A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).

The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to <18 years of age with somatostatin receptor (SSTR)-positive tumors.

Start Date01 Jun 2024

Sponsor / Collaborator

ITM Solucin GmbH

NCT05918302 / RecruitingPhase 3IIT

Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.

Start Date27 Oct 2023

Sponsor / Collaborator

Mfar Constructions Pvt Ltd.

[+1]

NCT06045260 / Not yet recruitingPhase 2

"Receptor Radionuclide Therapy With 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in SSTR Positive Patients: a Multicenter, Prospective, Phase II Trial"

Peptide receptor radionuclide therapy (PRRT) may be recommended in G1- G2 GEP-NET patients with disease progression on somatostatine analogues therapy (LUTATHERA®). However, there are several diseases, including neuroendocrine neoplasia not originating from the digestive tract, for which the efficacy of PRRT has already been demonstrated, but which are not currently within the indications of LUTATHERA and therefore cannot benefit from it (i.e. bronchopulmonary, ovarian, renal NETs and neuroendocrine carcinomas). Moreover, the role of PRRT is also accepted in Pheochromocytomas and paragangliomas (PPGLs), Meningiomas, but also as a salvage therapy in pre-treated NET pts, and other SSTR-positive malignancies (Lymphomas, Gliomas…). Least explored among radiopharmaceuticals for SSTR-positive tumors is 177Lu-DOTATOC. This study aims to investigate the efficacy and safety of lutetium (177Lu) edotreotide (Lu-Dotatoc) on all the above-mentioned diseases that could benefit from receptor radionuclide therapy. We believe that this study, which will involve only patients outside the indication of LUTATHERA, will expand the current knowledge of radionuclide receptor therapy with 177Lu- DOTATOC, particularly with regard to objective response and safety parameters, and may consolidate its in the management of these diseases.

Start Date01 Oct 2023

Sponsor / Collaborator

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori SRL

100 Clinical Results associated with Lutetium (177Lu) edotreotide

100 Translational Medicine associated with Lutetium (177Lu) edotreotide

100 Patents (Medical) associated with Lutetium (177Lu) edotreotide

Literatures (Medical) associated with Lutetium (177Lu) edotreotide

01 Jan 2024·Theranostics

Long-term Nephrotoxicity after PRRT: Myth or Reality

Article

Author: Yu, Fei ; Zhang, Jingjing ; Baum, Richard P ; Schuchardt, Christiane ; Fan, Xin ; Chen, Xiaoyuan ; Jakobsson, Vivianne

Rationale: The kidneys are commonly considered as the potential dose-limiting organ for peptide receptor radionuclide therapy (PRRT), making the risk of nephrotoxicity a primary concern. This retrospective analysis with prospective documentation and long-term follow-up aims to assess the risk of nephrotoxicity after PRRT in a large cohort of patients with neuroendocrine neoplasms (NENs) treated at our institution over the past 18 years. Methods: A total of 1361 NEN patients treated with 1-10 cycles of ¹⁷⁷Lu-DOTA-TOC/-NOC/-TATE, ⁹⁰Y-DOTA-TOC/-NOC/-TATE, DUO-PRRT (sequential administration of ⁹⁰Y- and ¹⁷⁷Lu-), or TANDEM-PRRT (combination of ⁹⁰Y- and ¹⁷⁷Lu- on the same day concomitantly) were included in this analysis. All parameters were prospectively documented in a structured database comprising over 250 items per patient and retrospectively analyzed. Kidney function, including serum creatinine, blood urea nitrogen, cGFR, and electrolytes, was evaluated before each PRRT cycle and during follow-up. Restaging was regularly performed at 6-month intervals until death. Treatment-related adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0). Results: Between 2000 and 2018, a total of 5409 cycles of PRRT were administered to 1361 NEN patients. Follow-up after complete treatment was available for 1281 patients receiving 4709 cycles of PRRT, with a median follow-up time of 69.2 months (interquartile range, 32.8-110.5 months) and a maximum follow-up time of 175 months. Baseline creatinine levels were normal in 1039/1281 (81.1%) subjects, while grade 1 (G1) renal insufficiency was present in 221/1281 (17.3%) prior to PRRT. G2 was present in 19/1281 (1.5%), and G3 in 2/1281 (0.2%). After treatment, the proportion of G3/G4 grade patients only increased from 0.2% to 0.7%. Mean creatinine levels increased from a baseline of 0.90 ± 0.30 to 1.01 ± 0.57 mg/L (80.0 ± 26.7 to 89.4 ± 50.8 μmol/L) after treatment. In our main analysis cohort of 1244 patients (4576 cycles), 200 patients experienced an increase in CTCAE creatinine grade. Age, number of treatment cycles, type of radionuclides, and length of follow-up time were the main factors affecting CTCAE creatinine grading after treatment. When comparing the subgroups treated with different radionuclides, the risk of nephrotoxicity after ⁹⁰Y treatment alone and the ⁹⁰Y/¹⁷⁷Lu combination group was higher than after ¹⁷⁷Lu treatment alone. In the ⁹⁰Y treatment subgroup, the two significant risk factors for an increased CTCAE creatinine grade were identified to be age (≥60) and a long follow-up time. Conclusions: This retrospective analysis with prospective documentation in a large cohort of 1281 NEN patients receiving 4709 cycles of PRRT co-administered with renal protection, treated through the individualized approach at a single institution over 18 years, did not reveal any evidence of long-term PRRT-related renal toxicity. The results of our study suggest that with the use of proper renal protection, nephrotoxicity due to PRRT is more likely a myth than a reality.

