Advancell Isotopes Pty Ltd. is an Australian radiopharmaceutical company that specializes in developing innovative Targeted Alpha Therapies for cancer patients. The company utilizes a unique platform technology that addresses the challenges associated with the supply of isotopes, which is a critical aspect of targeted alpha therapy. AdvanCell's drug discovery, preclinical processes, and advanced facilities enable daily access to 212Pb, the ideal isotope for this type of therapy.

Tags

Neoplasms

Urogenital Diseases

Skin and Musculoskeletal Diseases

Therapeutic radiopharmaceuticals

Chemical drugs

Radiopharmaceuticals and diagnostic agent

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	8
Endocrinology and Metabolic Disease	2

Top 5 Drug Type	Count

Therapeutic radiopharmaceuticals	4
Chemical drugs	3
Radiopharmaceuticals and diagnostic agent	1

Top 5 Target	Count

PSMA(Prostate-specific membrane antigen)	2

Drugs associated with AdvanCell Isotopes Pty Ltd.

[212Pb]Pb-ADVC001

Target

PSMA

Mechanism

PSMA inhibitors [+1]

Active Org.

AdvanCell Isotopes Pty Ltd.

Originator Org.

AdvanCell Isotopes Pty Ltd.

Active Indication

Metastatic castration-resistant prostate cancer

Inactive Indication-

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

[212Pb]Pb-ADVC002

Target-

Mechanism

Ionising radiation emitters

Active Org.

AdvanCell Isotopes Pty Ltd.

Originator Org.

AdvanCell Isotopes Pty Ltd.

Active Indication

Melanoma

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

ADVC005

Target-

Mechanism-

Active Org.

AdvanCell Isotopes Pty Ltd.

Originator Org.

AdvanCell Isotopes Pty Ltd.

Active Indication

Prostatic Cancer

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with AdvanCell Isotopes Pty Ltd.

ACTRN12622001378718

/ RecruitingPhase 1/2

Phase I/IIa Dose Escalation and Toxicity Study of [212Pb]Pb-ADVC001 in Metastatic Prostate Adenocarcinoma (TheraPb – Phase I/II)

Start Date01 Nov 2023

Sponsor / Collaborator

AdvanCell Isotopes Pty Ltd.

NCT05720130

/ RecruitingPhase 1/2

Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Castration Resistant Prostate Cancer (TheraPb - Phase I/II Study).

This is a prospective, open-label, non-randomised, dose-escalation and expansion study. The study aims to determine the safety and tolerability of escalating doses of [²¹²Pb]Pb-ADVC001 administered every 4 or every 2 weeks during the dose finding phase (Phase 1b), and then aims to assess the efficacy and safety of [²¹²Pb]Pb-ADVC001 at the RP2D in 3 participant groups in the expansion phase (Phase 2a).

Start Date15 Mar 2023

Sponsor / Collaborator

AdvanCell Isotopes Pty Ltd.

100 Clinical Results associated with AdvanCell Isotopes Pty Ltd.

0 Patents (Medical) associated with AdvanCell Isotopes Pty Ltd.

Literatures (Medical) associated with AdvanCell Isotopes Pty Ltd.

21 Apr 2025·Cancer Research

Abstract 588: Preclinical evaluation of a novel 212Pb-based, PSMA-targeted radioligand, 212Pb-ADVC001, for prostate cancer treatment

Author: Shakti, Stelle ; Liu, Feifei ; Kumar, Saawan ; Kryza, Thomas ; Koehbach, Johannes ; Li, Gary ; Horsfall, Aimee ; Puttick, Simon ; Rose, Stephen ; Li, Kwong Ching ; Tieu, William ; Kuan, Kevin ; Monterosso, Melissa E. ; Boucher, Didier ; Karmann, Anna

