Renejix CDMO Partner for Small Molecule Oral Dosage Forms Renejix CDMO Partner for Small Molecule Oral Dosage Forms

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[{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Telix Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM Enters Global Supply Agreements with Telix Pharmaceuticals for Clinical and Commercial Use of ITM\u2019s n.c.a. Lutetium-177","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Clovis Oncology","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Clovis Oncology and ITM Announce Lutetium-177 Clinical Supply Agreement","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITM Introduces Second Phase III Trial, COMPOSE, with n.c.a. 177Lu-edotreotide for Neuroendocrine Tumors at NANETS Annual Symposium 2021","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"ANSTO","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM and ANSTO Announce Extension of Licensing Agreement for the Production and Supply of the Medical Radioisotope n.c.a. Lutetium-177","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITM Presents Study Design of COMPOSE Phase III Trial with ITM-11 (n.c.a. 177Lu-edotreotide) for Treatment of Neuroendocrine Tumors at ASCO-GI","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Grand Pharmaceutical Group Limited","pharmaFlowCategory":"D","amount":"$588.4 million","upfrontCash":"Undisclosed","newsHeadline":"ITM Receives Equity Investment of EUR 25 Million from Strategic Partner Grand Pharma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Grand Pharmaceutical Group Limited","pharmaFlowCategory":"D","amount":"$588.4 million","upfrontCash":"Undisclosed","newsHeadline":"ITM and Grand Pharma Enter into a Commercialization Agreement for Targeted Radiopharmaceuticals in the Greater China Area","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITM Presents Design of Second Phase III Trial, COMPOSE, with Radiopharmaceutical ITM-11 for the Treatment of Neuroendocrine Tumors at Annual ENETS Conference 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Indigenous Critical Infrastructure Fund Canada","pharmaFlowCategory":"D","amount":"$36.3 million","upfrontCash":"Undisclosed","newsHeadline":"ITM Receives EUR 33 Million Equity Investment to Advance Precision Oncology Pipeline of Targeted Radiopharmaceuticals","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITM Provides n.c.a. Lutetium-177 as Long-Term Supplier for Recently Approved Novel Radiotherapeutic in Metastatic Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITM to Host Symposium on Actinium-225 Targeted Radionuclide Therapy and to Present Phase III COMPOSE Trial Design at the Theranostics World Congress","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Y-mAbs Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM Signs Clinical Supply Agreement with Y-mAbs for n.c.a. Lutetium-177","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITM to Present Trial Design of Ongoing Phase III COMPOSE Study in Advanced Neuroendocrine Tumors at ESMO 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"BAMF","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM and BAMF Health Enter Global Cooperation Agreement for Targeted Radiopharmaceuticals in U.S. Radiopharmacy and Clinic Network","therapeuticArea":"Oncology","highestDevelopmentStatus":"Discovery Platform","country":"GERMANY","productType":"Small molecule","productStatus":"Undisclosed","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Discovery Platform"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Helmholtz Zentrum M\u00fcnchen","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM Executes Option to In-license Targeted Radionuclide Therapy Candidate LuCaFab (ITM-31) for the Treatment of Malignant Brain Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITM Receives FDA Fast Track Designation for Radionuclide Therapy Candidate ITM-11 (n.c.a. 177Lu-edotreotide) in Neuroendocrine Tumors (GEP-NETs)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"University Hospital Muenster","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITM, Helmholtz Munich and University Hospital M\u00fcnster Announce Start of Phase I Clinical Trial with Radiotherapeutic ITM-31 for Glioblastoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Paul Scherrer Institute","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM Enters Cooperation Agreement with Paul Scherrer Institute (PSI) for Co-Development and Upscaled Manufacturing of Terbium-161 for Theranostic Application in Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Temasek","pharmaFlowCategory":"D","amount":"$272.7 million","upfrontCash":"Undisclosed","newsHeadline":"ITM Announces \u20ac255m Investment Round, Plans to Advance Radiopharmaceutical Pipeline and to Expand Radioisotope Production Capacities","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Point Biopharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM and POINT Biopharma Expand Global Supply Agreement for n.c.a. Lutetium-177","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Merck Group","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM Executes License Agreement to Obtain Worldwide Exclusive License for the Clinical Development and Commercialization of Folate-Based Radiotheranostics","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Alpha-9 Oncology","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM and Alpha-9 Oncology Announce Global Supply Agreement to Support Alpha-9's Clinical Radiopharmaceutical Development Program","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Helmholtz Zentrum M\u00fcnchen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITM, Helmholtz Munich and University Hospital M\u00fcnster Announce First Patient Dosed in Phase I Investigator-Initiated Glioblastoma Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Isotope Technologies Munich","sponsor":"Temasek","pharmaFlowCategory":"D","amount":"$204.0 million","upfrontCash":"Undisclosed","newsHeadline":"ITM Raises \u20ac188M to Enhance Radiopharmaceutical Pipeline and Strengthen Position","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"June 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]

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            The proceeds will be used to prepare commercial readiness for the potential market launch of the company’s phase III lead candidate, ITM-11 (177Lu-edotreotide) for the treatment of GEP-NETs.