20 Jul 2023·Pharmaceutics

Improving Overall Survival and Quality of Life in Patients with Prostate Cancer and Neuroendocrine Tumors Using ¹⁷⁷Lu-iPSMA and ¹⁷⁷Lu-DOTATOC: Experience after 905 Treatment Doses.

Article

Author: Ferro-Flores, Guillermina ; García-Pérez, Osvaldo ; Santos-Cuevas, Clara ; Azorín-Vega, Erika ; Gibbens-Bandala, Brenda ; Rojas-Pérez, Melissa ; Hernández-Ramírez, Rodrigo ; Soto-Abundiz, Airam ; Ancira-Cortez, Alejandra ; Lara-Almazán, Nancy ; Ocampo-García, Blanca ; Luna-Gutiérrez, Myrna ; López-Buenrostro, Sergio ; Soldevilla-Gallardo, Irma

¹⁷⁷Lu-iPSMA is a novel radioligand developed at ININ-Mexico with a high affinity for the PSMA protein heavily expressed in cancer cells of approximately 95% of patients with metastatic castration-resistant prostate cancer (mCRPC). ¹⁷⁷Lu-DOTATOC is a patent-free radioligand, molecularly recognized by somatostatin receptors (SSTR-2) overexpressed in cancer cells of about 80% of patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NET). This translational research aimed to determine the efficacy and safety of ¹⁷⁷Lu-iPSMA and ¹⁷⁷Lu-DOTATOC developed as GMP pharmaceutical formulations for treating progressive and advanced mCRPC and NET. One hundred and forty-five patients with mCRPC and one hundred and eighty-seven subjects with progressive NET (83% GEP-NET and 17% other NET), treated with ¹⁷⁷Lu-iPSMA and ¹⁷⁷Lu-DOTATOC, respectively, were evaluated. Patients received a mean dose of 7.4 GBq per administration of ¹⁷⁷Lu-iPSMA (range 1-5 administrations; 394 treatment doses) or ¹⁷⁷Lu-DOTATOC (range 2-8 administrations; 511 treatment doses) at intervals of 1.5-2.5 months. Efficacy was assessed by SPECT/CT or PET/CT. Results were stratified by primary tumor origin and number of doses administered. Patients with mCRPC showed overall survival (OS) of 21.7 months with decreased radiotracer tumor uptake (SUV) and PSA level in 80% and 73% of patients, respectively. In addition, a significant reduction in pain (numerical scale from 10-7 to 3-1) was observed in 88% of patients with bone metastases between one and two weeks after the second injection. In the GEP-NET population, the median progression-free survival was 34.7 months, with an OS of >44.2 months. The treatments were well tolerated. Only ten patients experienced grade ≥ 3 myelosuppression (3% of all patients). The observed safety profiles and favorable therapeutic responses demonstrated the potential of ¹⁷⁷Lu-iPSMA and ¹⁷⁷Lu-DOTATOC to improve overall survival and quality of life in patients with progressive and advanced mCRPC and NET.

