June 23, 2020

ITM and POINT Biopharma Sign Two Supply Agreements for No-carrier-added Lutetium-177

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