AdvanCell Commences Drug Product Manufacture from its Facility in Queensland, Australia
October 8th, 2024, SYDNEY AUSTRALIA – AdvanCell has commenced drug product manufacture from its facility in Richlands for the ongoing TheraPb trial.
On Wednesday, October 2nd, the first patient was successfully dosed with 212Pb-ADVC001 produced at the Company’s 40,000-square-foot flagship manufacturing site. Previous trial doses had been made at licensed research facilities and collaborator sites. This manufacture from AdvanCell’s own premises marks a new chapter – enabling higher activity doses to meet the demands of the rapidly progressing trial.
“This is an important milestone for our Company. With our proprietary 212Pb isotope production technology, our talented team and our facility, AdvanCell is uniquely well positioned to scale up clinical dose supply to support our ongoing trials, our pipeline and partner programs as a fully vertically integrated radiopharmaceutical company,” says AdvanCell CEO Andrew Adamovich.
“I’m very proud of our team for establishing investigational drug product manufacturing in record time. Our excitement for Targeted Alpha Therapy continues to grow, as these are highly promising treatment modalities with unique mechanisms of action. AdvanCell is investigating 212Pb-based targeted alpha therapies for indications for which there are limited options.
AdvanCell is preparing for a GMP license to support late-stage clinical development of the Company’s product pipeline in Australia and expansion into North America in 2025.
AdvanCell continues to collaborate with manufacturing partners to supply investigational products for its clinical programs and looks forward to expanding clinical trial sites in Australia and globally.
About AdvanCell:
AdvanCell is a vertically integrated, clinical-stage radiopharmaceutical company developing novel targeted alpha therapies to improve survival and quality of life for patients with cancer. AdvanCell is currently running its TheraPb clinical trial for ADVC001, its highly promising therapy for metastatic castration-resistant prostate cancer in a world-first Phase I/II study at Metro South Health’s Princess Alexandra Hospital and Metro North Health‘s Royal Brisbane & Women’s Hospital, and has a number of other programs in development and expected to enter the clinic in 2025.
