Delving into the Latest Updates on ORIN-1001 with Synapse

This Phase 1b trial is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of oral ORIN1001 at 25 mg, 50 mg or 100 mg administered daily for up to 28 days in adult subjects with idiopathic pulmonary fibrosis (IPF) alone or in conjunction with local Standard of Care for IPF (pirfenidone or nintedanib).
A maximum of 24 evaluable subjects will be required to complete the study. The study will consist of 3 dose cohorts each enrolling a maximum of 8 subjects randomized either to the active (5 subjects) group or placebo (3 subjects) group. Each subject will receive daily oral doses of ORIN1001 or placebo for 28 days.
The safety and pharmacokinetic profile will be evaluated in this study and will include cardiovascular and pulmonary endpoints.

Start Date09 Feb 2021

Sponsor / Collaborator

Fosun Orinove Pharmatech Inc

[+1]

CTR20200281 / TerminatedPhase 1

一项多中心、开放、I 期临床研究：评价 ORIN1001 在晚期恶性实体瘤患者中的单药和联合治疗的剂量探索及剂量扩展研究

[Translation] A multicenter, open-label, phase I clinical study: a dose-finding and dose-expansion study evaluating ORIN1001 as a monotherapy and in combination therapy in patients with advanced malignant solid tumors

1.观察单药和联合用药 ORIN1001 在晚期恶性实体瘤患者中的安全性和耐受性。 2.确定单药 ORIN1001和联合用药在晚期实体瘤中的 II 期临床研究推荐剂量。 3.观察单药 ORIN1001 和联合用药在各个不同实体瘤适应症中的抗肿瘤活性，安全性和耐受性。 4.评价ORIN1001单药和联合用药的药代动力学特征。 5.探索肿瘤生物标志物的变化情况，并初步评估和疗效之间的相关性。

[Translation]

1. Observe the safety and tolerability of ORIN1001 as a single agent and in combination in patients with advanced malignant solid tumors. 2. Determine the recommended dose for Phase II clinical studies of ORIN1001 as a single agent and in combination in advanced solid tumors. 3. Observe the anti-tumor activity, safety and tolerability of ORIN1001 as a single agent and in combination in various solid tumor indications. 4. Evaluate the pharmacokinetic characteristics of ORIN1001 as a single agent and in combination. 5. Explore the changes in tumor biomarkers and preliminarily evaluate the correlation with efficacy.

Start Date23 Nov 2020

Sponsor / Collaborator

Fosun Orinove Pharmatech Inc

NCT05154201 / Active, not recruitingPhase 1/2

A Multicenter, Open-label, Phase I Clinical Study: A Dose-finding and Dose Expansion Study to Evaluate ORIN1001 Monotherapy and Its Combination in Patients With Advanced Solid Malignant Tumors

Dose escalation of ORIN1001 in patients with advanced solid tumors.
Dose escalation of ORIN1001 in combination with standard of care in patients with esophageal carcinoma, metastatic breast cancer, hepatocellular carcinoma, metastatic prostate cancer, pancreatic cancer, ovarian cancer and non-small cell lung cancer.
Dose expansion of ORIN1001 as a single agent or in combination with standard of care in patients with advanced solid tumors.

Start Date01 Jul 2020

Sponsor / Collaborator

Fosun Orinove Pharmatech Inc

[+1]

100 Clinical Results associated with ORIN-1001

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100 Translational Medicine associated with ORIN-1001

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100 Patents (Medical) associated with ORIN-1001

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Literatures (Medical) associated with ORIN-1001

Frontiers in Pharmacology

Population pharmacokinetic model for oral ORIN1001 in Chinese patients with advanced solid tumors

Article

Author: Liu, Lu ; Greene, Stephanie ; Patterson, John ; Li, Xiaoqing ; Bo, Yunhai ; Zeng, Qingping ; Yang, Fen ; Diao, Lei

Background: ORIN1001, a first-in-class oral IRE1-α endoribonuclease inhibitor to block the activation of XBP1, is currently in clinical development for inhibiting tumor growth and enhancing the effect of chemical or targeted therapy. Early establishment of a population pharmacokinetic (PopPK) model could characterize the pharmacokinetics (PK) of ORIN1001 and evaluate the effects of individual-specific factors on PK, which will facilitate the future development of this investigational drug.Methods: Non-linear mixed effect model was constructed by Phoenix NLME software, utilizing the information from Chinese patients with advanced solid tumors in a phase I clinical trial (Register No. NCT05154201). Statistically significant PK covariates were screened out by a stepwise process. The final model, after validating by the goodness-of-fit plots, non-parametric bootstrap, visual predictive check and test of normalized prediction distribution errors, was further applied to simulate and evaluate the impact of covariates on ORIN1001 exposure at steady state up to 900 mg per day as a single agent.Results: A two-compartment model with first-order absorption (with lag-time)/elimination was selected as the best structural model. Total bilirubin (TBIL) and lean body weight (LBW) were considered as the statistically significant covariates on clearance (CL/F) of ORIN1001. They were also confirmed to exert clinically significant effects on ORIN1001 steady-state exposure after model simulation. The necessity of dose adjustments based on these two covariates remains to be validated in a larger population.Conclusion: The first PopPK model of ORIN1001 was successfully constructed, which may provide some important references for future research.

100 Deals associated with ORIN-1001

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 1	CN	Fosun Orinove Pharmatech Inc	30 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 1	CN	Fosun Orinove Pharmatech Inc	23 Nov 2020
Idiopathic Pulmonary Fibrosis	Phase 1	US	Shanghai Fosun Pharmaceutical (Group) Co., Ltd.	-
Idiopathic Pulmonary Fibrosis	Phase 1	CN	Shanghai Fosun Pharmaceutical (Group) Co., Ltd.	-
Solid tumor	Phase 1	CN	Shanghai Fosun Pharmaceutical (Group) Co., Ltd.	-