NorthStar Medical Radioisotopes and Convergent Therapeutics Announce Supply Agreement for Therapeutic Radioisotope Actinium-225 (Ac-225)

− NorthStar’s high purity non-carrier-added (n.c.a.) Ac-225 to be used in Convergent’s lead, dual-targeted radionuclide program for prostate cancer, CONV01-α −

BELOIT, Wis. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Convergent Therapeutics, Inc., a clinical stage radiopharmaceutical company, today announced the signing of a long-term supply agreement for the therapeutic medical radioisotope, actinium-225 (Ac-225). Under terms of the agreement, NorthStar will provide Convergent with its environmentally preferred, high purity non-carrier-added (n.c.a.) Ac-225. Convergent will use NorthStar’s Ac-225 to radiolabel its lead asset, CONV01-α, a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody, currently being investigated as a potential ground-breaking treatment for prostate cancer.

Ac-225 is a high energy alpha-emitting radioisotope of increasing interest for clinical studies investigating the use of targeted radiopharmaceutical therapy (RPT), which combines select molecules with therapeutic radioisotopes, such as Ac-225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while its half-life limits unwanted radioactivity in patients. Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technology. NorthStar is positioned to be the first commercial-scale producer of Ac-225 for advancing clinical research and commercial radiopharmaceutical products. The Company will use its environmentally-sound electron accelerator technology to produce n.c.a. Ac-225 that is free of long-lived radioactive contaminants and byproducts associated with other production methods, which pose regulatory and waste management challenges for hospitals and health systems.

“NorthStar is applying the same development expertise to rapidly advance large-scale production of n.c.a. Ac-225 that has positioned us at the forefront of U.S. radioisotope production as the only commercialized producer of the important medical radioisotope molybdenum-99 (Mo-99),” said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. “Like all NorthStar processes, our n.c.a. Ac-225 production technology is environmentally sustainable and non-uranium based, utilizing state-of-the-art electron beam accelerator production that provides increased capacity and scheduling flexibility. Facility design is complete and we expect construction to be underway soon on our dedicated Actinium-225 Production facility, with initial production of radiochemical grade Ac-225 planned for late 2023, and a Drug Master File to be submitted to the FDA in 2024, which, upon acceptance by the FDA, will allow NorthStar to provide cGMP grade Ac-225. We are very pleased to enter this Ac-225 supply agreement with Convergent Therapeutics, and we look forward to working with them moving forward. Our companies share a vision of developing and delivering innovative technology to drive research and ensure clinical availability of targeted radiopharmaceutical therapies for patients with cancer.”

“Convergent has demonstrated that dual targeting of surface cancer molecules, like prostate-specific membrane antigen (PSMA), improves antitumor efficacy and may represent a truly disruptive and advantageous therapeutic option to treat prostate cancer,” said Philip Kantoff, M.D., Chief Executive Officer of Convergent Therapeutics. “Our lead candidate, CONV01-α, is a monoclonal antibody radiolabeled with Ac-225, and is specifically designed to bind to PSMA, which is highly expressed in most prostate cancer. Once bound, CONV01-α becomes internalized, enabling delivery of supra-additive therapeutic doses of radiation directly into prostate cancer cells. The power of labeling CONV01-α with an alpha-emitting radioisotope such as Ac-225 is in its ability to maximize antitumor impact while minimizing radiation to adjacent tissue. NorthStar is our ideal partner for Ac-225 supply based on their leadership experience and commercial expertise in cutting-edge, accelerator-based radioisotope production technology. We look forward to working with NorthStar to supply Ac-225 for our clinical studies and future commercialization needs as we seek to deliver highly transformative treatments for patients with prostate and other cancers.”

About Convergent Therapeutics, Inc.

Convergent Therapeutics, Inc. is a clinical stage pharmaceutical company focused on developing next generation radiopharmaceutical therapies for prostate and other cancers. The company's proprietary technology involves dual-targeted radionuclide therapy (RNT) developed by Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine and licensed to Convergent by Cornell University. CONV01-α, a monoclonal antibody conjugated with actinium-225 (²²⁵Ac), a radioactive alpha particle emitter, was specifically designed to bind to the prostate-specific membrane antigen (PSMA). A key functional feature of CONV01-α is that, once bound to PSMA, it becomes internalized, thereby delivering its powerful radioactive payload directly into the prostate cancer cells. CONV01-α is covered by multiple issued U.S. and foreign patents. If FDA-approved, CONV01-α would be the first antibody approved to direct a radioisotope to prostate cancer, and the first drug approved for the use of ²²⁵Ac in a cancer treatment. For more information, please visit: www.convergentrx.com.

About NorthStar Medical Radioisotopes, LLC (NorthStar)

NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company that manufactures and distributes diagnostic and therapeutic radiopharmaceuticals. The Company’s proprietary state-of-the-art technology and proven management team have propelled it to the forefront of U.S. medical radioisotope production as the sole domestic producer of the diagnostic imaging radioisotope molybdenum-99 (Mo-99). Mo-99 is used to generate technetium-99m (Tc-99m), the standard of care in diagnostic imaging to assess the extent and severity of heart disease and cancer. NorthStar’s unique Mo-99 production process is non-uranium based and environmentally friendly. NorthStar is expanding its industry-leading position in the emerging area of therapeutic radioisotopes, which are used in targeted radiopharmaceutical therapy to treat cancer, respiratory and other diseases. Using first-in-kind and environmentally-sound electron accelerator technology, NorthStar is poised to be the first commercial-scale producer of therapeutic radioisotopes actinium-225 (Ac-225) and copper-67 (Cu-67). For more information about NorthStar’s comprehensive radiopharmaceutical portfolio, visit: www.northstarnm.com.

For NorthStar Medical Radioisotopes, LLC
Corporate:
Lisa Holst
Vice President Sales and Marketing
678-471-9027
lholst@northstarnm.com

Investor Relations:
Paul Estrem
Executive Vice President and Chief Financial Officer
608-987-8318
pestrem@northstarnm.com

Media:
Priscilla Harlan
781-799-7917
pharlan@shiningrockllc.com

For Convergent Therapeutics, Inc.
Rx Communications Group
Paula Schwartz
917-322-2216
pschwartz@rxir.com