ITM Isotopen Technologien München AG

Garching/Munich, 
Germany
http://www.itm.ag
  • Booth: 883

ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radiopharmaceuticals and radionuclides. Since its foundation in 2004, ITM and its subsidiaries have established the GMP manufacturing and a robust global supply network of a novel, first-in-class medical radionuclide and -generator platform for a new generation of targeted cancer diagnostics and therapies. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeting molecules and therapies in various stages of clinical development addressing a range of cancers such as neuroendocrine cancers or bone metastases. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology.


 Press Releases

  • ITM Isotopen Technologien München AG (ITM), a specialized group of radiopharmaceutical companies, announced today that it has received the Pharma Trend Award 2018 "Most Innovative Product" in the start-up category. An interdisciplinary jury of six pharma representatives evaluated the submissions from start-up companies in biotechnology, medical engineering and digital health industries. The 19th edition of the awards ceremony took place on September 18, 2018, in the Deutsches Museum (German Museum) in Munich. The “Best Pharmaceutical Companies in Germany” ranking was also announced at the event in conjunction with the Pharma Trend “Image and Innovation Award”.

    The ranking is based on the survey data collected by Pharma Trend, which has been conducting annual surveys among doctors in Germany in the Rx category (prescription drugs) since 2000. As of 2018, it now also surveys 900 doctors and pharmacists in the OTC (pharmacists) and orphan drugs (clinicians) categories. In addition, 600 patients were surveyed in the OTC category. The expansion of the Pharma Trend survey enables pharmaceutical companies to be evaluated by their most important stakeholders (doctors, pharmacists and patients) in Germany in terms of innovation and sustainability. The respondents assess the pharmaceutical companies with regard to the quality of their marketing and sales, the quality of their products and services, innovation, affordability, transparency,
    responsibility, ethical practices, management quality and business success.

    The criteria of patient benefit, innovation, efficient patient care and integration in the German statutory insurance scheme were particularly decisive for the jury in the assessment of the products and projects submitted for the start-ups category, in which ITM took part.

    Steffen Schuster, Chief Executive Officer of ITM, said, "We are delighted to receive the ‘Most Innovative Product’ award at Pharma Trend 2018. Winning first place highlights our successful work in the development and preparation of a new generation of targeted cancer diagnostics and treatments. Targeted Radionuclide Therapy is increasingly seen as a promising treatment option for cancer and has already been used successfully for many years under compassionate use. We are confident that our lead candidate Solucin® for the treatment of neuroendocrine tumors, which is currently in phase III clinical trial, will be able to confirm these excellent results and will obtain approval as one of the world’s first therapeutic radiopharmaceuticals. With our Targeted Radionuclide Therapy, we want to make a significant contribution to improve outcomes and quality of life for cancer patients.”

                                                                                   – End –

    About ITM
    ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of novel, first-in-class medical radionuclides and generator platform for a new generation of targeted cancer diagnostics and therapies. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development, which address a range of cancers such as neuroendocrine cancers or bone metastases. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology.
    For more information about ITM, please visit: www.itm.ag

     

    Contact:
    Nicola Scharrer
    Head of Marketing
    Phone: +49 89 3298986-16
    Email: Nicola.Scharrer(at)itm.ag

    Media Contact: WE Communications
    Sebastian Klein
    Senior Account Executive
    Phone: +49 89 628175-46
    Email: ITM_AG(at)we-worldwide.com
     

    ITM Isotopen Technologien München AG
    Chairman of the Supervisory Board - Udo J. Vetter, Executive Board - Steffen Schuster (Chairman), Thomas Dürre
    Registered Office of the Company - Lichtenbergstr. 1, 85748 Garching – Commercial Register Munich - HRB 154944

  • The companies to combine their technologies to develop novel theranostic radiopharmaceuticals.

    Merck to supply folate derivatives for the preparation of folate-based radiotheranostics.

    ITM to receive option for worldwide exclusive license for clinical development and commercialization of folate-based radiotheranostics.
     

    Isotopen Technologien München AG (ITM), a group of specialized radiopharmaceutical companies, announced today that it has signed a Research Evaluation and Option Agreement for a worldwide exclusive license with Merck, Darmstadt, Germany. Merck is a global leader for the development and manufacturing of active pharmaceutical ingredients with particular expertise related to reduced folates. This partnership with Merck will allow for a broader application of ITM´s Theranostics platform to include diagnosis and therapy of patients with folate receptor-positive cancers.

