AdvanCell’s 212Pb-ADVC001 demonstrates encouraging security and compelling anti-tumor exercise in Part 1b in prostate most cancers

• Outcomes from the TheraPb Part 1b dose escalation offered at ESMO 2025 present a promising therapeutic index for 212Pb-ADVC001 in sufferers with metastatic castration-resistant prostate most cancers (mCRPC)
• No dose-limiting toxicities and no treatment-related severe antagonistic occasions noticed
• Xerostomia predominantly Grade 1
• 80% PSA50 response at doses ≥ 160 MBq
• 100% goal response price (ORR) in sufferers with RECIST-measurable lesions, together with two full responses (CRs)
• The info signify the primary scientific trial outcomes for a Lead-212 (212Pb)-based PSMA-targeted radioligand remedy and spotlight the potential of 212Pb-ADVC001 to boost therapeutic choices for sufferers with prostate most cancers
• Part 2 enlargement will consider 160 MBq and 200 MBq of 212Pb-ADVC001 utilizing a randomized multi-dose-response design and adaptive dosing methods to optimize scientific outcomes in three indications: mCRPC (chemo-naïve, and post-177Lu-PSMA) and hormone-sensitive prostate most cancers (mHSPC)

SYDNEY — AdvanCell, a clinical-stage radiopharmaceutical firm growing progressive focused alpha therapies for most cancers, offered outcomes from the Part 1b dose escalation of the TheraPb Part 1/2 scientific trial ( NCT05720130) on the European Society for Medical Oncology (ESMO) 2025 congress. The presentation featured the primary scientific outcomes of 212Pb-ADVC001, a novel Lead-212-based PSMA-targeted alpha remedy in mCRPC.

The summary submitted to ESMO was based mostly on an information cut-off as of Might 9, 2025. The presentation at ESMO contains up to date security and efficacy knowledge from all seven therapy cohorts as of an October 2, 2025 cut-off.

The TheraPb Part 1b dose escalation examine enrolled 22 sufferers with mCRPC. Escalating doses of 60–200 MBq of 212Pb-ADVC001 have been administered at prespecified schedules each 6, 4, 2 and 1 week(s) for as much as six cycles. After cohort 1, six subsequent therapy cohorts have been enrolled inside ten months.

• No dose-limiting toxicities, treatment-related severe antagonistic occasions or treatment-related antagonistic occasions resulting in dose modification or therapy discontinuation
• Xerostomia predominantly Grade 1, with proof of reversibility

• 80% PSA50 biochemical response at therapeutic doses ≥ 160 MBq
• 100% ORR in sufferers with RECIST-measurable lesions, together with two CRs
• PSA, imaging and scientific responses inside weeks of therapy begin

• Low normal-organ radiation publicity that helps a dosing technique past six cycles and enhanced dose depth
• Quick clearance and no related metabolic breakdown

The info signify the primary scientific trial outcomes of a 212Pb-based PSMA remedy. The findings assist the additional growth of 212Pb-ADVC001 and should provide a brand new reference level within the therapy panorama for metastatic prostate most cancers, each inside and past the PSMA-targeted class.

Part 2 enlargement will consider 160 MBq and 200 MBq of 212Pb-ADVC001 utilizing a randomized multi-dose-response design and adaptive dosing methods to optimize scientific outcomes in three indications: mCRPC (chemo-naïve, and post-177Lu-PSMA) and mHSPC.

The poster presentation is out there on AdvanCell’s web site at: AdvanCell ESMO 2025 Poster xxx

The TheraPb trial ( NCT05720130) is a potential, open-label Part 1/2 dose-escalation and enlargement examine designed to find out the security and tolerability of escalating doses of 212Pb-ADVC001 administered each 6, 4, 2 or 1 week(s) through the dose discovering Part 1b. The Part 2 enlargement will assess the efficacy and security of 212Pb-ADVC001 on the really helpful Part 2 doses throughout three indications. The trial makes use of a randomized dose-response design and dose optimization parts to carefully consider optimum dosing methods of 212Pb-ADVC001 in PSMA-positive mCRPC and mHSPC.

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 excessive dose price, brief half-life (10.6 hours) and easy decay scheme. 212Pb-ADVC001 is designed to ship radiation at a mobile degree to extra successfully kill prostate most cancers cells whereas minimizing toxicity.