AdvanCell Receives First Delivery of High-Activity Thorium-228, Highlighting a Unique Industry Capability and Expertise Essential to Scaling Lead-212 Production for Targeted Alpha Therapies

• 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.