01 Jul 2023·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of ¹⁶¹Tb into the Clinic.

Article

Author: Landolt, Stefan ; van der Meulen, Nicholas P ; Grundler, Pascal V ; Talip, Zeynep ; Sepini, Lebogang ; Köster, Ulli ; Schibli, Roger ; Geistlich, Susanne ; Müller, Cristina ; Favaretto, Chiara

¹⁶¹Tb is an interesting radionuclide for application in the treatment of neuroendocrine neoplasms' small metastases and single cancer cells because of its conversion and Auger-electron emission. Tb has coordination chemistry similar to that of Lu; therefore, like ¹⁷⁷Lu, it can stably radiolabel DOTATOC, one of the leading peptides used for the treatment of neuroendocrine neoplasms. However, ¹⁶¹Tb is a recently developed radionuclide that has not yet been specified for clinical use. Therefore, the aim of the current work was to characterize and specify ¹⁶¹Tb and to develop a protocol for the synthesis and quality control of ¹⁶¹Tb-DOTATOC with a fully automated process conforming to good-manufacturing-practice guidelines, in view of its clinical use. Methods: ¹⁶¹Tb, produced by neutron irradiation of ¹⁶⁰Gd in high-flux reactors followed by radiochemical separation from its target material, was characterized regarding its radionuclidic purity, chemical purity, endotoxin level, and radiochemical purity (RCP) in analogy to what is described in the European Pharmacopoeia for no-carrier-added ¹⁷⁷Lu. In addition, ¹⁶¹Tb was introduced into a fully automated cassette-module synthesis to produce ¹⁶¹Tb-DOTATOC, as used for ¹⁷⁷Lu-DOTATOC. The quality and stability of the produced radiopharmaceutical in terms of identity, RCP, and ethanol and endotoxin content were assessed by means of high-performance liquid chromatography, gas chromatography, and an endotoxin test, respectively. Results: ¹⁶¹Tb produced under the described conditions showed, as the no-carrier-added ¹⁷⁷Lu, a pH of 1-2, radionuclidic purity and RCP of more than 99.9%, and an endotoxin level below the permitted range (175 IU/mL), indicating its appropriate quality for clinical use. In addition, an efficient and robust procedure for the automated production and quality control of ¹⁶¹Tb-DOTATOC with clinically applicable specifications and activity levels, that is, 1.0-7.4 GBq in 20 mL, was developed. The radiopharmaceutical's quality control was also developed using chromatographic methods, which confirmed the product's stability (RCP ≥ 95%) over 24 h. Conclusion: The current study demonstrated that ¹⁶¹Tb has appropriate features for clinical use. The developed synthesis protocol guarantees high yields and safe preparation of injectable ¹⁶¹Tb-DOTATOC. The investigated approach could be translated to other DOTA-derivatized peptides; thus, ¹⁶¹Tb could be successfully applied in clinical practice for radionuclide therapy.

