Berlin, Germany – 13 September 2023 – Eckert & Ziegler (ISIN DE0005659700, TecDAX) today announced they have entered into a comprehensive collaboration agreement with RefleXion Medical, Inc. (RefleXion) and Telix Pharmaceuticals Limited (ASX:TLX, Telix) to jointly develop a new concept – Satellite Hot Labs (SHLs). SHLs are designed specifically for radiolabeling, quality control and storage of molecular targeting radiotracers, referred to as BioGuides, that are used in biology-guided radiotherapy (BgRT) to direct the radiation beam to indicated solid tumor cancers.
The development of the SHL will allow radiolabeling of cold kits including Gallium-68 PSMA-11 (gallium-68 gozetotide, Illuccix®) for use with RefleXion’s BgRT technology (SCINTIX® therapy). Ga-68 PSMA-11 is currently approved in nuclear medicine for the diagnosis of late-stage prostate cancer and for selection of patients for Lutetium-177 PSMA therapy.
The establishment of SHLs supports greater access for Ga-68 PSMA-11 to be used in the field of external-beam radiotherapy, that will offer a new treatment option for all prostate cancer stages. SHLs will enable greater flexibility for provision of radiotracers on-demand and in the shortest spatial distance to the linear accelerator, thus saving crucial resources.
“We are excited to be part of this unique project, which will transfer and expand the use of Gallium-68 into radiation therapy,” stated Dr. Harald Hasselmann, CEO of Eckert & Ziegler AG. “In addition to providing our extensive technological and regulatory expertise in the areas of radiosynthesis and quality control, this engagement offers great potential for our product GalliaPharm®.”
"This agreement strengthens Telix’s collaborations with Eckert & Ziegler and RefleXion, two companies with whom we have built very strong working relationships. The combination of Illuccix with RefleXion’s innovative SCINTIX therapeutic technology is another example of the potential for Gallium-68-based PSMA imaging technology to enhance the management and treatment of prostate cancer,” said Richard Valeix, Group Chief Commercial Officer of Telix.
"Our goal is to expand the patient population that can benefit from SCINTIX therapy to patients with prostate cancer through bringing Illuccix to market as a new BioGuide for SCINTIX,” said Thorsten Melcher, Ph.D., Chief Business Officer at RefleXion. “We are pleased to have two experienced partners at our side to jointly lead the SHL project to success.”
SCINTIX therapy is delivered through the RefleXion X1 platform, which combines positron emission tomography (PET) with a linear accelerator (LINAC) to deliver a radiation dose that tracks the cancer’s motion. Immediately prior to treatment, the patient is injected with a radiopharmaceutical that interacts with cancer cells to produce signals or emissions. The device continuously constructs a map from the detected emissions data that determines where to aim beamlets of radiation and destroy cancer tissue, including oligo- and polymetastases.
The RefleXion X1 with SCINTIX therapy is currently U.S. Food and Drug Administration (FDA) cleared for FDG-guided treatment of primary and metastatic tumors in the lung and bone only.
The GalliaPharm® 68Ge/68Ga radionuclide generator is GMP grade system continuously producing Gallium-68 by decay of its radioactive parent Germanium-68. Ga-68 from GalliaPharm® is currently mainly used for the preparation of diagnostic imaging drugs in Positron Emission Tomography (PET). The generator offers a cost-efficient alternative to cyclotron-produced diagnostic radioisotopes.
GalliaPharm® has been registered as a drug product in the European Union, Canada, and Brazil. A Type II Drug Master File (#28741) is available in the USA.
Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer (United States label):
- With suspected metastasis who are candidates for initial definitive therapy;
- With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level;
- For whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.
Illuccix has been approved by the FDA, by the Australian Therapeutic Goods Administration (TGA), and by Health Canada. Telix is also progressing Marketing Authorisation Applications for 68Ga-PSMA-11 in the United Kingdom and the European Union.
About Eckert & Ziegler
Eckert & Ziegler Strahlen- und Medizintechnik AG with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).
About RefleXion Medical
RefleXion is a privately held therapeutic oncology company located in Hayward, Calif., commercializing SCINTIX biology-guided radiotherapy, a novel treatment modality that uses a single radiotracer injection to transform cancer cells into real-time biological beacons to control external-beam radiotherapy delivery to multiple tumors. Granted Breakthrough Device designation for lung tumors and De Novo marketing authorization by the FDA, SCINTIX therapy is indicated for use in lung and bone tumors and will be expanded to all cancer indications suitable for BgRT treatment. The RefleXion X1 is also cleared for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS), and intensity modulated radiotherapy (IMRT) for solid tumors located anywhere in the body.
Eckert & Ziegler AG
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Karolin Riehle, Investor Relations / Jan Schöpflin, Marketing
karolin.riehle@noSpamezag.de / jan.schoepflin@noSpamezag.de
Tel.: +49 (0) 30 / 94 10 84-138; www.ezag.com
Telix Pharmaceuticals Limited
Ms. Kyahn Williamson
SVP Corporate Communications and Investor Relations
RefleXion Medical, Inc.