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    DRUG:

    ELU001

    i
    Other names: ELU001, ELU 001, EC112002, ELU-001, FA-CDC, exatecan CDCs, folate receptor alpha targeting exatecan CDCs
    Company:
    Elucida Oncology
    Drug class:
    Topoisomerase I inhibitor, Folate receptor 1-targeted small molecule-drug conjugate
    Related drugs:
    3ms
    Pediatric AML: ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML (clinicaltrials.gov)
    P1, N=0, Withdrawn, Elucida Oncology | Trial completion date: Apr 2026 --> Jun 2024 | Trial primary completion date: Sep 2025 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    CBFA2T3 (CBFA2/RUNX1 Partner Transcriptional Co-Repressor 3) • GLIS2 (GLIS Family Zinc Finger 2)
    |
    ELU001
    4ms
    ELU-FRα-1: A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) (clinicaltrials.gov)
    P1/2, N=79, Terminated, Elucida Oncology | Trial completion date: Sep 2024 --> Jun 2024 | Active, not recruiting --> Terminated; Lack of Funding - no safety issue with Drug; Company Bankruptcy
    Trial completion date • Trial termination • Metastases
    |
    FOLR1 ( Folate receptor alpha )
    |
    ELU001
    5ms
    ELU-FRα-1: A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) (clinicaltrials.gov)
    P1/2, N=79, Active, not recruiting, Elucida Oncology | Recruiting --> Active, not recruiting | N=166 --> 79 | Trial completion date: Jun 2025 --> Sep 2024
    Enrollment closed • Enrollment change • Trial completion date • Metastases
    |
    FOLR1 ( Folate receptor alpha )
    |
    ELU001
    7ms
    Study of ELU001, a C'Dot drug conjugate (CDC) targeting folate receptor α (FRα) overexpressing solid tumors. (ASCO 2024)
    Oncol. (2023) 34 (suppl_2): S458-S497.
    FOLR1 ( Folate receptor alpha )
    |
    VENTANA FOLR1 RxDx Assay
    |
    ELU001
    12ms
    Pediatric AML: ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML (clinicaltrials.gov)
    P1, N=0, Withdrawn, Elucida Oncology | N=21 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    CBFA2T3 (CBFA2/RUNX1 Partner Transcriptional Co-Repressor 3) • GLIS2 (GLIS Family Zinc Finger 2)
    |
    ELU001
    over1year
    ELU-FRα-1: A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) (clinicaltrials.gov)
    P1/2, N=166, Recruiting, Elucida Oncology | Trial completion date: Mar 2025 --> Jun 2025 | Trial primary completion date: Mar 2024 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    FOLR1 ( Folate receptor alpha )
    |
    ELU001
    over1year
    First-in-human study of ELU001, a targeted nanoparticle drug conjugate, in subjects with folate receptor α (FRα) overexpressing solid tumors (ESMO 2023)
    The Q2W regimen had a better hematological safety profile with no related discontinuations. Conclusions Safety and efficacy of ELU001 demonstrated expected, manageable safety profile based on the payload, exatecan, with promising activity in heavily pretreated patients across several cancer indications with low, moderate or high FRα expression.
    Clinical • P1 data
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    ELU001
    over1year
    Phase 1 trial of a novel C’Dot drug conjugate (CDC), ELU001, in patients with solid tumors known to overexpress folate receptor alpha (FRα). (ASCO 2023)
    The study is enrolling in Part 1 Q2W Cohort 301 and Q3W Cohort A in the US. Clinical trial information: NCT05001282.
    Clinical • P1 data
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    ELU001
    over1year
    ELU-FRα-1: a study to evaluate ELU001 in patients with solid tumors that overexpress folate receptor alpha (FRα) (AACR 2023)
    The study is actively enrolling in the US and currently recruiting in Q2W Cohort 201 and Q3W Cohort A. QW Cohorts 1-3 and Q2W Cohort 101 are complete. Clinical trial information: NCT05001282.
    Clinical
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    ELU001
    over1year
    Preclinical development of ELU001: A folate receptor alpha (FRα)-targeted C’Dot drug conjugate (CDC) for the treatment of brain metastases (AACR 2023)
    Retreatment of these animals resulted in an additional decrease in tumor burden. These results suggest that ELU001 may have promise for the treatment of metastatic brain tumors that are difficult to treat with currently available agents.
    Preclinical
    |
    FOLR1 ( Folate receptor alpha )
    |
    ELU001
    2years
    Pediatric AML: ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML (clinicaltrials.gov)
    P1, N=21, Not yet recruiting, Elucida Oncology
    New P1 trial
    |
    CBFA2T3 (CBFA2/RUNX1 Partner Transcriptional Co-Repressor 3) • GLIS2 (GLIS Family Zinc Finger 2)
    |
    ELU001
    2years
    Ultrasmall Folate Receptor Alpha Targeted Enzymatically Cleavable Silica Nanoparticle Drug Conjugates Augment Penetration and Therapeutic Efficacy in Models of Cancer. (PubMed, ACS Nano)
    When compared with an anti-FRα-DM4 ADC, EC112002 demonstrated deeper penetration into 3D cell-line-derived tumor spheroids and superior specific cytotoxicity in a panel of 3D patient-derived tumor spheroids, as well as enhanced efficacy in cell-line-derived and patient-derived in vivo tumor xenograft models expressing a range of low to high levels of FRα. With the growing interest in developing clinically translatable, safe, and efficacious DDSs, EC112002 has the potential to address some of the critical limitations of the current systemic drug delivery for cancer management.
    Journal
    |
    FOLR1 ( Folate receptor alpha )
    |
    ELU001
    over2years
    ELU-FRα-1: A study to evaluate ELU001 in patients with solid tumors that overexpress folate receptor alpha (FRα). (ASCO 2022)
    The study is actively enrolling in the US – Cohorts 1-2 have been completed without DLT. Enrollment to Cohort 3 began in December 2021.
    Clinical
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    ELU001
    over2years
    Stability and safety evaluation of ELU001, a targeted C’Dot drug conjugate for the potential treatment of folate receptor alpha-overexpressing cancers (AACR 2022)
    No ELU001 anti-drug antibodies were induced in either species. In summary, ELU001 has a favorable nonclinical safety/TK profile and is currently under evaluation in a clinical safety study - NCT05001282.
    Clinical
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 overexpression
    |
    ELU001
    3years
    A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) (clinicaltrials.gov)
    P1/2, N=166, Recruiting, Elucida Oncology | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    FOLR1 ( Folate receptor alpha )
    |
    ELU001
    over3years
    A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) (clinicaltrials.gov)
    P1/2, N=166, Not yet recruiting, Elucida Oncology
    Clinical • New P1/2 trial
    |
    FOLR1 ( Folate receptor alpha )
    |
    ELU001