News (Medical) associated with Lutetium (177Lu) edotreotide

07 Jun 2024

·www.pharmaceutical-technology.com

ITM gains $204.6m investment for radiopharmaceutical pipeline

The funding will support the commercial launch of the company’s Phase III lead candidate, ITM-11, for cancer. Credit: Lightspring / Shutterstock. ITM Isotope Technologies Munich (ITM) has secured an investment of €188m ($204.6m) aimed at bolstering its radiopharmaceutical pipeline. Recommended Buyer's Guides Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry Buyer's Guide Leading Guide to Clinical Packaging Companies in contract Manufacturing for the Pharmaceutical Industry Global investment company Temasek spearheaded the funding round with contributions from entities managed by BlackRock , the Qatar Investment Authority (QIA), ATHOS and Carbyne. The funding will be channelled towards advancing and broadening ITM’s radiopharmaceutical pipeline, supporting the development platform and commercially launching its Phase III lead candidate, ITM-11 (n.c.a. 177 Lu-edotreotide). The asset is currently under evaluation in two Phase III trials, COMPETE and COMPOSE, for the treatment of gastroenteropancreatic neuroendocrine tumours. The investment will enable ITM to bolster its manufacturing capabilities for Lutetium-177 ( 177 Lu) and expand its production to include other high-value medical radioisotopes such as Actinium-225 ( 225 Ac). See Also: FDA recommends updated Covid-19 vaccines targeting JN.1 India’s DCGI approves Orchid Pharma’s API Enmetazobactam As part of the expansion, the company will also supply the in-demand medical radioisotopes to its extensive global network and utilise them to diversify its radiopharmaceutical therapy pipeline. This strategy is designed to address a variety of challenging cancer indications. ITM CEO Steffen Schuster stated: “The additional equity and continued collaboration with our existing, industry-specialised investors emphasises their confidence in our ability to drive value for the radiopharmaceutical field through our unmatched manufacturing capabilities and innovative precision oncology pipeline. “We have reached key milestones since our last financing round including advancing our pipeline with novel targets in multiple oncology indications, opening our NOVA facility, launching Actineer with CNL for the joint production of Actinium-225 and entering several high-value supply agreements for Lutetium-177. “As we continue growing as an organisation, our focus remains on bringing the significant therapeutic benefits of radiopharmaceutical therapy to as many patients worldwide as possible and we are thankful for the additional financing which will support us on this path.”

VaccinePhase 3Phase 2

06 Jun 2024

·firstwordpharma.com

Key radioisotope supplier ITM raises over $200M to fund pipeline, boost manufacturing

As radiopharmaceuticals continue their hot streak, one of the few players with a marketed product, ITM Isotope Technologies Munich, has pulled in additional funding to help advance its lead pipeline candidate. The firm has secured a new investment of €188 million ($204 million), led by previous backer Temasek, with participation from BlackRock, Qatar Investment Authority and ATHOS.ITM currently markets EndolucinBeta, which uses lutetium-177 (177Lu) for radiolabelling of other medicines, and TOCscan/Sogacin, which uses gallium (68Ga) edotreotide for diagnosing neuroendocrine tumours (NETs). While the two products are sold in a handful of European countries, ITM's pipeline has loftier ambitions and is stacked with a number of targeted radionuclide therapies based not only on 177Lu and 68Ga, but also on actinium-225 (225Ac), fluorine-18 and terbium-161.Phase III nearing completionIts lead asset, ITM-11 (177Lu-edotreotide), is nearing the end of Phase III testing in gastroenteropancreatic NETs (GEP-NETs). The late-stage COMPETE study is evaluating ITM-11 in patients with Grade 1 - 2 GEP-NETs, while the COMPOSE trial is for patients with well-differentiated high Grade 2 - 3 GEP-NETs. With this in mind, ITM will use some of the proceeds from the latest financing to “prepare commercial readiness” of ITM-11.“We have reached key milestones since our last financing round including advancing our pipeline with novel targets in multiple oncology indications,” remarked CEO Steffen Schuster. Almost exactly a year ago to the day, ITM announced a haul of €255 million – again led by Temasek – building on the €58 million it raised in 2022 and €114 million it secured in the prior year. Key supplier to NovartisAside from its internal pipeline, ITM recently launched a joint venture to produce 225Ac, while it has several supply agreements in place for 177Lu, including with Telix Pharmaceuticals and Endocyte, the latter now part of Novartis. In fact, the Swiss drugmaker is one of the key players in the radiopharmaceutical space, with its marketed products including Lutathera (177Lu dotatate) for GEP-NETs and the prostate cancer therapy Pluvicto (177Lu vipivotide tetraxetan). However, Novartis itself has faced production issues for Pluvicto, and only recently gained clearance for a new US radioligand manufacturing facility to help it keep up with demand.ITM plans to put some of the new funding toward ramping up its in-house manufacturing capacities for 177Lu and expand these to new radioisotopes including 225Ac. ITM said it will use the radioisotopes not only for its own pipeline, but also provide them to its global supply network. For related analysis, see Vital Signs: Mapping the slim pickings in radiopharmaceuticals.

