Convergent Therapeutics and NorthStar Medical Radioisotopes Announce Expanded Partnership to Support Convergent's Late-Stage Alpha-Emitting Radioantibody Program

Purpose-built facility secures Convergent’s drug product manufacturing at the scale needed to meet late-stage CONV01-α clinical studies and commercial demand

Expanded partnership designed to drive economies of scale across drug-product manufacturing and high-purity Actinium-225 (Ac-225) isotope production

CAMBRIDGE, Mass. & BELOIT, Wis.--(BUSINESS WIRE)--Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, and NorthStar Medical Radioisotopes (NorthStar), a leading radiopharmaceutical company, today announced an expanded agreement under which Convergent will support its drug development and clinical batch production with dedicated manufacturing suites on NorthStar’s Beloit, Wisconsin campus.

Co-locating Convergent’s manufacturing at NorthStar establishes an integrated and reliable supply chain for CONV01-α drug product production with Ac-225, relieving supply constraints for alpha-based radiotherapies and supporting Convergent’s ongoing clinical trials through to commercial production.

“The relationship with NorthStar enables us to fully realize the potential of our leading radioantibody program as we demonstrate the advantages of alpha emitters in addressing metastatic castration-resistant prostate cancer (mCRPC) and the significant need for new, safer, and more effective therapies for patients. With secured Ac-225 supply, clinical proof-of-concept, and potential best-in-class efficacy and tolerability, CONV01-α is well-positioned to advance mCRPC treatment,” said Convergent CEO and Co-Founder Philip Kantoff, M.D. “Our strategic investment in manufacturing will support late-stage monotherapy studies of CONV01-α, and additional trials to assess CONV01-α in earlier stages of prostate cancer and in combination with other therapeutics.”

CONV01-α, Convergent’s lead program for mCRPC and other radiopharmaceuticals in its pipeline, leverage the power and precision of alpha-emitting isotopes. NorthStar recently announced it now produces alpha radioisotopes for therapeutic applications at scale, with Convergent as a key customer for Ac-225. Reliable Ac-225 supply further supports Convergent’s ability to deliver the next generation of alpha-based radiotherapies, building on the precision and tolerability advantages demonstrated in clinical trials to date with CONV01-α.

“We are pleased to expand our partnership with Convergent,” said Frank Scholz, President and CEO of NorthStar Medical Radioisotopes, LLC. “This agreement underscores the value of our integrated campus designed to reduce complexity and create a robust, reliable supply chain to deliver patient-ready drugs.”

In August 2024, NorthStar and Convergent announced a strategic contract manufacturing services agreement to provide Convergent with Ac-225 for use in CONV01-α and to utilize NorthStar’s new state-of-the-art contract development and manufacturing facility to manufacture CONV01-α for Convergent’s clinical trials and perform research and development activities.

“Having drug product and Ac-225 supply co-located on the NorthStar campus provides a unique advantage for our supply chain, enabling greater efficiencies, flexibility, and cost savings, as we leverage NorthStar’s extensive track record in radiopharmaceutical manufacturing,” said Caitlyn Harvey, Head of Manufacturing at Convergent. “Their leadership in producing alpha emitters for radiotherapies ensures critical production capabilities and access to Ac-225 are in place for pivotal studies through commercial launch and beyond.”

About CONV01-α

CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of metastatic castration-resistant prostate cancer (mCRPC), uses a humanized monoclonal antibody directed at prostate-specific membrane antigen (PSMA), a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver Actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.

About Convergent Therapeutics, Inc.

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radioantibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radioantibodies precisely target cancer cells with potent, localized radiation. Visit: www.convergentrx.com

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 the first commercial-scale producer of non-carrier added actinium-225 (n.c.a. 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