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    DRUG:

    taladegib (ENV 101)

    i
    Other names: ENV 101, LY-2940680, LY2940680, LY 2940680, ENV-IPF-101, ENV-ONC-101, ENV-101
    Associations

    News

    Trials
    Company:
    Eli Lilly, Endeavor BioMed
    Drug class:
    Hedgehog cell-signalling pathway inhibitor, SMO protein inhibitor
    Related drugs:
    Associations

    News

    Trials
    4ms
    A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=94, Terminated, Eli Lilly and Company | Phase classification: P1b --> P1 | Completed --> Terminated; The study was terminated due to business considerations
    Phase classification • Trial termination
    |
    cisplatin • carboplatin • gemcitabine • Verzenio (abemaciclib) • samotolisib (LY3023414) • crenigacestat (LY3039478) • taladegib (ENV 101)
    6ms
    A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) (clinicaltrials.gov)
    P2, N=200, Recruiting, Endeavor Biomedicines, Inc. | Trial completion date: Jun 2026 --> Oct 2026 | Trial primary completion date: Jun 2026 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    taladegib (ENV 101)
    1year
    A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) (clinicaltrials.gov)
    P2, N=200, Recruiting, Endeavor Biomedicines, Inc. | Not yet recruiting --> Recruiting | N=320 --> 200
    Enrollment open • Enrollment change
    |
    taladegib (ENV 101)
    over1year
    A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) (clinicaltrials.gov)
    P2, N=320, Not yet recruiting, Endeavor Biomedicines, Inc.
    New P2 trial
    |
    taladegib (ENV 101)
    almost2years
    A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=41, Completed, Endeavor Biomedicines, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    taladegib (ENV 101)
    almost2years
    A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations (clinicaltrials.gov)
    P2, N=44, Active, not recruiting, Endeavor Biomedicines, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    PTCH1 (Patched 1)
    |
    PTCH1 mutation
    |
    taladegib (ENV 101)
    almost2years
    A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Endeavor Biomedicines, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    taladegib (ENV 101)
    over2years
    Metastatic Basal Cell Carcinoma: Treatment with a potentially best in class Hedgehog Inhibitor, Taladegib (EADV 2023)
    Patient was further treated by vismodegib for 12 months followed by Cemiplimab. For the first time we report here that mBCC patients who were refractory to current standard of care treatments responded to taladegib with a duration of response of around one year with fewer and manageable adverse effects.
    PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PTCH1 (Patched 1)
    |
    PTCH1 mutation
    |
    Libtayo (cemiplimab-rwlc) • Erivedge (vismodegib) • taladegib (ENV 101)
    over3years
    A phase II study evaluating the safety and efficacy of ENV-101 (taladegib) in patients with advanced solid tumors harboring PTCH1 loss of function mutations (ESMO 2022)
    Stage 1 (phase IIa) of this protocol will enroll a total of 44 patients randomized between two dose levels. In the presence of acceptable efficacy, stage 2 (phase IIb) of this protocol will expand enrollment using a single dose level.
    Clinical • P2 data
    |
    PTCH1 (Patched 1) • SMO (Smoothened Frizzled Class Receptor)
    |
    PTCH1 mutation • SMO mutation
    |
    taladegib (ENV 101)
    over3years
    A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations (clinicaltrials.gov)
    P2, N=44, Recruiting, Endeavor Biomedicines, Inc. | Not yet recruiting --> Recruiting | Initiation date: Jan 2022 --> May 2022
    Enrollment open • Trial initiation date
    |
    PTCH1 (Patched 1) • GLI1 (GLI Family Zinc Finger 1)
    |
    PTCH1 mutation
    |
    taladegib (ENV 101)
    almost4years
    A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Endeavor Biomedicines, Inc.
    New P2 trial
    |
    PTCH1 (Patched 1) • GLI1 (GLI Family Zinc Finger 1)
    |
    PTCH1 mutation
    |
    taladegib (ENV 101)
    4years
    Responses to LY2940680 in ovarian cancer cell lines demonstrate Hedgehog and WNT pathways crosstalk as potential biomarkers in clinical trials. (NCRI 2021)
    The value of these WNT pathway genes as predictive biomarkers of patient response to Hh inhibitors warrants further investigation. Impact statement Investigating crosstalk between Hh and WNT pathways could potentially lead to new therapies.
    Preclinical
    |
    GLI1 (GLI Family Zinc Finger 1) • MMP7 (Matrix metallopeptidase 7)
    |
    GLI1 expression
    |
    taladegib (ENV 101)