Phase 3OligonucleotideIND

06 Jun 2024

·www.biospace.com

ITM Raises €188m to Enhance Radiopharmaceutical Pipeline and to Strengthen Leading Position in Medical Radioisotope Manufacturing

Proceeds to support development of ITM’s targeted radiopharmaceutical pipeline and preparations for potential market launch of phase III lead candidate, ITM-11, as it nears clinical read-out Funds will also enable expansion of manufacturing capabilities for the production of alpha- and beta-emitting radioisotopes, including Lutetium-177 (177Lu) and Actinium-225 (225Ac) Garching / Munich, Germany, June 06, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced an equity investment of €188 million led by Temasek with participation from funds managed by BlackRock1, Qatar Investment Authority (QIA), ATHOS and Carbyne. The new capital will be used to advance and expand ITM’s innovative radiopharmaceutical pipeline, foster its leading development platform and prepare commercial readiness for the potential market launch of the company’s phase III lead candidate, ITM-11 (n.c.a. 177Lu-edotreotide) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Further solidifying its current position in radioisotope supply, ITM will also apply the new funds together with its expertise as the globally leading manufacturer of n.c.a. Lutetium-177 (177Lu) to increase its in-house manufacturing capacities for 177Lu and expand them to new, high-value medical radioisotopes including Actinium-225 (225Ac). The company will provide these sought-after medical radioisotopes to its global supply network and apply them to broaden its own Radiopharmaceutical Therapy (RPT) pipeline designed to address an array of hard-to-treat cancer indications. “ITM is an industry-leading expert in the manufacturing and supply of high-quality medical radioisotopes with a groundbreaking pipeline on the cusp of an exciting data inflection point,” said Udo J. Vetter, Chairman of the Supervisory Board at ITMand Chairman of the Advisory Board of Vetter Pharma. “This financing furthers our position as a driver and partner for the radiopharmaceutical industry by supporting commercial readiness efforts for ITM-11 and the expansion of our pipeline with new medical isotopes capable of addressing various cancer indications, all while increasing our robust manufacturing capacities.” “The additional equity and continued collaboration with our existing, industry-specialized investors emphasizes their confidence in our ability to drive value for the radiopharmaceutical field through our unmatched manufacturing capabilities and innovative precision oncology pipeline,” noted Steffen Schuster, CEO of ITM. “We have reached key milestones since our last financing round including advancing our pipeline with novel targets in multiple oncology indications, opening our NOVA facility, launching Actineer with CNL for the joint production of Actinium-225 and entering several high-value supply agreements for Lutetium-177. As we continue growing as an organization, our focus remains on bringing the significant therapeutic benefits of Radiopharmaceutical Therapy to as many patients worldwide as possible and we are thankful for the additional financing which will support us on this path.” ITM is built on longstanding experience in the production and supply of high-quality medical radioisotopes for the precise diagnosis and treatment of cancer with an established global supply network. As a fully vertically integrated radiopharmaceutical company, ITM is applying its in-house expertise to develop a broad pipeline of targeted radiopharmaceuticals designed to provide medical benefit for patients living with a range of hard-to-treat cancer indications. ITM-11 (n.c.a. 177Lu-edotreotide), the company’s lead candidate, is being evaluated for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in two phase III clinical trials, COMPETE for grade 1 and grade 2 GEP-NETs and COMPOSE for grade 2 and grade 3 GEP-NETs. ITM’s global leadership position in the manufacturing of radioisotopes is a critical value driver for its expanding pipeline programs and is also central to the global radiopharmaceutical industry overall. About Radiopharmaceutical Therapy (RPT) Radiopharmaceutical Therapy (RPT) is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope such as Lutetium-177 or Actinium-225 to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, such as receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, with the goal of destroying tumor tissue. The precise localization enables targeted treatment with potentially minimal impact to healthy surrounding tissue. About ITM Isotope Technologies Munich SE ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. About Temasek Temasek is a global investment company with a net portfolio value of S$382 billion (US$287b, €264b, £232b, RMB1.98t) as at 31 March 2023. Its Purpose “So Every Generation Prospers” guides it to make a difference for today’s and future generations. As an active investor, forward looking institution and trusted steward, it is committed to deliver sustainable value over the long term. Temasek has overall corporate credit ratings of Aaa/AAA by rating agencies Moody’s Investors Service and S&P Global Ratings respectively. Headquartered in Singapore, it has 13 offices in 9 countries around the world: Beijing, Hanoi, Mumbai, Shanghai, Shenzhen, and Singapore in Asia; and London, Brussels, Paris, New York, San Francisco, Washington DC, and Mexico City outside Asia. For more information on Temasek, please visit . About BlackRock BlackRock’s purpose is to help more and more people experience financial well-being. As a fiduciary to investors and a leading provider of financial technology, we help millions of people build savings that serve them throughout their lives by making investing easier and more affordable. For additional information on BlackRock, please visit . About QIA Qatar Investment Authority (“QIA”) is the sovereign wealth fund of the State of Qatar. QIA was founded in 2005 to invest and manage the state reserve funds. QIA is among the largest and most active sovereign wealth funds globally. QIA invests across a wide range of asset classes and regions as well as in partnership with leading institutions around the world to build a global and diversified investment portfolio with a long-term perspective that can deliver sustainable returns and contribute to the prosperity of the State of Qatar. For more information on QIA, visit its website at . About ATHOS ATHOS is a renowned single-family office committed to furthering cutting-edge technologies and building transformative companies, investing entrepreneurially and value based. About Carbyne Carbyne Equity Partners is a European private equity firm that invests in growing businesses with strong market positions and excellent leadership. Carbyne’s focus sectors are healthcare, nutrition and agricultural technology. The operational experience of the team combined with access to firsthand industry expertise and an extensive network to support expansions, makes Carbyne a unique partner. For more information on Carbyne, please see . ITM Contact Corporate Communications Kathleen Noonan / Julia Westermeir Phone: +49 89 329 8986 1502 Email: communications@itm-radiopharma.com Investor Relations Ben Orzelek Phone: +49 89 329 8986 1009 Email: investors@itm-radiopharma.com 1 BlackRock through its Private Equity Partners team Attachment 20240606_ITM Announcement_Financing_Temasek-led Investment

