AdvanCell Presents Updated Phase 1 Results on ADVC001 at ESMO 2026 with Encouraging Long-term Data

• With a median follow-up of over 14 months, ADVC001, a novel Lead-212 PSMA therapy, continues to show favorable tolerability with no new safety signals in metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer
• Encouraging activity is seen at the two selected recommended Phase 2 doses (RP2D), 160 and 200 MBq, with a PSA50 response in 80% of patients and a 100% overall response rate (ORR) in RECIST-evaluable patients
• Median radiographic progression-free survival (rPFS) is 11.2 months at the RP2D as of data cut-off
• Phase 2 enrollment is ongoing to evaluate the RP2D in metastatic androgen pathway modulation-sensitive (mAPMS) and mAPMR prostate cancer, incorporating a novel induction, maintenance and response-adapted ADVC001 dosing strategy

BOSTON & BRISBANE, Australia--(BUSINESS WIRE)--AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced updated results from the TheraPb Phase 1 clinical trial (NCT05720130), evaluating ADVC001, an investigational Lead-212 PSMA-targeted alpha therapy, in patients with mAPMR prostate cancer (formerly referred to as mCRPC). The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

The study evaluated escalating doses of 60–200 MBq ADVC001 administered at pre-specified intervals every 6, 4, 2 or 1 week(s), for up to 6 cycles, enabling RP2D selection of dose and schedule. Expanding upon the initial results reported at ESMO 2025, the updated TheraPb Phase 1 data presented in Madrid provides an additional 12 months of safety and efficacy follow-up.

“The longer follow-up data presented at ESMO underscore the potential for ADVC001 to deliver durable clinical benefit while maintaining a favorable safety profile,” said Christopher Sweeney, MBBS, Director of the South Australian immunoGENomics Cancer Institute. “These findings support further clinical development of this targeted alpha therapy to address the significant unmet needs of patients with metastatic prostate cancer.”

The results presented include follow-up from the 22 patients enrolled across seven dose-schedule cohorts, with a median follow-up of 14.1 months as of the 5 October 2026 data cut-off (open database). Treatment was well tolerated with most patients having completed all 6 planned doses per protocol. At RP2D 160 and 200 MBq, an 80% PSA50 response rate was seen corresponding with decreases in PSMA avid tumor volume on PSMA PET and 100% ORR (5/5 confirmed responses) by BICR in patients with RECIST-measurable target lesions. Median rPFS was 11.2 months at the RP2D, as of data cut-off.

“The updated Phase 1 results from the TheraPb trial demonstrate a favorable safety and tolerability profile for ADVC001, with no new safety signals emerging after an additional 12 months of follow-up,” said Aaron R. Hansen, MBBS, Principal Investigator at Princess Alexandra Hospital. “Encouraging and sustained anti-tumor activity was observed at the RP2D. These findings support the continued Phase 2 evaluation of ADVC001, incorporating an optimized induction and maintenance dosing strategy aimed at enhancing the depth and durability of clinical benefit for patients with metastatic prostate cancer.”

“We thank the patients and their families, investigators, site staff, and collaborators for their commitment, partnership and contributions to this study,” said Anna Karmann, MD PhD, Chief Medical Officer, AdvanCell. “These data support the continued development of ADVC001 as a potential treatment option for men with prostate cancer, and we look forward to further evaluating its therapeutic potential in ongoing and future studies.”

ADVC001 continued to show a favorable safety profile and signs of sustained anti-tumor activity. The updated findings reinforce the promising therapeutic profile of ADVC001 and support further investigation and dosage optimization. Phase 2 enrollment is ongoing to evaluate the RP2D of 160 MBq and 200 MBq in mAPMS and mAPMR prostate cancer and incorporates a novel induction, maintenance and response-adapted ADVC001 dosing strategy with up to 12 doses aiming to enhance and prolong clinical benefit.

The poster presentation is available on AdvanCell’s website at: AdvanCell ESMO 2026 Poster

About ADVC001
ADVC001 is a proprietary and patented PSMA-targeting radiopharmaceutical therapy with optimized physicochemical properties labelled with Lead-212, an alpha-emitting payload 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 and treatment schedules of ADVC001 during the dose-finding Phase 1. The Phase 2 expansion evaluates the efficacy and safety of ADVC001 at the recommended Phase 2 doses 160 and 200 MBq. The trial utilizes dosage optimization strategies to enhance outcomes in PSMA-positive mAPMR and in mAPMS.

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 manufacturing and clinical development capabilities, AdvanCell aims to deliver novel treatments that improve outcomes for patients with cancer. For more information, visit www.advancell.com.au and follow us on LinkedIn.