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    DRUG:

    AAA614

    i
    Other names: 3B201, 3B 201, AAA-614, AAA 614, FAP2286, AAA614, 177Lu-FAP-2286, FAP 2286, 3B-201, FAP-2286
    Company:
    3B Pharma, Clovis, Novartis
    Drug class:
    Ionizing radiation emitter, FAP inhibitor
    Related drugs:
    2ms
    Preclinical Evaluation of 177Lu-OncoFAP-23, a Multivalent FAP-Targeted Radiopharmaceutical Therapeutic for Solid Tumors. (PubMed, J Nucl Med)
    177Lu-OncoFAP and 177Lu-FAP-2286 were included in the biodistribution study as controls. OncoFAP-23 presents enhanced tumor uptake and tumor retention and low accumulation in healthy organs, findings that correspond to a strongly improved in vivo antitumor efficacy. The data presented in this work support the clinical development of 177Lu-OncoFAP-23 for the treatment of FAP-positive solid tumors.
    Preclinical • Journal
    |
    FAP (Fibroblast activation protein, alpha)
    |
    AAA614
    3ms
    A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE) (clinicaltrials.gov)
    P1/2, N=222, Recruiting, Novartis Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    FAP (Fibroblast activation protein, alpha)
    |
    AAA614
    10ms
    A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE) (clinicaltrials.gov)
    P1/2, N=222, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FAP (Fibroblast activation protein, alpha)
    |
    FAP expression
    |
    AAA614
    over1year
    A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE) (clinicaltrials.gov)
    P1/2, N=300, Recruiting, Clovis Oncology, Inc. | N=170 --> 300
    Enrollment change • Metastases
    |
    FAP expression
    |
    AAA614
    over1year
    Fibroblast activation protein (FAP)-targeted radiotherapy increases tumor CD8+ T cell infiltration and enhances response to PD-1 immune checkpoint blockade (AACR 2023)
    FAP-targeted radiopharmaceutical enhances PD-1-antibody-mediated TGI by increasing recruitment of tumor-infiltrating CD8+ T cells, which is enhanced and maintained in the presence of anti-PD-1. These findings provide a rationale for clinical studies of combined 177Lu-FAP-2286 radiotherapy and immune checkpoint blockade in FAP-positive tumors.
    Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker • Checkpoint block
    |
    CD8 (cluster of differentiation 8) • FAP (Fibroblast activation protein, alpha) • CD86 (CD86 Molecule)
    |
    FAP expression
    |
    AAA614
    over3years
    Feasibility, Biodistribution and Preliminary Dosimetry in Peptide-Targeted Radionuclide Therapy (PTRT) of Diverse Adenocarcinomas using Lu-FAP-2286: First-in-Human Results. (PubMed, J Nucl Med)
    Lu-FAP-2286 PTRT, applied in a broad spectrum of cancers, was relatively well-tolerated with acceptable side effects and demonstrated long retention of the radiopeptide. Prospective clinical studies are warranted.
    P1 data • Journal
    |
    FAP (Fibroblast activation protein, alpha)
    |
    AAA614
    over4years
    [VIRTUAL] Preclinical evaluation of FAP-2286, a peptide-targeted radionuclide therapy (PTRT) to fibroblast activation protein alpha (FAP) (ESMO 2020)
    Legal entity responsible for the study: Clovis Oncology, Inc., 3B Pharmaceuticals GmbH. Funding: Clovis Oncology, Inc., 3B Pharmaceuticals GmbH.
    Preclinical
    |
    FAP (Fibroblast activation protein, alpha)
    |
    FAP expression
    |
    AAA614