    The partnership covers the evaluation of Merck first-in-class folate derivatives as radiolabeled diagnostic and therapeutic agents for the treatment of serious oncological folate receptor-positive diseases. Under the agreement ITM receives an option for a worldwide exclusive license for clinical development and commercialization of radiolabeled folate derivatives, while Merck will supply folate precursors for radiolabeling.

    Folate receptors are known to be overexpressed by several cancer types, such as ovarian, lung, breast and other types of cancers. The restricted expression of folate receptors to only a few sites in normal tissues makes them an attractive diagnostic and therapeutic target. Folate is a B vitamin that is critical to DNA synthesis as well as other essential cell processes. Folate derivatives retain their receptor binding properties when conjugated to pharmaceuticals. They have been proven to be promising compounds for cancer treatment for quite some time and therefore represent an outstanding addition to ITM´s Targeted Radionuclide Therapy pipeline.

    In folate receptor targeting, the folate moiety of the folate-based radiopharmaceutical acts as targeting molecule for both diagnosis and therapy. The radiopharmaceutical is injected into the patient´s body, where it binds to the corresponding receptors on the tumor tissue. The radio-conjugate is then absorbed by the tumor cells. For diagnostic application, medical radioisotopes with short half-lives, like Gallium-68, are combined with the targeting molecule. With highly sensitive molecular imaging technologies like PET (Positron Emission Tomography), whole-body diagnostic images are created. For targeted treatment, folate derivatives are complexed with medical radioisotopes with longer half-lives, like ITM´s highly pure no-carrier-added Lutetium-177. The availability of folate receptor-targeted radiopharmaceuticals for both diagnosis and therapy opens up the way for radiotheranostic applications in various indications.

    Dr Matthias Joehnck, Head of R&D Actives and Formulation, Merck, said: “The use of radiolabeled compounds for diagnosis or therapy in medicine is an intensively developing field. We are pleased that our technology will serve to advance a new and promising approach for cancer treatment.”

    “We are very delighted to have access to the outstanding technology and expertise of Merck in the area of pharmaceutical chemistry and manufacturing of folate-based compounds,” Steffen Schuster, Chief Executive Officer of ITM, added, “Merck has deep expertise in derivatization chemistry of Folic Acid and manufacturing of GMP grade folates. Their expertise, in combination with our innovative platform-technology, will help us to achieve new milestones in Targeted Radionuclide Therapy."

                                                                                         – Ends –


    About Targeted Radionuclide Therapy
    Targeted Radionuclide Therapy uses very small amounts of radioactive compounds, called radiopharmaceuticals, to diagnose and treat various diseases, like cancer. Targeted radiopharmaceuticals contain a targeting molecule (e.g. peptide or antibody) and a medical radioactive isotope. The technique works by injecting the radio-conjugate into the patient’s body where it accumulates in the affected organs or lesions. The targeting molecule binds to a tumor- specific receptor or antigen, according to a lock and key principle and is absorbed by the tumor cells. In most cases the targeting molecule can be used for both diagnosis and therapy – only the radioisotope has to be changed. This opens up the way for the application of Theranostics.

    For diagnostic applications radioisotopes with short half-lives are used. With highly sensitive molecular imaging technologies like PET (Positron Emission Tomography) or SPECT (Single Photon Emission Tomography), images of organs and lesions can be created and diseases can therefore be diagnosed in their early stages. Medical radioisotopes with longer half-lives are applied for treatment. The tumor tissue is being destroyed by the radiopharmaceutical emitting cytotoxic doses of ionizing radiation. A highly precise localization of the radioactivity ensures that healthy tissue in the surroundings of the targeted tumor is minimally affected.


