[212Pb]Pb-ADVC001

Thorium-228 (228Th) is the parent isotope and key starting material to produce the alpha-emitter Lead-212 (212Pb) The established capability to receive and process high-activity 228Th, provides a key competitive advantage in scaling up 212Pb production to support the rapid advancement of 212Pb-ADVC001 (ADVC001) clinical development and the expanding pipeline The received 228Th will be processed into sources for our proprietary generator and installed in production systems first in Australia and subsequently in the US, as part of the planned expansion SYDNEY & BOSTON--(BUSINESS WIRE)--AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced it has received the first delivery of high-activity 228Th, the parent isotope of 212Pb and a key starting material to produce the alpha-emitter 212Pb, used to manufacture ADVC001, the company’s lead asset, and other 212Pb-based radioligand therapies in the pipeline. This delivery marks a major milestone for the company and underscores the industry leading infrastructure and operational capabilities in place at the flagship facility in Brisbane, Australia – supported by a highly specialized and experienced team with unique industry expertise. This distinct capability gives AdvanCell a strong competitive edge as it accelerates the scale-out of 212Pb production in view of the rapid advancement of ADVC001 clinical development and the expanding pipeline. The received 228Th will be processed into sources for the company’s proprietary generator and installed in production systems – first in Australia and subsequently in the US as part of the planned expansion. This capability will enable the high-volume manufacture of hundreds of clinical doses of ADVC001, ensuring a reliable supply for the upcoming clinical demand and strengthening AdvanCell’s position as it advances development across its growing portfolio. The company’s end-to-end vertical integration, spanning from raw material processing to final drug product, sets it apart in the radioligand therapy space and empowers it to move with unmatched speed in the field. “High-activity thorium is the foundation for efficient and reliable production of 212Pb, and our ability to process it in Australia and supply both domestic and our planned US operations position us for our next important phase of growth.” said Andrew Adamovich, Founder and CEO of AdvanCell “This capability ensures we can advance ADVC001 through Phase 2 and pivotal trials and advance our pipeline of targeted alpha therapies.” AdvanCell would like to especially acknowledge our partners at the National Isotope Development Center (NIDC) and the DOE U.S. Department of Energy Isotope Program (DOE IP), which funds the NIDC, as a key supplier of 228Th for AdvanCell. NIDC serves as an interface with the user community and manages the coordination of isotope production across the program facilities at Argonne, Brookhaven, Idaho, Los Alamos, Oak Ridge, and Pacific Northwest National Laboratories. These facilities produce stable and radioactive isotopes in short supply using reactors, accelerators, and other methods. About 212Pb-ADVC001 212Pb-ADVC001 (ADVC001) is a proprietary and patented PSMA-targeting radioligand with optimized physicochemical properties and labelled with 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) during the dose-finding Phase 1b (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 rigorously evaluate optimal dosing strategies of ADVC001 in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) and in metastatic hormone-sensitive prostate cancer (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.

Clinical development of 212Pb-ADVC001 (ADVC001) is advancing rapidly with encouraging Phase 1b data presented at ESMO 2025 The Phase 2 expansion will evaluate 160 MBq and 200 MBq doses of ADVC001 using a randomized, multi-dose-response design and adaptive dosing strategies to optimize clinical outcomes across three indications: metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC) in pre-chemotherapy and post-177Lu-PSMA radioligand therapy (RLT) settings SYDNEY & BOSTON--(BUSINESS WIRE)--AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced the initiation of the TheraPb Phase 2 expansion trial (NCT05720130) evaluating its lead investigational candidate, ADVC001, in metastatic prostate cancer. The news follows the encouraging Phase 1b dose escalation results presented at the European Society for Medical Oncology (ESMO) 2025 congress that showed a favorable safety profile and compelling anti-tumor activity for ADVC001 in patients with mCRPC (see press release). ADVC001 is a first-in-class 212Pb-PSMA RLT in clinical development, with early data indicating a differentiated and competitive profile both within and beyond its class. Development is advancing rapidly; the Phase 1b therapeutic cohorts were enrolled within ten months, and the commencement of Phase 2 expansion sustains this strong program momentum. The TheraPb Phase 2 expansion will evaluate ADVC001 at two therapeutic dose levels – 160 MBq and 200 MBq – using a randomized, multi-dose-response design aligned with the US Food and Drug Administration (FDA) guidance on dose optimization for oncology therapeutic radiopharmaceuticals1. The study will incorporate novel dosing strategies and the option for treatment with more than six cycles, supported by the favorable dosimetry and pharmacokinetics data from Phase 1b, to optimize clinical outcomes across three key prostate cancer indications: mHSPC : patients with metastatic hormone-sensitive prostate cancer mCRPC, pre-chemotherapy : patients with mCRPC who have not received prior chemotherapy for mCRPC mCRPC, post-177Lu-PSMA RLT : patients with mCRPC who have been previously treated with 177Lu-PSMA Enrollment for the TheraPb Phase 2 expansion is expected to commence initially at clinical sites in Australia, with planned expansion to sites in the United States in 2026. “We are excited to initiate the Phase 2 expansion, marking an important milestone in advancing our novel alpha therapy for prostate cancer,” said Anna Karmann, MD PhD, Chief Medical Officer at AdvanCell. “Our Phase 1 results enable us to evaluate optimal dosing regimens that support a precision treatment strategy aligned with tumor biology and individual response, underscoring our commitment to deliver better clinical outcomes and quality of life for patients living with metastatic prostate cancer.” “As ADVC001 enters Phase 2, I am eager to begin enrollment in this study,” said Aaron Hansen, MD, Principal Investigator at the Princess Alexandra Hospital. “ADVC001 has demonstrated a highly promising safety and efficacy profile in Phase 1, supporting its investigation in multiple settings. The adaptive dosing and the ability to treat with more than six cycles offer the potential to meaningfully improve clinical benefit and are a step towards more personalized treatment for patients with prostate cancer.” AdvanCell plans to present additional details on the TheraPb Phase 2 expansion trial design at a major oncology conference in the first half of 2026. 1US Food and Drug Administration (2025, August) “Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development – Guidance for Industry (Draft Guidance)” xxx About 212Pb-ADVC001 212Pb-ADVC001 (ADVC001) is a proprietary and patented PSMA-targeting radioligand with optimized physicochemical properties labelled with 212Pb, an alpha-emitting payload (radionuclide) with a high dose rate, 10.6 hours 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 designed to determine the safety and tolerability of escalating doses of ADVC001 administered every 6, 4, 2 or 1 week(s) during the dose-finding Phase 1b. The Phase 2 expansion will assess the efficacy and safety of ADVC001 at the recommended Phase 2 doses across three indications. The trial utilizes a randomized dose-response design and dose optimization elements to rigorously evaluate optimal dosing strategies of 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 212Pb (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.