            Lead Product(s): Lutetium-177-edotreotide

            Therapeutic Area: Oncology Product Name: ITM-11

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Temasek

            Deal Size: $204.0 million Upfront Cash: Undisclosed

            Deal Type: Financing June 06, 2024

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            ITM-31 is a carbonic anhydrase (CA) XII-specific antibody Fab fragment, which is currently being evaluated for the treatment of glioblastoma.

            Lead Product(s): Lu-177 labeled 6A10-Fab-fragments

            Therapeutic Area: Oncology Product Name: ITM-31

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Helmholtz Zentrum München

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 23, 2024

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            Through collaboration, ITM will supply its medical radioisotope, non-carrier-added Lutetium-177 (n.c.a. 177Lu) for Alpha-9's Lutetium-based candidates for the treatment of cancer.

            Lead Product(s): Undisclosed

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Alpha-9 Oncology

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration January 30, 2024

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            Under the agreement, Merck will supply ITM with its first-in-class folate precursors for radiolabeling, which ITM will use to advance the clinical and potential future commercial development of its folate receptor-targeting radiopharmaceutical pipeline, including ITM-52.

            Lead Product(s): ITM-52

            Therapeutic Area: Oncology Product Name: ITM-52

            Highest Development Status: Preclinical Product Type: Small molecule

            Recipient: Merck Group

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement December 14, 2023

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            The expanded agreement broadens the supply of ITM’s n.c.a. 177Lu to POINT to enable its usage in the clinical and potential future commercial development of the 177Lu-based molecules in POINT’s development pipeline, including 177Lu-PNT2002 for prostate cancer.

            Lead Product(s): 177Lu-PNT2002

            Therapeutic Area: Oncology Product Name: PNT2002

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Point Biopharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 31, 2023

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            Details:

            The net financing will support the development of ITM’s broad Targeted Radionuclide Therapies oncology pipeline and enhance phase III clinical development for its lead pipeline candidate, ITM-11 (n.c.a. 177Lu-edotreotide) in gastroenteropancreatic neuroendocrine tumors.

            Lead Product(s): n.c.a. 177Lu-Edotreotide,Everolimus

            Therapeutic Area: Oncology Product Name: ITM-11

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Temasek

            Deal Size: $272.7 million Upfront Cash: Undisclosed

            Deal Type: Financing June 05, 2023

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            Under the agreement, the partners will combine their respective technologies and expertise in the production of terbium-161 including clinical and commercial use in Targeted Radionuclide Therapy (TRT) for the treatment of cancer.

            Lead Product(s): Terbium-161

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Paul Scherrer Institute

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement April 27, 2023

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            Details:

            ITM-31 targets a specific protein (antigen) called CA XII, which is highly expressed on the cell surface of glioblastoma cells and destroys them while sparing the healthy tissues. It comprises a CA XII antibody Fab fragment coupled with the radioisotope 177Lu.

            Lead Product(s): ITM-31

            Therapeutic Area: Oncology Product Name: ITM-31

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: University Hospital Muenster

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 13, 2023

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            Details:

            ITM-11 consists of two components: the medical radioisotope non-carrier-added lutetium-177 (n.c.a. 177Lu) and the targeting molecule edotreotide, a synthetic form of the peptide hormone somatostatin that targets neuroendocrine tumor-specific receptors.

            Lead Product(s): Lutetium-177-edotreotide

            Therapeutic Area: Oncology Product Name: ITM-11

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 27, 2022

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            Under the terms of the license agreement, ITM will hold exclusive rights to the compound ITM-31 as well as the rights to related patents and know-how for the manufacturing and use of ITM-31.

            Lead Product(s): ITM-31

            Therapeutic Area: Oncology Product Name: ITM-31

            Highest Development Status: Preclinical Product Type: Small molecule

            Recipient: Helmholtz Zentrum München

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement October 19, 2022

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