    About ITM 
    ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of novel, first-in-class medical radionuclides and generator platform for a new generation of targeted cancer diagnostics and therapies. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development, which address a range of cancers such as neuroendocrine cancers or bone metastases. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology.
    For more information about ITM, please visit: www.itm.ag

    Contact:
    Nicola Scharrer
    Head of Marketing
    Phone: +49 89 3298986-16
    Email: Nicola.Scharrer(at)itm.ag

    Media Contact: WE Communications 
    Sebastian Klein
    Senior Account Executive
    Phone: +49 89 628175-46 
    Email: ITM_AG(at)we-worldwide.com

    ITM Isotopen Technologien München AG
    Chairman of the Supervisory Board - Udo J. Vetter, Executive Board - Steffen Schuster (Chairman), Thomas Dürre
    Registered Office of the Company - Lichtenbergstr. 1, 85748 Garching – Commercial Register Munich - HRB 154944

  • Houston (TX, USA) and Garching (Germany), July 26, 2018 – RadioMedix Inc. and ITM Isotopen Technologien München (ITM), a group of specialized radiopharmaceutical companies announced today that ITM’s subsidiary, Isotope Technologies Garching GmbH (ITG), and RadioMedix have signed a manufacturing and supply agreement for the production of the next generation of Ge-68/Ga-68 (Germanium-68/Gallium-68) generators at the new RadioMedix Spica Center (RSC) in Houston, Texas. RSC is a 21 CFR 211 compliant, radiopharmaceutical manufacturing facility dedicated to late stage investigational and commercial stage radiopharmaceuticals.

    The medical radionuclide Gallium-68, which is produced in Ge-68/Ga-68 generators, is used in the field of Targeted Radionuclide Therapy to diagnose cancers like prostate cancer and neuroendocrine tumors. When labeled to a disease-specific targeting molecule, the medical radioisotope can produce diagnostic images via positron emission tomography (PET), which maps the location of the specific cancer throughout the body.

    “RadioMedix has been the exclusive distributor of ITG products in North America since 2013, including their Ge-68/Ga-68 generators. With the opening of this state-of-the-art facility, our partnership will address the global supply shortage of Ga-68 generators. RadioMedix Spica Center has been selected as the manufacturing site for the newest generation of ITG generators and given the scale of this new facility, cannot only supply the needs of North America but potentially the global market. Ge-68/Ga-68 generators serve as an on demand source of a positron emitter that has recently revolutionized the R&D and clinical developments in the field of PET Radiopharmaceuticals,” said Dr Ebrahim S. Delpassand, Chairman and CEO of RadioMedix Inc. “The United States is one of the largest markets for these generators and a local manufacturing site as well as a DMF at the U.S. FDA for this product creates significant efficiencies in availability, cost, and distribution of this product in our country,” added Dr Delpassand.

    “We are delighted to expand our trusted partnership with RadioMedix for the production of our Ge-68/Ga-68 generators in the U.S.,” said Steffen Schuster, CEO of ITM. “Targeted Radionuclide Therapy is a unique theranostic approach and has been used increasingly in recent years due to its excellent efficacy with comparatively few side effects. To meet the medical community’s growing demand for radionuclides, we already partnered with a North American nuclear power company to achieve new scalability of the generators’ therapeutic companion, Lutetium-177. Our extended partnership with RadioMedix now gives us the opportunity to significantly improve our supply capabilities of our diagnostic radioisotope, Gallium-68. This cooperation is an important further step, as it helps us secure the supply of high-quality medical radioisotopes for Targeted Radionuclide Therapy to cancer patients worldwide.”

                                                                                                - Ends -


    RadioMedix Inc
    RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on development and manufacturing innovative targeted radiopharmaceuticals for the diagnosis, monitoring and therapy of cancer. The company is commercializing PET imaging and targeted radiotherapies using alpha- and beta-labeled drug products. RadioMedix has a strong clinical record serving as a sponsor and collaborator of multiple clinical trials. For more information visit us at www.radiomedix.com.

    RadioMedix Spica Center
    The RadioMedix SPICA Center (RSC) was established in early 2018, is a 27,000. SQF GMP manufacturing center, located near George Bush International airport, north of Houston, Texas. This state of the art, 21CFR 211 compliant, GMP manufacturing facility is focused on the production of the late stage investigational and commercial stage radiopharmaceuticals. RSC is equipped with 6 clean rooms, incorporating multiple lines of hot cells with fully automated synthesizers and processes. Q/C rooms are designed with the latest analytical instrumentation and modules. Our highly skilled and knowledgeable professionals have significant experience in FDA regulatory requirements for drug development and commercial manufacturing.

