On June 23, 2020 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and POINT Biopharma Inc., a clinical oncology company, reported 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 (Press release, ITM Isotopen Technologien Munchen, JUN 23, 2020, View Source [SID1234561415]).
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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."