Boston– AdvanCell has established its U.S. global headquarters in Greater Boston and leased a 128,000-square-foot facility in Andover that will serve as its flagship U.S. manufacturing center.
The clinical-stage radiopharmaceutical company said the facility will support the development and potential commercialization of ADVC001 and its pipeline of Lead-212 targeted alpha therapies for cancer.
The expansion is part of AdvanCell’s effort to build a vertically integrated global operation spanning the United States and Australia. The Andover site, located at IQHQ’s Innovation Park campus, will combine corporate operations with 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.”
AdvanCell is also working with a contract development and manufacturing organization to establish additional U.S. drug manufacturing capacity while the Andover facility is fitted out and qualified.
The company said the strategy is expected to support U.S. enrollment in the Phase 2 portion of its TheraPb study while it develops manufacturing infrastructure for a potential Phase 3 trial and future commercial production.
ADVC001 is a proprietary PSMA-targeting radioligand labeled with Lead-212, an alpha-emitting radionuclide with a 10.6-hour half-life. The therapy is designed to deliver radiation directly to prostate cancer cells while limiting toxicity to surrounding tissue.
The prospective, open-label Phase 1/2 TheraPb trial is evaluating ADVC001 in patients with metastatic prostate cancer. The completed Phase 1b dose-escalation portion assessed the safety and tolerability of doses administered at intervals ranging from one to six weeks.
The Phase 2 expansion is evaluating the treatment’s efficacy and safety at two dose levels in patients with PSMA-positive metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer.
