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    DRUG:

    ORIN1001

    i
    Other names: ORIN1001, ORIN 1001, ORIN-1001
    Company:
    Fosun Pharma
    Drug class:
    ERN1 inhibitor
    Related drugs:
    8ms
    Population pharmacokinetic model for oral ORIN1001 in Chinese patients with advanced solid tumors. (PubMed, Front Pharmacol)
    The necessity of dose adjustments based on these two covariates remains to be validated in a larger population. The first PopPK model of ORIN1001 was successfully constructed, which may provide some important references for future research.
    PK/PD data • Journal • Metastases
    |
    ERN1 (Endoplasmic Reticulum To Nucleus Signaling 1) • XBP1 (X-box-binding protein 1)
    |
    ORIN1001
    8ms
    ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=150, Active, not recruiting, Orinove, Inc. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • ORIN1001
    8ms
    ORIN1001-C1: Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care. (clinicaltrials.gov)
    P1/2, N=350, Active, not recruiting, Orinove, Inc. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ERN1 (Endoplasmic Reticulum To Nucleus Signaling 1)
    |
    HER-2 negative
    |
    ORIN1001
    8ms
    Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, Orinove, Inc. | Phase classification: P1b --> P1 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Phase classification • Trial completion date • Trial primary completion date
    |
    IL6 (Interleukin 6)
    |
    ORIN1001
    over1year
    ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=150, Active, not recruiting, Orinove, Inc. | Trial completion date: Mar 2023 --> Dec 2023
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • ORIN1001
    over1year
    ORIN1001-C1: Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care. (clinicaltrials.gov)
    P1/2, N=350, Active, not recruiting, Orinove, Inc. | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ERN1 (Endoplasmic Reticulum To Nucleus Signaling 1) • XBP1 (X-box-binding protein 1)
    |
    HER-2 negative
    |
    ORIN1001
    over1year
    Early efficacy evaluation of ORIN1001, a first in class IRE1 alpha inhibitor, in advanced solid tumors. (ASCO 2023)
    Phase 1 clinical evaluation of ORIN1001 has demonstrated tolerability and dose proportional PK. The proposed RP2D is estimated to be 500 mg and 300 mg ORIN1001 for single agent and in combination with Abraxane, respectively. Early efficacy data with ORIN1001 demonstrate clinical responses (SD and PR) in multiple pts with heavily-pretreated advanced solid tumors as a single agent or in combination with Abraxane in breast cancer patients.
    Clinical • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ERN1 (Endoplasmic Reticulum To Nucleus Signaling 1) • XBP1 (X-box-binding protein 1)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • ORIN1001
    almost2years
    ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=150, Active, not recruiting, Orinove, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • ORIN1001
    almost2years
    ORIN1001-C1: Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care. (clinicaltrials.gov)
    P1/2, N=350, Active, not recruiting, Orinove, Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2023 --> Jun 2023
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ERN1 (Endoplasmic Reticulum To Nucleus Signaling 1) • XBP1 (X-box-binding protein 1)
    |
    HER-2 negative
    |
    ORIN1001
    over2years
    ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Orinove, Inc. | Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Oct 2022
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • ORIN1001
    over2years
    ORIN1001-C1: Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care. (clinicaltrials.gov)
    P1/2, N=350, Recruiting, Orinove, Inc. | Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Mar 2022 --> Jan 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ERN1 (Endoplasmic Reticulum To Nucleus Signaling 1) • XBP1 (X-box-binding protein 1)
    |
    HER-2 negative
    |
    ORIN1001
    almost3years
    ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Orinove, Inc. | Trial completion date: Mar 2022 --> Jun 2022 | Trial primary completion date: Dec 2021 --> Jun 2022
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • ORIN1001
    almost3years
    ORIN1001-C1: Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care. (clinicaltrials.gov)
    P1/2, N=350, Recruiting, Orinove, Inc.
    Clinical • New P1/2 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ERN1 (Endoplasmic Reticulum To Nucleus Signaling 1) • XBP1 (X-box-binding protein 1)
    |
    HER-2 negative
    |
    ORIN1001
    over3years
    ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Orinove, Inc. | Trial completion date: Nov 2021 --> Mar 2022 | Trial primary completion date: Jun 2021 --> Dec 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • ORIN1001
    over3years
    [VIRTUAL] A phase 1/2 trial of ORIN1001, a first-in-class IRE1 inhibitor, in patients with advanced solid tumors. (ASCO 2021)
    To date, the phase 1 part of the first-in-human trial has demonstrated a reasonable safety and pharmacokinetic profile for ORIN1001 at 100mg and 200mg dose levels . While efficacy data have yet to mature, chronic dosing achieved in pts with heavily treated advanced solid tumors, suggests clinical potential for in the setting of advanced solid cancers . The phase 2 part of the trial testing ORIN1001 in combination with Abraxane is currently enrolling pts with advanced breast cancer.
    Clinical • P1/2 data
    |
    ERN1 (Endoplasmic Reticulum To Nucleus Signaling 1) • XBP1 (X-box-binding protein 1)
    |
    albumin-bound paclitaxel • ORIN1001
    4years
    ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Orinove, Inc. | Phase classification: P1 --> P1/2 | Trial primary completion date: May 2020 --> Jun 2021
    Clinical • Phase classification • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    albumin-bound paclitaxel • ORIN1001