )	-	24 May 2016

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