    ITM Isotopen Technologien München AG

    ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of novel, first-in-class medical radionuclides and generator platform for a new generation of targeted cancer diagnostics and therapies. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development, which address a range of cancers such as neuroendocrine cancers and bone metastases. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology. For more information about ITM, please visit: www.itm.ag


    RadioMedix Media Contact

    Susan Humphries
    Director of Public Awareness
    Phone: +1 713-358-6564
    Email: shumphries(at)radiomedix.com

    ITM Media Contact:

    Nicola Scharrer
    Head of Marketing
    Phone: +49 89 3298986-16
    Email: Nicola.Scharrer(at)itm.ag

  • Strategic Partnership supports Commercialization beyond ongoing Phase 3 VISION Trial of 177Lu-PSMA-617
     

    West Lafayette, IN, and Garching, Germany, July 09, 2018 – Endocyte, Inc. (Nasdaq:ECYT), and ITM Isotopen Technologien München AG (ITM), a group of specialized radiopharmaceutical companies, announced today that ITM´s subsidiary, Isotope Technologies Garching GmbH (ITG), and Endocyte have signed a long-term global supply agreement for the highly purified, no-carrier-added Lutetium-177 (177Lu) EndolucinBeta® to support clinical and commercial supply of 177Lu-PSMA-617, through 2035.

    “We are pleased to secure this long-term strategic partnership to ensure a reliable supply of no-carrier-added Lutetium-177 through commercialization,” said Mike Sherman, president and CEO of Endocyte. “This agreement broadens and extends the supply agreement with ITG that we established earlier this year, supporting our ongoing phase 3 VISION trial of 177Lu-PSMA-617 for the treatment of advanced prostate cancer.”

    Under the terms of the supply agreement, ITG will provide Endocyte with 100% of the Lutetium-177 required for the phase 3 VISION trial. ITG also will provide at least 50% and up to 100% of commercial supply at Endocyte’s request. Endocyte will pay €5 million up-front to support the company´s ongoing expansion of worldwide manufacturing capacity for Lutetium-177. Additional terms of the agreement are not disclosed.

    “We are pleased to extend our collaboration with Endocyte as a trusted partner while they develop this important potential therapy for patients with advanced prostate cancer,” said Steffen Schuster, CEO of ITM. “We believe ITM is already well positioned to support the completion of Endocyte’s VISION trial and we are preparing to support the potential global commercialization of this therapy. With multiple manufacturing facilities around the world and an unrivaled logistics network, we are confident we will reliably meet the needs for this significant opportunity.”

                                                                                       – Ends –

     


    About Endocyte
    Endocyte is a biopharmaceutical company and leader in developing targeted therapies for the personalized treatment of cancer. The company's drug conjugation technology targets therapeutics and companion imaging agents specifically to the site of diseased cells. Endocyte's lead program is a prostate specific membrane antigen (PSMA)-targeted radioligand therapy, 177Lu-PSMA-617, in phase 3 for metastatic castration-resistant prostate cancer (mCRPC). Endocyte also expects to have an Investigational New Drug application submitted in the fourth quarter of 2018 for its adaptor-controlled CAR T-cell therapy which will be studied initially in osteosarcoma. For additional information, please visit Endocyte's website at www.endocyte.com.

    Website Information
    Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the “Investors & News” section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the “Investors & News” section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.


    About ITM
    ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of novel, first-in-class medical radionuclides and generator platform for a new generation of targeted cancer diagnostics and therapies. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development, which address a range of cancers such as neuroendocrine cancers and bone metastases. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology. For more information about ITM, please visit: www.itm.ag


    Forward Looking Statements
    Certain of the statements made in this press release are forward looking, such as those, among others, relating to the Endocyte’s's future development plans including those relating to the completion of pre-clinical development in preparation for possible future clinical trials, the anticipated initiation of a registration trial, and preparation for potential commercialization. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company or independent investigators may experience delays in the initiation or completion of clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that data from prior clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company’s product candidates; risks that early stage pre-clinical data may not be indicative of subsequent data when expanded to additional pre-clinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair the company's ability to capture value for the technology; risks that expectations and estimates turn out to be incorrect, including estimates of the potential markets for the company’s product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, supply chain issues of any type, including timing of supply, projected cash needs, and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company’s periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


    Endocyte Investor Contact:

    Michael Schaffzin
    Stern Investor Relations, Inc.
    Phone: +1 (212) 362-1200
    Email: michael(at)sternir.com

    ITM Media Contact:
    Nicola Scharrer
    Head of Marketing
    Phone: +49 89 3298986-16
    Email: Nicola.Scharrer(at)itm.ag

  • Bruce Power to secure global supply of no-carrier-added Lutetium-177 through 2064.

