FB3001 / Frontier Biotech - LARVOL DELTA

ARTISAN: Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: ARTBIO Inc. | Trial completion date: Sep 2033 ➔ Nov 2028

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Cytotoxicity and cell cycle changes in prostate cancer cells with differing PSMA expression and p53 status after treatment with PSMA-targeting radioligand [212Pb]Pb-AB001. (PubMed, Sci Rep) - "Total cell-bound activity, rather than added activity, better predicted radiotoxicity in both TP53-wild-type and TP53-null cell lines, indicating that its therapeutic effect is primarily governed by PSMA-mediated uptake rather than p53 status. These results support the therapeutic potential of [212Pb]Pb-AB001 across cells with varying TP53 status and suggest that combining [212Pb]Pb-AB001 with DNA repair or checkpoint inhibitors may enhance treatment efficacy."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1 • TP53

ARTISAN: Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: ARTBIO Inc. | Trial primary completion date: Sep 2033 ➔ Nov 2027

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ARTISAN: Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: ARTBIO Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ARTISAN: Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: ARTBIO Inc.

New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Beyond PSMA Targeting: What Truly Drives the Radiotoxicity of the Alpha-Emitting [ 212 Pb]Pb-AB001? (EANM 2025) - "The findings of the study underscore the need for precise microdosimetry and spatially relevant tumor models as well as evaluation of genetic complexity to optimize targeted alpha therapies. Combination strategies involving [ 212 Pb]Pb-AB001 and agents targeting DNA repair pathways, cell cycle modulation or senescent cells may enhance therapeutic efficacy."

Genito-urinary Cancer • Prostate Cancer • Solid Tumor • ANXA5 • FOLH1

Optimizing [212Pb]Pb-AB001 Radiopharmaceutical Therapy Schedules in PSMA-Positive Subcutaneous Prostate Cancer Xenografts. (PubMed, J Nucl Med) - " The efficacy of [212Pb]Pb-AB001 radiopharmaceutical therapy depended on cycle number, interval, and per-cycle activity. Multicycle regimens enhanced tumor control without toxicity, supporting schedule optimization in clinical protocols for [212Pb]Pb-PSMA therapy."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Combination of PSMA targeting alpha-emitting radioligand [212Pb]Pb-AB001 with BET bromodomain inhibitors in in vitro prostate cancer models. (PubMed, Med Oncol) - "Bromodomain and extra-terminal (BET) protein inhibitors, such as AZD5153 and JQ1, disrupt oncogenic transcriptional programs by altering chromatin structure. In 3D spheroids, combination treatment led to synergistic growth suppression. In conclusion, these findings indicate that therapeutic inhibition of BET bromodomain in combination with the alpha-emitting radioligand [212Pb]Pb-AB001 could significantly enhance tumour control and should be further evaluated in metastatic prostate cancer models."

Journal • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Therapeutic evaluation of [212Pb]Pb-AB001 and [177Lu]Lu-PSMA-617 in a mouse model of disseminated prostate cancer. (PubMed, Eur J Nucl Med Mol Imaging) - "[212Pb]Pb-AB001 showed significant efficacy against micrometastases and advantages over [177Lu]Lu-PSMA-617 in preventing or treating early bone metastases for the investigated injected activities. This implies clinical potential for treating mCRPC, including patients at risk of early metastatic disease, but further studies including dosimetry and toxicity analyses are required with regards to activity levels."

Journal • Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

INTERIM RESULTS FROM THE PHASE I IBC -01-01 STUDY: THE FIRST IMMUNE CHECKPOINT INHIBITOR THERAPY IN PATIENTS WITH EARLY ALZHEIMER'S DISEASE (ADPD 2025) - "IBC -01-01 is a Phase I clinical study investigating the safety, tolerability, and preliminary efficacy of IBC -Ab001, a no vel immunomodulatory agent designed to harness peripheral immunity by targeting the inhibitory immune checkpoint PD -L1 in patients with early AD. IBC-01-01 adopts an innovative approach in AD treatment by targeting an immune checkpoint inhibitor for the fir st time in dementia therapy. This first -of-its-kind treatment represents a unique approach to targeting AD by leveraging the physiological role of the immune system in brain repair."

Checkpoint inhibition • Clinical • IO biomarker • P1 data • Alzheimer's Disease • CNS Disorders • Dementia • Inflammation • Oncology • APOE

First-in-Human Phase 0 Study of AB001, a Prostate-Specific Membrane Antigen-Targeted 212Pb Radioligand, in Patients with Metastatic Castration-Resistant Prostate Cancer. (PubMed, J Nucl Med) - "γ-camera imaging of AB001 was feasible, even at a microdose, and demonstrated metastatic targeting, albeit for only 1 lesion. The promising biodistribution and clearance encourage further clinical investigation."

