June 23, 2020 - Garching/Munch, Germany & Toronto - ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and POINT Biopharma Inc., a clinical oncology company, announced today that they have signed two supply agreements for the medical radioisotope no-carrier-added Lutetium-177 (n.c.a. 177Lu) / EndolucinBeta® to support clinical and commercial supply of PNT2002, a 177Lu-PSMA radiopharmaceutical for prostate cancer treatment.
Under the terms of the first agreement, ITM has partnered with POINT Biopharma for their clinical development of PNT2002, a 177Lu-PSMA radiopharmaceutical for the treatment of metastatic castrate-resistant prostate cancer. PNT2002 is a radiopharmaceutical candidate with an excellent profile and will be investigated in a phase III clinical trial launching with the enrollment of patients in the fourth quarter of 2020. Additionally, both parties signed a long-term commercial agreement for the supply of n.c.a. 177Lu following the marketing approval of PNT2002. Further terms of the agreements are not disclosed.
ITM’s no-carrier-added Lutetium-177 (brand name EndolucinBeta®) is a radiopharmaceutical precursor used for Targeted Radionuclide Therapy in Precision Oncology. ITM manufactures n.c.a. 177Lu for development partnerships, distribution to clinics worldwide, and its own growing Precision Oncology Pipeline. N.c.a. 177Lu has marketing authorization in the EU and DMF in the US. Radiolabeled to disease-specific targeting molecules like antibodies or peptides, the tumor tissue is precisely targeted and destroyed by cytotoxic doses of medium-energy ionizing radiation. ITM has developed a unique methodology to produce a highly pure form of Lutetium-177, containing no metastable Lutetium-177m.
POINT Biopharma has a growing portfolio of best in class pharmaceutical assets and is working to revolutionize radiopharmaceutical drug development and commercialization for cancer treatment. The company specializes in radioligand therapies and is committed to bringing them to market quickly. The company anticipates its clinical trial programs to commence in 2020.
“ITM has a proven track record of exceeding market demands. Choosing the right partner, with significant capacity, is critical to meeting the needs of our future patients”, said Dr Joe McCann, CEO of POINT Biopharma. “We look forward to using these radioisotopes for our upcoming products including in our phase three prostate cancer trial starting this year,” Dr McCann added.
Steffen Schuster, CEO of ITM, commented: “Like ITM, POINT Biopharma is eager to improve treatment outcomes and quality of life of cancer patients with Targeted Radionuclide Therapies. We are very pleased to establish this long-term alliance making significant contribution to innovative and promising therapies for cancer patients worldwide.” About ITM Isotopen Technologien München ITM Isotopen Technologien München AG is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of a novel, first-in-class medical radioisotopes 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 tumors, glioblastoma, osteosarcoma and bone metastases, as well as folate receptor α positive tumors such as lung, ovarian or breast cancer. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve treatment 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 please visit: www.itm.ag