    ITM to achieve new scalability of n.c.a Lutetium-177 (EndolucinBeta®)
     

    Tiverton, ON, Canada and Garching, Germany, July 06, 2018 - Bruce Power, a nuclear power company and source of medical radioisotopes, and ITM Isotopen Technologien München (ITM), a specialized radiopharmaceutical group of companies, announced today that ITM´s subsidiary, Isotope Technologies Garching (ITG), and Bruce Power have signed an agreement to explore the production of the medical radioisotope no-carrier-added (n.c.a.) Lutetium-177. Lutetium-177 is used in Targeted Radionuclide Therapy to treat cancers like neuroendocrine tumors and prostate cancer. It destroys cancer cells while leaving healthy cells unaffected.

    The two companies signed a Memorandum of Understanding to explore the production of n.c.a. Lutetium-177 at the Bruce Power Site. Bruce Power runs commercially operating reactors (CANDU reactors), that allow the company to meet global supply needs of Lutetium-177 through 2064. Furthermore, ITM has developed a unique methodology to produce a special form of Lutetium-177, n.c.a. Lutetium-177, which the company supplies globally under the brand name EndolucinBeta®. Because n.c.a. Lutetium-177 contains no metastable long-lived Lutetium-177m impurities, it provides the highest specific activity of all forms of the Lutetium-177 radioisotope. Its extraordinary level of radionuclidic purity ensures more effective and economical waste management, better environmental sustainability, and the best preconditions for the radiolabeling of biomolecules.

    This partnership aims to meet the medical community’s growing demand for radionuclides for use in Targeted Radionuclide Therapies. N.c.a. Lutetium-177 will be produced at Bruce Power’s CANDU reactors while development, processing, and global distribution of n.c.a. Lutetium-177 will be managed by ITM.

    “Bruce Power is a world leader in the production of critical radioisotopes used to treat cancer,” said Mike Rencheck, Bruce Power’s President and CEO. “By developing innovative ways to generate these radioisotopes, we help ensure that the medical community has access to a reliable source of medical radioisotopes for Targeted Radionuclide Therapy.”

    “We are looking forward to working with Bruce Power to secure a new global supply source and therefore achieve new scalability of our no-carrier-added Lutetium-177,” said Steffen Schuster, CEO of ITM. “With Bruce Power’s long-term capacity to operate its facilities through 2064 and its existing expertise with Cobalt production, we have the opportunity to provide a stable, high-quality source of Lutetium-177 to cancer patients worldwide.”

                                                                                       - Ends -

     
    About Bruce Power
    Formed in 2001, Bruce Power is an electricity company based in Bruce County, Ontario. We are powered by our people. Our 4,200 employees are the foundation of our accomplishments and are proud of the role they play in safely delivering clean, reliable, low-cost nuclear power to families and businesses across the province. Bruce Power is also a significant source of Cobalt-60, a radioisotope used for the sterilization of medical equipment around the world as well as a specialized form of cancer treatment called the Gamma Knife.

    Bruce Power is also part of the newly-established Canadian Nuclear Isotope Council (CNIC), which will ensure Canada remains a world leader in the production of life-saving radioisotopes by raising awareness and supporting long-term policies at the domestic and international level. Over 30 leading organizations from Canada and around the world have joined the council, which will develop collective solutions to maintain Canada’s leadership position on the global isotope stage. Learn more at www.brucepower.com and follow us on Facebook, Twitter, LinkedIn, Instagram and YouTube.


    About ITM
    ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of novel, first-in-class medical radionuclides and generator platform for a new generation of targeted cancer diagnostics and therapies. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development, which address a range of cancers such as neuroendocrine cancers and bone metastases. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology. For more information about ITM, please visit: www.itm.ag


    For further information, please contact:

    Bruce Power Duty Media:
    519-361-6161
    BNPDdutymedia(at)brucepower.com

    ITM Contact:
    Nicola Scharrer
    Head of Marketing
    Phone: +49 89 3298986-16
    Email: Nicola.Scharrer(at)itm.ag

    ITM Media Contact: WE Communications
    Sebastian Klein
    Senior Account Executive
    Phone: +49 89 628175-46
    Email: ITM_AG(at)we-worldwide.com

  • Recruitment in the U.S. for the COMPETE trial to begin shortly.