Phase 3Radiation Therapy

100 Deals associated with Lutetium (177Lu) edotreotide

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neuroendocrine neoplasm of lung	Phase 3	FR	ITM Isotopen Technologien München AG	27 Oct 2023
Neuroendocrine neoplasm of lung	Phase 3	IT	ITM Isotopen Technologien München AG	27 Oct 2023
Neuroendocrine neoplasm of lung	Phase 3	ES	ITM Isotopen Technologien München AG	27 Oct 2023
Thymus Neoplasms	Phase 3	FR	ITM Isotopen Technologien München AG	27 Oct 2023
Thymus Neoplasms	Phase 3	IT	ITM Isotopen Technologien München AG	27 Oct 2023
Thymus Neoplasms	Phase 3	ES	ITM Isotopen Technologien München AG	27 Oct 2023
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	US	ITM Solucin GmbH	02 Feb 2017
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	AU	ITM Solucin GmbH	02 Feb 2017
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	AT	ITM Solucin GmbH	02 Feb 2017
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	BE	ITM Solucin GmbH	02 Feb 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04194125 (ESMO2023) Manual	Phase 2	Neuroendocrine Tumors	21	177Lu DOTATOC+ CAPTEM	zltadcouxe(zweiyrescp) = ausasuwmxv qfnzgwumob (sfgmrymmyg, 16.0 - NR) View more	Positive	22 Oct 2023
				177Lu DOTATOC+ CAPTEM (panNET)	zltadcouxe(zweiyrescp) = dtdcsxusqk qfnzgwumob (sfgmrymmyg, 14.0 - NR)

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