- \n
- Results from the TheraPb Phase 1b dose escalation presented at ESMO 2025 show a promising therapeutic index for 212Pb-ADVC001 in patients with metastatic castration-resistant prostate cancer (mCRPC)<\/li>\n
- No dose-limiting toxicities and no treatment-related serious adverse events observed<\/li>\n
- Xerostomia predominantly Grade 1<\/li>\n
- 80% PSA50 response at doses \u2265 160 MBq<\/li>\n
- 100% objective response rate (ORR) in patients with RECIST-measurable lesions, including two complete responses (CRs)<\/li>\n
- The data represent the first clinical trial results for a Lead-212 (212Pb)-based PSMA-targeted radioligand therapy and highlight the potential of 212Pb-ADVC001 to enhance therapeutic options for patients with prostate cancer<\/li>\n
- Phase 2 expansion will evaluate 160 MBq and 200 MBq of 212Pb-ADVC001 using a randomized multi-dose-response design and adaptive dosing strategies to optimize clinical outcomes in three indications: mCRPC (chemo-na\u00efve, and post-177Lu-PSMA) and hormone-sensitive prostate cancer (mHSPC)<\/li>\n<\/ul>\n
Sydney, Australia<\/strong> \u2013 October 18, 2025 \u2013 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today presented results from the Phase 1b dose escalation of the TheraPb Phase 1\/2 clinical trial (NCT05720130<\/a>) at the European Society for Medical Oncology (ESMO) 2025 congress. The presentation featured the first clinical results of 212Pb-ADVC001, a novel Lead-212-based PSMA-targeted alpha therapy in mCRPC.\u00a0<\/p>\n
\u201cWe are very encouraged by the completion of the treatment period of our Phase 1 trial, which has demonstrated a favorable safety profile and compelling anti-tumor activity for 212Pb-ADVC001,”<\/em> said Anna Karmann, MD PhD, Chief Medical Officer of AdvanCell<\/strong>. \u201cThese results underscore the potential of our therapy to meaningfully impact patients\u2019 lives and advance treatment options in metastatic prostate cancer. I want to sincerely thank the investigators, clinical teams, and most importantly the patients and their families, whose commitment has made this important milestone possible.\u201d<\/em><\/p>\n
\u201cThe TheraPb Phase 1 trial of 212Pb-ADVC001 marks a pivotal step forward in the evolution of PSMA-targeted radioligand therapy<\/em>,\u201d said Aaron Hansen, MD, Principal Investigator at Princess Alexandra Hospital<\/strong>. \u201cWe\u2019ve observed a compelling therapeutic index, including marked reductions in tumor volume and PSA, alongside a promising safety and dosimetry profile. The ability to administer alpha therapy easily and efficiently in an outpatient setting is a major clinical advantage. I am excited about the potential of 212Pb-ADVC001 to redefine treatment for patients with prostate cancer.<\/em>\u201d<\/p>\n
Oliver Sartor, MD, Director of the Transformational Prostate Cancer Research Center at East Jefferson General Hospital<\/strong>, remarked, \u201cThe results from this Phase 1 trial demonstrate a strong efficacy signal combined with an excellent safety profile. This is an extremely promising step forward in delivering targeted alpha therapy to patients with prostate cancer<\/em>.\u201d\u00a0<\/p>\n
The abstract submitted to ESMO was based on a data cut-off as of May 9, 2025. The presentation at ESMO includes updated safety and efficacy data from all seven treatment cohorts as of an October 2, 2025 cut-off.<\/p>\n
The TheraPb Phase 1b dose escalation study enrolled 22 patients with mCRPC. Escalating doses of 60\u2013200 MBq of 212Pb-ADVC001 were administered at prespecified schedules every 6, 4, 2 and 1 week(s) for up to six cycles. After cohort 1, six subsequent treatment cohorts were enrolled within ten months.<\/p>\n
TheraPb Phase 1b dose escalation results as of October 2, 2025 cut-off:<\/strong><\/p>\n
Encouraging safety and tolerability<\/strong><\/p>\n
- \n
- No dose-limiting toxicities, treatment-related serious adverse events or treatment-related adverse events leading to dose modification or treatment discontinuation<\/li>\n
- Xerostomia predominantly Grade 1, with evidence of reversibility<\/li>\n<\/ul>\n
Promising anti-tumor activity<\/strong><\/p>\n
- \n
- 80% PSA50 biochemical response at therapeutic doses \u2265 160 MBq<\/li>\n
- 100% ORR in patients with RECIST-measurable lesions, including two CRs<\/li>\n
- PSA, imaging and clinical responses within weeks of treatment start<\/li>\n<\/ul>\n
Favorable dosimetry and kinetics <\/strong><\/p>\n
- \n
- Low normal-organ radiation exposure that supports a dosing strategy beyond six cycles and enhanced dose intensity<\/li>\n
- Fast clearance and no relevant metabolic breakdown<\/li>\n<\/ul>\n
The data represent the first clinical trial results of a 212Pb-based PSMA therapy. The findings support the further development of 212Pb-ADVC001 and may offer a new reference point in the treatment landscape for metastatic prostate cancer, both within and beyond the PSMA-targeted class.<\/p>\n
Phase 2 expansion will evaluate 160 MBq and 200 MBq of 212Pb-ADVC001 using a randomized multi-dose-response design and adaptive dosing strategies to optimize clinical outcomes in three indications: mCRPC (chemo-na\u00efve, and post-177Lu-PSMA) and mHSPC.
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
The poster presentation is available on AdvanCell\u2019s website at: AdvanCell ESMO 2025 Poster<\/a><\/p>\nxxx<\/p>\n
About the TheraPb trial<\/strong><\/p>\n
The TheraPb trial (NCT05720130<\/a>) is a prospective, open-label Phase 1\/2 dose-escalation and expansion study designed to determine the safety and tolerability of escalating doses of 212Pb-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 212Pb-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 212Pb-ADVC001 in PSMA-positive mCRPC and mHSPC.<\/p>\n
About 212Pb-ADVC001<\/strong><\/p>\n
212Pb-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, short half-life (10.6 hours) and simple decay scheme. 212Pb-ADVC001 is designed to deliver radiation at a cellular level to more effectively kill prostate cancer cells while minimizing toxicity.<\/p>\n
About AdvanCell<\/strong><\/p>\n
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 capabilities 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<\/a> and follow us on LinkedIn<\/a>.<\/p>\n
Contacts<\/strong>
Andrew Adamovich, CEO
Anna Karmann, CMO
contact@advancell.com.au<\/a>
<\/a>
For media inquiries, please contact:<\/strong>
MEDiSTRAVA (in the UK)
Mark Swallow, Frazer Hall, Sylvie Berrebi
advancell@medistrava.com<\/a>
+44 (0)20 3928 6700<\/p>\n![\"\"](\"https:\/\/ml-eu.globenewswire.com\/media\/MTY3N2NkNTItY2RhOS00MTU0LWFhNDYtNDM4ZDBiY2I3MjUyLTcwMDAyNjU1Ni0yMDI1LTEwLTE4LWVu\/tiny\/AdvanCell.png\")
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