    Solucin® studied as a first-line therapy.

    Exclusively-produced nephroprotective amino acid solution administered.

    ITM Isotopen Technologien München AG (ITM), a specialized radiopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug Application (IND) to advance its innovative radiopharmaceutical Solucin® (n.c.a. 177Lu-Edotreotide), into a phase III clinical trial in the U.S..

    The COMPETE trial is led as an international, pivotal, multi-center, phase III clinical trial, evaluating the efficacy and safety of Targeted Radionuclide Therapy with Solucin® compared to Everolimus1 in patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The primary objective of the trial is to prolong progression-free survival (PFS) compared to Everolimus. COMPETE will be conducted predominantly in Europe, North America, South Africa and Australia. The company plans to start recruitment immediately at five designated sites in the U.S.: Excel Diagnostics & Nuclear Oncology Center, Mayo Clinic, Moffitt Cancer Center & Research Institute, University of Michigan Comprehensive Cancer Center, and Virginia Mason Medical Center.

    The study protocol of COMPETE was designed together with renowned neuroendocrine experts, including members of the European Neuroendocrine Tumor Society (ENETS). Accordingly, a broad indication was chosen with non-functional GE-NET / functional or nonfunctional P-NET. Everolimus, the current standard of care therapy, was chosen as the comparator for Targeted Radionuclide Therapy with Solucin®. The COMPETE clinical trial will also be the first to test Targeted Radionuclide Therapy as a first-line therapy against NET. The results of the trial could therefore influence the future treatment algorithm of NETs.

    In order to both maximize the therapeutic properties of Targeted Radionuclide Therapy and ensure that patients in the COMPETE study are exposed to as few side effects as possible, an amino acid solution consisting of arginine and lysine will be administered shortly before treatment. This amino acid solution has nephroprotective properties but is not yet commercially available. The Mayo Clinic, the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the Washington University School of Medicine in St. Louis, and the Memorial Sloan Kettering Cancer Center have jointly filed comments with the FDA recommending that regulatory changes be made to make arginine and lysine more easily available as bulk drug for patients who undergo Targeted Radionuclide Therapy.2

    “We are pleased to have received FDA acceptance for our clinical trial protocol and look forward to beginning recruitment for COMPETE in the U.S.”, said Steffen Schuster, Chief Executive Officer of ITM. “The commencement of this clinical trial in the U.S. marks a significant milestone for us. We are delighted to be able to collaborate with distinguished American experts in the fields of Targeted Radionuclide Therapy, Oncology, and Endocrinology to provide the best possible treatment for NET patients."

                                                                                            – Ends –


    Study Design
    The phase III clinical trial COMPETE is led as an international, prospective, randomized, controlled, open-label, multicenter phase III study to evaluate efficacy and safety of Targeted Radionuclide Therapy with n.c.a. 177Lu-Edotreotide (Solucin®) compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The trial, which is carried out in collaboration with the Clinical Research Organization ABX-CRO advanced pharmaceutical services GmbH, will be conducted worldwide in min. 12 countries and approx. 43 sites.

    In total, 300 GEP-NET patients will be randomized 2:1 to receive either Targeted Radionuclide Therapy with Solucin® consisting of a maximum of four cycles (7.5 GBq 177Lu-Edotreotide each), administered as i.v. infusion at 3-monthly intervals for 9 months, or until diagnosis of progression (200 patients), or 10 mg Everolimus daily, administered orally as a tablet until diagnosis of progression (100 patients). Study duration per patient will be 24 months.

    Primary objective is to demonstrate the efficacy of Targeted Radionuclide Therapy with 177Lu-Edotreotide to prolong progression-free survival (PFS) in patients with inoperable, progressive, SSTR+ GEP-NET, compared to Everolimus. Key secondary objectives are to show an increase in objective response rates (ORR), defined as the proportion of patients achieving partial response (PR) or complete response (CR) as best outcome, with 177Lu-Edotreotide compared to Everolimus and to assess overall survival (OS) defined as the time from date of randomization until death.