AbstractIntroduction:PSMA-targeted radioligand therapy (RLT) with lutetium-177 (177Lu), a beta-emitter, has been clinically proven to be efficacious for the treatment of prostate cancer (PC). Although emerging clinical data indicate that better efficacy can be achieved by alpha-emitters, the toxicities associated with actinium-225 (225Ac) may limit its broad application especially in early lines of treatment. Lead-212 (212Pb), is a promising isotope for alpha therapy with a high linear energy transfer, a half-life of 10.6 hours, and a simple decay scheme. These properties promote efficient targeting of PSMA+ PC cells while limiting off-target toxicities. Pb-ADVC001 is a novel Pb-based PSMA-targeted RLT currently in Phase Ib/IIa clinical trial (NCT05720130) for patients with metastatic castration-resistant prostate cancer (mCRPC).Methods:The affinity of ADVC001 and Pb-ADVC001 to PSMA was determined by SPR and radioligand-binding assays in PSMA+ PC cell lines. Cytotoxic activity was measured by cell viability and clonogenic assays. In vivo biodistribution and anti-tumor efficacy studies were performed in human-derived PC-bearing mice. The intrinsic molecular and cellular mechanisms associated with Pb-ADVC001 mediated cell-death were assessed using transcriptomics and proteomics.Results:ADVC001 binds human, mouse and rat PSMA with comparable nanomolar activities, and efficiently internalizes upon binding to PSMA+ PC cells. In vitro, Pb-ADVC001 showed specific and potent cytotoxic activity against multiple PSMA+ human PC cell lines, while sparing PSMA- cells. In vivo biodistribution of Pb-ADVC001 showed tumor uptake at 19.6, 20.9, 9.4 and 5.4 %ID/g at 1, 3, 24 and 48 h, respectively, with retention out to 72 h. High tumor uptake and fast renal clearance resulted in favorable tumor/kidney ratios. Minimal uptake was observed in other normal tissues. Single administration of Pb-ADVC001 in PSMA+ PC xenografts led to dose-dependent anti-tumor response and significant survival benefit. Transcriptomic analysis of in vitro treated PC cells and proteomic analysis of tumors harvested longitudinally revealed multiple mechanisms of action involving DNA damage, cell cycle arrest and cell death, and immune response modulation.Conclusion:Preclinical data demonstrated the potential of Pb-ADVC001 for the treatment of patients with PSMA+ prostate cancer. Transcriptomic and proteomic analyses indicate multiple mechanisms of action collectively resulting in effective cancer therapy.Citation Format:Melissa E. Monterosso, Feifei Liu, Didier Boucher, Stelle Shakti, Kwong Ching Li, Aimee Horsfall, Saawan Kumar, Johannes Koehbach, Kevin Kuan, William Tieu, Stephen Rose, Anna Karmann, Gary Li, Simon Puttick, Thomas Kryza. Preclinical evaluation of a novel Pb-based, PSMA-targeted radioligand, Pb-ADVC001, for prostate cancer treatment [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 588.

21 Apr 2025·Cancer Research

Abstract 1333: Uncovering the mechanisms of action of 177Lu- and 212Pb- based PSMA radioligand therapies

Author: Kryza, Thomas ; Shakti, Stelle ; Kumar, Saawan ; Koehbach, Johannes ; Horsfall, Aimee ; Puttick, Simon ; Rose, Stephen ; Li, Gary ; Li, Kwong Ching ; Tieu, William ; Kuan, Kevin ; Boucher, Didier ; Karmann, Anna ; Liu, Feifei ; Monterosso, Melissa E.

AbstractIntroduction:177Lu-PSMA-617 is the first FDA-approved targeted radioligand therapy (RLT), and in clinical trials, significantly prolonged survival and improved quality of life in patients with metastatic castration resistant prostate cancer (mCRPC). However, approximately 30% of the patients do not respond to the treatment and most initial responders ultimately relapse. Compared to the beta-emitter 177Lu, the alpha therapy isotope 212Pb may prove to be advantageous due to its short half-life, high linear energy transfer, and efficient induction of immunogenic cell death. Here we used in vitro and in vivo models to elucidate the intrinsic cellular mechanisms of response to 177Lu-PSMA and 212Pb-PSMA treatment.Methods:177Lu-PSMA-I&T and 212Pb-ADVC001 were used as PSMA-targeted 177Lu- and 212Pb-RLT, respectively. The cytotoxic activity in prostate cancer (PC) cell lines was measured by a cell viability assay. In vivo studies were performed in human PC-bearing mice to compare preclinical efficacy of 177Lu- and 212Pb-PSMA therapy. The kinetic mechanisms associated with 177Lu-PSMA-I&T and 212Pb-ADVC001 mediated cell-death were assessed ex vivo using proteomics, and their impact on the PC cell cycle by flow cytometry.Results:212Pb-ADVC001 displayed potent cytotoxic activity with an average EC50 of 2.7, 7.2 and 3.3 kBq/mL in PC cell lines PC-3-PIP (PSMAhigh), C4-2 (PSMAint) and LNCaP (PSMAint), respectively, compared to 177Lu-PSMA-I&T (430.7, 434.9 and 814.4 kBq/mL, respectively). In PSMAhigh xenograft models, 212Pb-ADVC001 (0.43 MBq) significantly improved median survival to 84 days compared to 48 days for 177Lu-PSMA I&T (20 MBq). Multidose efficacy studies demonstrated superior tumor response with two cycles of 212Pb-ADVC001 (0.46 MBq) compared to two cycles of 177Lu-PSMA I&T (15 MBq). 212Pb-ADVC001 administration in 177Lu-PSMA I&T-relapsed mice resulted in improved survival. In PSMAint xenograft models, 212Pb-ADVC001 (0.9 MBq) also suppressed tumor progression more effectively than 177Lu-PSMA-I&T (30 MBq), resulting in prolonged survival. Proteomics analysis of RLT-treated tumors revealed a specific impact of 212Pb-ADVC001 on cell cycle checkpoints and DNA replication. In vitro cell cycle experiment further confirmed that 212Pb-ADVC001 caused significant DNA damage, and reduced DNA content in the S-phase of the cell cycle with a concomitant increase in the G1 and G2/M-phase arrest compared to 177Lu-PSMA-I&T (p<0.05).Conclusion:Comparison studies of 177Lu- and 212Pb-PSMA treatment on PC cells showed a higher efficacy of 212Pb-PSMA in vitro and in vivo supporting the clinical application of 212Pb-PSMA for mCRPC. Mechanistic studies furthered the understanding of PC radiobiology and cellular responses to beta- and alpha-RLT with the identification of a cell cycle arrest in PC specifically induced by 212Pb-PSMA.Citation Format:Feifei Liu, Melissa E. Monterosso, Didier Boucher, Stelle Shakti, Kwong Ching Li, Aimee Horsfall, Saawan Kumar, Johannes Koehbach, Kevin Kuan, William Tieu, Stephen Rose, Anna Karmann, Simon Puttick, Gary Li, Thomas Kryza. Uncovering the mechanisms of action of 177Lu- and 212Pb- based PSMA radioligand therapies [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 1333.

