• Agreement between NorthStar and major U.S. research institution aims to shift treatment paradigms and find a cure for a group of inflammatory diseases which affect small blood vessels in organs including the kidneys, lungs, skin and nervous system, among others
• Multi-faceted study will include projects focused on the use of radionuclides¹ for diagnosis and treatment, innovative precision immunotherapy approaches, and work to decode abnormalities of the immune system that are causing these diseases

NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, today announced that it has entered into a sponsorship agreement with an undisclosed major U.S. research institution which will undertake an investigator-initiated research project entitled “Program to Find a Cure for ANCA-associated Vasculitis Through Research”.

The Study will be conducted at the undisclosed research institution under the direction of a private physician and researcher, who will be responsible for designing the study protocol and initiating and conducting the study. The study has four underlying projects. One will investigate how to best develop and validate both noninvasive PET imaging to identify inflamed tissue in ANCA-associated vasculitis and radionuclide therapy that selectively targets autoreactive B cells² to treat this form of vasculitis.

The other three project arms include:

• establishing basic administrative tasks (e.g. program coordination, biospecimen collection, data base maintenance etc.)
• identifying new precision immunotherapies that will selectively target and eliminate autoreactive B cells in ANCA-associated vasculitis
• singling-out and ‘decoding’ antigen-specific B cells in ANCA-associated vasculitis in order to address autoimmune reactions that contribute to inflammation of the vessels.

Upon completion, the institution and the physician will be free to publish, present, or use data and results arising out of the research.

“At NorthStar, we believe we’re on the cusp of a global paradigm shift in the development and commercialization of effective new radiodiagnostics and radiotherapies that can potentially be applied to rare, complex conditions such as ANCA-associated vasculitis,” said Dr. Frank Scholz, NorthStar’s President and Chief Executive Officer. “By supporting this broad research program, NorthStar can expand our horizons past cancer diagnosis and therapies and play a key role in the effort to find a cure for this constellation of complex conditions. This study is expected to give us better insight into the role of inflammation itself in the progression of different vascular pathologies, and help identify new or alternative diagnosis and treatments that could more easily address diseases where vascular inflammation is playing a key role. Use of these novel pathways could also lead to a better understanding of underlying disease mechanisms and help us establish which patients are appropriate for emerging immune-modulating therapies.”

About ANCA-associated vasculitis.

Anti-Neutrophil Cytoplasmic Antibody (ANCA) Associated Vasculitis is a group of diseases, characterized by destruction and inflammation of small vessels. The clinical signs vary and can affect several organs, such as the kidney, lung, skin, nervous system and others.

About NorthStar Medical Radioisotopes, LLC (NorthStar)

NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com.

¹ In medicine, radionuclides or radioisotopes are chemical elements used in diagnostic imaging tests and in treatment.

² Cells that secrete cytokines (signaling proteins) that influence inflammation in the human body.

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