AdvanCell Establishes U.S. Global Headquarters and Secures Flagship Manufacturing Facility in Greater Boston to Drive Growth Strategy

• New 128,000-square-foot facility in Andover will serve as U.S. global headquarters and future manufacturing center supporting the development and commercialization of ADVC001 and the Company’s pipeline of Lead-212 targeted alpha therapies

• Expanding U.S. operations complement the Company’s established Australian R&D and manufacturing capabilities to create a global, vertically integrated platform for radiopharmaceutical development and commercial supply

BOSTON & BRISBANE, Australia--(BUSINESS WIRE)--AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced the establishment of its U.S. Global Headquarters in the Greater Boston area, and the lease of a new 128,000-square-foot facility that will become the Company’s U.S. flagship manufacturing center supporting its long-term growth and commercialization strategy. The expansion marks an important milestone in the Company’s evolution into a U.S.-based radiopharmaceutical company with integrated operations spanning North America and Australia.

The investment reflects AdvanCell's strategy to expand its U.S. presence and build the infrastructure needed to support the development and future commercialization of ADVC001 and its Lead-212 targeted alpha therapy pipeline.

Located in Greater Boston, the Innovation Park campus owned by IQHQ provides access to a world-class life-science ecosystem, supporting the next phase of the Company’s growth. The Andover facility will serve as the Company’s U.S. Global Headquarters, bringing together corporate operations and state-of-the-art manufacturing capabilities.

“Establishing AdvanCell’s U.S. Global Headquarters and future manufacturing facility reinforces our commitment to U.S. expansion and represents an important milestone in AdvanCell’s strategy to build a global, vertically integrated targeted alpha therapy company,” said Philina Lee, PhD, CEO of AdvanCell. “As we advance ADVC001 and our broader Lead-212 pipeline, our Andover facility will be a cornerstone of our U.S. expansion and our first internal manufacturing site in the U.S., providing the foundation to scale production to support future clinical and commercial demand. We will continue to leverage the strengths of our Australian operations - including rapid clinical translation, isotope supply capabilities and process innovation - as we advance our Lead-212 targeted alpha therapies for patients globally.”

As part of its U.S. manufacturing expansion strategy, AdvanCell is also working with a leading contract development and manufacturing organization (CDMO) to establish drug product manufacturing capabilities in addition to the Andover facility fit out and qualification. This approach is expected to accelerate access to U.S.-based manufacturing capacity, supporting Phase 2 enrolment of the TheraPb study (NCT05720130) in the U.S. while the Company further builds its Phase 3 and commercial manufacturing infrastructure.

About 212Pb-ADVC001

212Pb-ADVC001 (ADVC001) is a proprietary and patented PSMA-targeting radioligand with optimized physicochemical properties and labelled with Lead-212 (212Pb), an alpha-emitting payload (radionuclide) with a high dose rate, 10.6-hour half-life and simple decay scheme. ADVC001 is designed to deliver radiation at a cellular level to effectively kill prostate cancer cells while minimizing toxicity.

About the TheraPb trial

The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose escalation and expansion study evaluating ADVC001 in metastatic prostate cancer. The completed Phase 1b dose escalation assessed the safety and tolerability of escalating doses of ADVC001 administered every 6, 4, 2 or 1 week(s) (see press release). The Phase 2 expansion is assessing the efficacy and safety of ADVC001 at two dose levels. The trial utilizes a randomized dose-response design and dose optimization elements to evaluate ADVC001 in PSMA-positive mCRPC and in mHSPC.

About AdvanCell

AdvanCell is a vertically integrated, clinical-stage radiopharmaceutical company dedicated to developing innovative cancer therapies that harness the power of targeted alpha-emitting radionuclides. By leveraging its proprietary Lead-212 platform, advanced and scalable manufacturing and world-class clinical development capabilities, AdvanCell aims to deliver novel treatments that improve outcomes for patients with cancer globally. For more information, visit www.advancell.com.au and follow us on LinkedIn.