Journal • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

First-in-human study of Phase 0 experience (EMUC 2024) - "A theragnostic microdose phase 0 clinical trial of AB001 (formerly 212 Pb-NG001), a PSMA targeting small molecule labeled with the in vivo generating alpha-emitter 212 Pb, was conducted at Oslo University Hospital. Conclusions The 212 Pb alpha radioligand AB001 was safely administered to mCRPC patients in this microdose study. Gamma camera imaging was shown to be feasible, and provided proof of metastatic targeting for AB001, which combined with promising biodistribution and clearance warrant further clinical investigation."

P1 data • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • FOLH1

AB001. Development of tumour-targeted therapy for the treatment of adult and paediatric high-grade gliomas. (PubMed, Chin Clin Oncol) - "The results obtained from this work serve as proof of principle that enables tumour-specific drug delivery to treat HGG. This work also paves the way for treating other brain cancers and central nervous system (CNS) disorders like Parkinson's and Alzheimer's disease, for which no adequate therapy exists."

Journal • Review • Alzheimer's Disease • Brain Cancer • CNS Disorders • CNS Tumor • Glioblastoma • Glioma • Movement Disorders • Oncology • Parkinson's Disease • Pediatrics • Solid Tumor

Evaluating probiotic efficacy on weight loss in adults with overweight through a double-blind, placebo-controlled randomized trial. (PubMed, Sci Rep) - P=N/A | "However, in the double blinded phase, no differences between groups were found. The probiotic compound AB001 was well tolerated and can safely be used up to double dose for 90 days followed by triple dose for 90 days.Trial registration: Clinicaltrial.gov NCT04897698, registered on 21 May 2021."

Journal • Obesity

Characterization of atypical pathogenic Aeromonas salmonicida isolated from a diseased Siberian sturgeon (Acipenser baerii). (PubMed, Heliyon) - "Antibiotic sensitivity testing showed that the strain is sensitive to aminoglycosides, amphenicols, nitrofurans, quinolones, and tetracyclines. Half-lethal doses (LD) of strain AB001 for Oreochromis mossambicus and A. baerii were determined: respectively 1.7 × 10 and 7.2 × 10 colony-forming units per mL. The experimentally induced infection revealed that strain AB001 causes considerable histological lesions in O. mossambicus, including tissue degeneration, necrosis, and hemorrhages of varied severity."

Journal • Hematological Disorders • Infectious Disease

Impact of a Single Dose of a Probiotic Nutritional Supplement (AB001) on Absorption of Ethylalcohol: Results From a Randomized Double-Blind Crossover Study. (PubMed, Nutr Metab Insights) - "The supplement uptake was well tolerated and there were no adverse events related to the study intervention. Uptake of a single dose of AB001 shortly before drinking alcohol significantly reduced plasma alcohol and breath alcohol concentrations, but the effect was less pronounced compared to chronic uptake as shown previously."

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Chronic Uptake of A Probiotic Nutritional Supplement (AB001) Inhibits Absorption of Ethylalcohol in the Intestine Tract - Results from a Randomized Double-blind Crossover Study. (PubMed, Nutr Metab Insights) - "One week of supplementation with AB001 resulted in a substantially reduced absorption of alcohol into the body. Regular uptake of AB001 may help to prevent liver and other organ damage, and may reduce the negative medical and economical impact of social drinking on the individual and the society."

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Dual mechanisms of novel CD73-targeted antibody and antibody-drug conjugate in inhibiting lung tumor growth and promoting antitumor immune-effector function. (PubMed, Mol Cancer Ther) - "We developed two novel series of CD73 antibody Ab001/Ab002 and humanized version Hu001/Hu0002, which demonstrated high CD73 binding affinity, potent enzyme inhibition and efficiently protected effector T lymphocyte function from adenosine/cancer-imposed toxicity. Studies with human PBMC-derived systems confirmed CD73-ADC as fully functional in protecting effector T cells and stimulating DCs thus providing dual benefits in killing CD73-high tumors and improving cancer immunity response. These results warrant clinical investigation of CD73-targeted antibody and ADC for treating advanced lung cancer."

IO Biomarker • Journal • Glioma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CD73 • EGFR • EML4

Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects (clinicaltrials.gov) - P1; N=34; Completed; Sponsor: Frontier Biotechnologies Inc.; Recruiting ➔ Completed

Clinical • Trial completion

Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects (clinicaltrials.gov) - P1; N=34; Recruiting; Sponsor: Frontier Biotechnologies Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects (clinicaltrials.gov) - P1; N=34; Not yet recruiting; Sponsor: Frontier Biotechnologies Inc.

Clinical • New P1 trial

Transcriptomic analysis reveals that enterovirus F strain SWUN-AB001 infection activates JNK/SAPK and p38 MAPK signaling pathways in MDBK cells. (PubMed, BMC Vet Res) - "Our transcriptome analysis provides useful initial data towards better understanding of the infection mechanisms used by EV-F7, while highlighting the potential molecular relationships occurring between the virus and the host's cellular components."

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