AdvanCell Establishes U.S. Headquarters and Manufacturing Facility in Greater Boston, Strengthens Executive Team to Scale Lead-212 Targeted Alpha Therapy Platform
核心洞察
AdvanCell has established its U.S. Global Headquarters in Greater Boston with a 128,000-square-foot flagship manufacturing facility to support development and commercialization of its Lead-212 targeted alpha therapies.
The company appointed Justyna Kelly as Chief Technology Officer and François Gaudet as Chief Scientific Officer, bringing extensive radiopharmaceutical manufacturing and oncology drug discovery expertise.
ADVC001, a PSMA (搜索)-targeting radioligand labeled with Lead-212, is currently in a Phase 1/2 TheraPb trial (NCT05720130) evaluating safety and efficacy in metastatic prostate cancer.
AdvanCell, a clinical-stage radiopharmaceutical company, has announced the establishment of its U.S. Global Headquarters in the Greater Boston area alongside the lease of a new 128,000-square-foot facility in Andover that will serve as its flagship U.S. manufacturing center. The expansion, announced June 22, 2026, marks a significant milestone in the company's evolution into a U.S.-based radiopharmaceutical enterprise with integrated operations spanning North America and Australia.
The Andover facility, located on the Innovation Park campus owned by IQHQ, will house both corporate operations and state-of-the-art manufacturing capabilities, providing the infrastructure needed to support the development and future commercialization of ADVC001 and the company's broader pipeline of Lead-212 targeted alpha therapies.
"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."
Executive Leadership Strengthened for U.S. Expansion
In a complementary move announced June 8, 2026, AdvanCell appointed two senior executives to its U.S.-based leadership team. Justyna Kelly, MSc, joined as Chief Technology Officer, bringing 16 years of radiopharmaceutical manufacturing and operations experience. She most recently served as Vice President and Site Head of Eli Lilly and Company's Indianapolis radioligand therapy manufacturing site, and previously held the role of Chief Operating Officer at POINT Biopharma (搜索) prior to its acquisition by Lilly.
Kelly will lead AdvanCell's global technical operations strategy, including CMC, GMP production and clinical supply, the company's global manufacturing network, supply chain, and preparation for commercial readiness. "AdvanCell has built a differentiated Lead-212 platform with the potential to meaningfully impact patients with cancer," said Kelly. "I am excited to join the team and help execute a holistic strategy to scale our Lead-212 manufacturing infrastructure for Phase 3 and commercial readiness, while ensuring the quality, reliability, and operational excellence needed to deliver these therapies to patients."
François Gaudet, PhD, assumed the role of Chief Scientific Officer, bringing 25 years of experience across pharmaceutical and biotechnology companies, including leadership roles at Novartis, Johnson & Johnson, and Mnemo Therapeutics. He has led research teams responsible for the discovery and development of innovative therapeutic assets through commercialization, including TECVAYLI and TALVEY. Dr. Gaudet conducted his graduate work in cancer epigenetics at the Massachusetts Institute of Technology and holds a PhD in Biology from Ludwig Maximilians Universität.
"Lead-212 alpha therapy is a nascent field and ADVC001 represents a validation of the modality," said Gaudet. "I'm excited to have joined the team to continue driving forward the pipeline development and help realize the full potential of the company's differentiated approach."
Simon Puttick, PhD, transitioned from Chief Scientific Officer to Chief Isotope Development Officer, with a dedicated mandate to advance the company's next-generation isotope production technologies and strengthen supply chain security. He will continue to be based at the company's Australian headquarters in Brisbane.
ADVC001 and the TheraPb Trial
ADVC001 is a proprietary, patented PSMA (搜索)-targeting radioligand labeled with Lead-212, an alpha-emitting radionuclide with a high dose rate, 10.6-hour half-life, and simple decay scheme. The therapy is designed to deliver radiation at a cellular level to effectively kill prostate cancer cells while minimizing toxicity.
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). The ongoing Phase 2 expansion is assessing efficacy and safety at two dose levels, utilizing a randomized dose-response design with dose optimization elements to evaluate ADVC001 in PSMA (搜索)-positive metastatic castration-resistant prostate cancer (搜索) (mCRPC) and metastatic hormone-sensitive prostate cancer (搜索) (mHSPC).
Manufacturing Strategy
As part of its U.S. manufacturing expansion, 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 dual approach is expected to accelerate access to U.S.-based manufacturing capacity, supporting Phase 2 enrollment of the TheraPb study in the U.S. while the company builds its Phase 3 and commercial manufacturing infrastructure.
The company will continue to leverage its established Australian operations, including rapid clinical translation, isotope supply capabilities, and process innovation, as it advances its Lead-212 targeted alpha therapies for patients globally.