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

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  • 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, October 23, 2026--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.

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