08 Sep 2023·Neuro-Oncology

P15.02.A EVALUATION OF [68GA]GA-PSMA-617 PET AS A DIAGNOSTIC AGENT IN RECURRENT GLIOBLASTOMA PATIENTS: RESULTS OF THE GENESIS GBM 001 PHASE I/II STUDY

Author: Sproule, V ; Tooney, P ; Fay, M ; Waddington, D ; Keall, P ; Brighi, C ; Woods, A ; Puttick, S

AbstractBACKGROUNDPSMA is a cell-surface protein that is highly expressed in the endothelium of the tumour neovasculature of several solid tumours, including glioblastoma (GBM), making it an excellent target for antibody-drug conjugates or peptide receptor radionuclide therapy. Several [68Ga]Ga-PSMA-based radioligands have shown utility in the diagnosis and treatment response assessment of primary GBM patients in a number of case studies. The small-molecule ligand [68Ga]Ga-PSMA-617 has the advantage of being suitable for radiolabelling with different radioisotopes, including 68Ga, 177Lu, 111In and 90Y, which raised the possibility of using it in a theranostic application in glioblastoma. The aim of this phase I/II prospective study was to evaluate the potential of [68Ga]Ga-PSMA-617 as a PET imaging biomarker and as a candidate ligand for targeted radionuclide therapy in patients with recurrent GBM.MATERIAL AND METHODSTen patients with recurrent glioblastoma were recruited for the study between October 2018 and September 2021. Patients underwent [68Ga]Ga-PSMA-617 and [18F]F-FET PET brain scans done on two separate days. Two patients had full-body [68Ga]Ga-PSMA-617 scans. Tumour selectivity of [68Ga]Ga-PSMA-617 was assessed by measuring tumour volume on [68Ga]Ga-PSMA-617 PET scans and comparing it with tumour volume measured on [18F]F-FET PET scans, which are more widely used clinically. Tumour specificity of [68Ga]Ga-PSMA-617 was assessed by comparing its standard uptake value (SUV) and tumour-to-brain-ratio (TBR) with those of [18F]F-FET TBR, and by measuring [68Ga]Ga-PSMA-617 tumour-to-liver ratio (TLR).RESULTSPSMA-defined tumour volume was on average 1.87±1.10 times larger than the FET-defined tumour volume (p=0.084), and the two volumes had a DICE similarity coefficient of 0.578±0.175. Mean and maximum TBR was significantly (p=0.002) higher (~10x) for PSMA than for FET. Mean SUV in the tumour was significantly higher for FET than for PSMA (p=0.002), while maximum SUV was slightly higher for PSMA than for FET (p=0.08). For the two patients with full-body [68Ga]Ga-PSMA PET scan available, PSMA mean TLR was 0.91 and 0.68, and maximum TLR was 1.20 and 1.07, respectively.CONCLUSION[68Ga] Ga-PSMA PET delineates a larger tumour volumes compared to [18F]F-FET PET, suggesting there are areas of the tumour with emerging tumour neovasculature that are not yet metabolically active. The poor spatial overlap between PSMA and FET tumour volume suggests the complementary diagnostic role of the two tracers. The higher TBR of PSMA compared to FET demonstrates the higher tumour specificity of the former, and thus its potential ability as a diagnostic agent for recurrent tumour volume delineation. Relatively low values of PSMA SUV and TLR suggest that PSMA specific uptake is not sufficient to use this ligand for targeted radionuclide therapy in glioblastoma when conjugated to [177Lu].

100 Deals associated with AdvanCell Isotopes Pty Ltd.

100 Translational Medicine associated with AdvanCell Isotopes Pty Ltd.

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Drug(Targets)	Indications	Global Highest Phase

[212Pb]Pb-ADVC001 ( PSMA )	Metastatic castration-resistant prostate cancer More	Phase 2 Clinical
ADVC005	Prostatic Cancer More	Preclinical
ADVC007	Lung Cancer More	Preclinical
[212Pb]Pb-ADVC002	Melanoma More	Preclinical
[212Pb]Pb-ADVC003	Breast Cancer More	Preclinical

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