    About Targeted Radionuclide Therapy

    Targeted Radionuclide Therapy uses very small amounts of radioactive compounds, called radiopharmaceuticals, to diagnose and treat various diseases, like cancer. Targeted radiopharmaceuticals contain a targeting molecule (e.g. peptide or antibody) and a medical radioactive isotope. The technique works by injecting the radio-conjugate into the patient’s body where it accumulates in the affected organs or lesions. The targeting molecule binds to a tumor-specific receptor or antigen, according to a lock and key principle and is absorbed by the tumor cells. In most cases the targeting molecule can be used for both diagnosis and therapy – only the radioisotope has to be changed. This opens up the way for the application of Theranostics.

    For diagnostic applications radioisotopes with short half-lives are used. With highly sensitive molecular imaging technologies like PET (Positron Emission Tomography) or SPECT (Single Photon Emission Tomography), images of organs and lesions can be created and diseases can therefore be diagnosed in their early stages. Medical radioisotopes with longer half-lives are applied for treatment. The tumor tissue is being destroyed by the radiopharmaceutical emitting cytotoxic doses of ionizing radiation. A highly precise localization of the radioactivity ensures that healthy tissue in the surroundings of the targeted tumor is minimally affected.


    About Solucin®
    Solucin® (n.c.a. 177Lu-Edotreotide / n.c.a. 177Lu-DOTATOC) is known as an innovative Targeted Radionuclide Therapy agent with favorable safety profile and promising efficacy. Solucin® consists of two molecular components – Edotreotide (DOTATOC), an octreotide-derived somatostatin analogue, and EndolucinBeta® (no-carrier-added Lutetium-177) a synthetic, low-energy beta-emitting isotope of Lutetium.

    The targeting molecule Edotreotide (DOTATOC) contains DOTA, which functions as a chelator for radioisotopes and TOC, a synthetic somatostatin receptor ligand. It binds with high affinity somatostatin receptors (subtype 2 and 5) and retains both its receptor binding properties and its physiological function when labeled with 177Lu. Somatostatin receptors type 2 (SSTR2) are predominantly overexpressed by neuroendocrine tumors. Solucin®, upon binding to SSTR2 receptors in vivo, is internalized and retained by tumor cells. Upon decay, the isotope emits cytotoxic medium-energy beta particles of 1.7 mm path length in soft tissue.

    The radioactive isotope EndolucinBeta® respectively n.c.a. 177Lu chloride is used in Targeted Radionuclide Therapy, e.g. in the field of Precision Oncology. It is a radiopharmaceutical precursor, used for radiolabeling of disease-specific carrier molecules. EndolucinBeta® has a half-life of 6.647 days and provides the highest specific activity of more than 3,000 GBq/mg at Activity Reference Time (ART), and the day of ART can be flexibly selected by the customer. EndolucinBeta® exhibits an extraordinary level of radionuclidic purity. It does not contain metastable 177mLu, thus, there is no need of logistics and storage of contaminated radioactive waste. EndolucinBeta® is GMP certified and received marketing authorization in the EU in 2016.


    About ITM
    ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of novel, first-in-class medical radionuclides and generator platform for a new generation of targeted cancer diagnostics and therapies. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development, which address a range of cancers such as neuroendocrine cancers or bone metastases. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology.
    For more information about ITM, please visit: www.itm.ag


    References
    1)  Afinitor [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2018.
    2)  http://www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=29116

    Contact
    Nicola Scharrer
    Head of Marketing
    Phone: +49 89 3298986-16
    Email: Nicola.Scharrer(at)itm.ag

    Media Contact: WE Communications
    Stephanie Kunz
    Account Director
    Phone: +49 89 628175-19 
    Email: ITM_AG(at)we-worldwide.com

    ITM Isotopen Technologien München AG
    Chairman of the Supervisory Board - Udo J. Vetter, Executive Board - Steffen Schuster (Chairman), Thomas Dürre
    Registered Office of the Company - Lichtenbergstr. 1, 85748 Garching – Commercial Register Munich - HRB 154944


 Products

  • EndolucinBeta® (n.c.a. 177Lu chloride)
    Radiopharmaceutical precursor
    Indicated for radiolabeling of disease-specific carrier molecules
    Half-life: 6.647 days
    Specific activity: >3,000 GBq/mg at Activity Reference Time (ART)
    No metastable 177mLu...

  • EndolucinBeta 40 GBq/mL radiopharmaceutical precursor, solution

    Active substance: no-carrier-added (n.c.a.) Lutetium-177 (177Lu) chloride

    EndolucinBeta® is a radiopharmaceutical precursor and it is indicated for the radiolabeling of disease-specific carrier molecules in nuclear medicine. These biomolecules have been specifically developed for the radiolabeling with this radionuclide. The emerging radio conjugate is applied in Targeted Radionuclide Therapy, frequently in cancer treatment e.g. for neuroendocrine tumors (NETs). EndolucinBeta® has a half-life of 6.647 days and provides the specific activity of more than 3,000 GBq/mg at Activity Reference Time (ART). EndolucinBeta® contains no metastable 177mLu.

  • iQS-Theranostics Synthesizer
    A multipurpose automated cassette-based module for the preparation of 68Ga, 177Lu and 90Y radiolabeled biomolecules....

  • iQS-TS is a multipurpose automated cassette-based Theranostics Synthesizer facilitating the routine preparation of 68Ga, 177Lu and 90Y radiolabeled biomolecules. 

    The computer run iQS-TS system offers predefined labeling protocols for the manufacturing of a wide range of radiotracers such as PSMA and Somatostatin analogs hence ensuring reproducibility and full GMP compliant process documentation. User-friendly click‘n‘start cassettes and radiolabeling KITs with color-coded vials further facilitate an error-free handling of iQS-TS and consequently safe precious time in daily routine. 

    Prior to every synthesis iQS-TS performs an automated pre-run machine test to guarantee the functionality of the entire system. Also, at the end of every synthesis an included filter integrity test is realized to assure the sterility of the final product. The automated simple operation of iQS-TS makes the module especially favorable for production of radiopharmaceuticals. Due to iQS-TS‘s extremely small footprint and its perfect hygienic design iQS-TS suits easily in every hotcell and cleanroom environment.

    Safe time and obtain highest labeling yields in 17 min (68Ga) and 30 min (177Lu).

  • iQS® Ga-68 Fluidic Labeling Module
    Most compact and self-shielded synthesis module for convenient radiolabeling of biomolecules...

  • iQS® Ga-68 Fluidic Labeling Module is the most compact and easily portable system for convenient preparation of 68Ga labeled PET/CT tracers. 

    iQS® is the only self-shielded labeling module available on the market. Radiation protection is provided by a compact lead-shielding design and a smart integration of the fluidic system. Hence a safe routine use for the personnel is guaranteed and no cost expensive hot cell is required. 

    Obtain highest yield in an extremely short time: The time from elution of the generator to final product is down to only 15 minutes and the labeling yield amounts more than 80 percent. For the reduction of the 68Ge breakthrough a post-synthesis purification with a C18 cartridge is included.

    The combination of iQS® with the GMP 68Ga Radiolabeling KIT and the pre-assembled sterilized cassette entails independence and the convenience to receive all necessary and complementary materials from only one reliable supplier.

  • Quality Control Solution
    Fully integrated HPLC system for research and clinical routine in radiotracer- and radiopharmaceutical analytics....

  • Our ITG Quality Control Solution is the only fully integrated Radio-HPLC system (High-Performance Liquid Chromatography) which was specifically designed for the assessment of radiopharmaceuticals, thereby setting industry standards in terms of functionality and usability (in accordance with Ph. Eur. Standards). 

    This compact-standalone system offers many unique features that are essential for the ease of operation and data collection/processing in analytical radiochemistry. The shielded column chamber along with the column oven not only minimizes radiation exposure of personnel to an all-time low it is also dedicated for quality control of radiolabeled peptides according to Ph. Eur..

    The integration of high-quality HPLC components into our system such as a quaternary HPLC-pump (with active back flushing of the pistons), UV detector, γ-spec S 3700, online degasser and the latest Chromstarworkstation 7.0 software (Half-life corrections during or after the run) led to a compact one tower system with no hassle of external extra parts.

  • 68Ge / 68Ga Generator
    Metal free GMP certified 68Ge / 68Ga Generator for fast and convenient onsite
    production of 68Ga for radiolabeling....

  • 68Ga PET imaging has proven to be a superior method for precise localization of tumor cells and metastatic lesions. With the GMP certification of our 68Ge / 68Ga Generator we have set yet another milestone in order to establish 68Ga as next generation radioisotope for diagnostic purposes.
    The generator columns unique metal free design and its low acidic eluent allow the fast and convenient onsite production of short-lived high-quality 68Ga for radiolabeling without prior prepurification.

    Promotion only allowed for countries, in which the generator has Marketing Authorization or is not considered as a medical product.

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