ORIN1001 / Fosun Pharma - LARVOL DELTA

ORIN1001 in Patients with Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=58 | Completed | Sponsor: Orinove, Inc. | Active, not recruiting ➔ Completed | N=150 ➔ 58

Enrollment change • Trial completion • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Evaluation of Oral ORIN1001 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P1 | N=24 | Suspended | Sponsor: Orinove, Inc. | Active, not recruiting ➔ Suspended

Trial suspension • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • ELANE • IL6

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=150 | Completed | Sponsor: Orinove, Inc. | Active, not recruiting ➔ Completed | N=350 ➔ 150

Enrollment change • Monotherapy • Trial completion • Esophageal Squamous Cell Carcinoma • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • ERN1 • HER-2 • PGR

Targeting IRE1α alleviates the immunosuppressive tumor microenvironment in prostate cancer (AACR 2024) - "Furthermore, IRE1α inhibition by the small molecule MKC8866 (ORIN1001) that is in clinical trials significantly enhanced anti-PD-1 checkpoint inhibitor therapy in mice. Our findings indicate that IRE1α not only promotes cancer cell growth and survival, but it also strongly inhibits anti-tumor immunity in the PCa TME."

Biomarker • IO biomarker • Tumor microenvironment • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Population pharmacokinetic model for oral ORIN1001 in Chinese patients with advanced solid tumors. (PubMed, Front Pharmacol) - P1/2 | "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."

Journal • Metastases • PK/PD data • Oncology • Solid Tumor • ERN1 • XBP1

ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Orinove, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Jan 2023 ➔ Jan 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

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 | Sponsor: Orinove, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • ERN1 • HER-2 • PGR

Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: 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 • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • ELANE • IL6

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 | Sponsor: Orinove, Inc. | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • ERN1 • HER-2 • PGR • XBP1

ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Orinove, Inc. | Trial completion date: Mar 2023 ➔ Dec 2023

Trial completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P1b | N=24 | Active, not recruiting | Sponsor: Orinove, Inc. | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • ELANE

Early efficacy evaluation of ORIN1001, a first in class IRE1 alpha inhibitor, in advanced solid tumors. (ASCO 2023) - P1/2 | "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 • Breast Cancer • Colon Cancer • Colorectal Cancer • Fatigue • Febrile Neutropenia • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Lung Cancer • Mesothelioma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer • ER • ERN1 • HER-2 • PGR • XBP1

ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Orinove, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Oct 2022 ➔ Feb 2023

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

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 | Sponsor: Orinove, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jan 2023 ➔ Jun 2023

Combination therapy • Enrollment closed • Metastases • Monotherapy • Trial primary completion date • Esophageal Squamous Cell Carcinoma • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • ERN1 • HER-2 • PGR • XBP1

Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P1b | N=24 | Active, not recruiting | Sponsor: Orinove, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2023 ➔ Jun 2023 | Trial primary completion date: Dec 2022 ➔ Jun 2023

Enrollment closed • Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • ELANE

Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P1b | N=24 | Recruiting | Sponsor: Orinove, Inc. | Trial completion date: Aug 2022 ➔ Mar 2023 | Trial primary completion date: Jul 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • ELANE

Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P1b | N=24 | Recruiting | Sponsor: Orinove, Inc. | Trial completion date: Mar 2022 ➔ Aug 2022 | Trial primary completion date: Jan 2022 ➔ Jul 2022

Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • ELANE

ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Orinove, Inc. | Trial completion date: Jun 2022 ➔ Dec 2022 | Trial primary completion date: Jun 2022 ➔ Oct 2022

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

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 | Sponsor: Orinove, Inc. | Trial completion date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Mar 2022 ➔ Jan 2023

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Cervical Cancer • Esophageal Squamous Cell Carcinoma • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • ERN1 • HER-2 • PGR • XBP1

Fosun Pharma (02196): Fosun Hongchuang’s new drug ORIN1001 tablet for the treatment of idiopathic pulmonary fibrosis (IPF) was approved by the State Food and Drug Administration for clinical trials [Google translation] (Zhitong Finance) - "Fosun Pharma...announced that recently, Fosun Hongchuang (Suzhou) Pharmaceutical Technology Co., Ltd. (hereinafter referred to as 'Fosun Hongchuang'), a subsidiary of the company, received the approval from the State Drug Administration.... Fosun Hongchuang intends to conduct Phase I clinical trials of the new drug in China (excluding Hong Kong, Macau and Taiwan, the same below) when conditions are met."

New P1 trial • Idiopathic Pulmonary Fibrosis

ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov) - P1/2; N=150; Recruiting; Sponsor: Orinove, Inc.; Trial completion date: Mar 2022 ➔ Jun 2022; Trial primary completion date: Dec 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

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; Sponsor: Orinove, Inc.

Clinical • Combination therapy • Monotherapy • New P1/2 trial • Esophageal Squamous Cell Carcinoma • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • ERN1 • HER-2 • MRI • PGR • XBP1

[VIRTUAL] A phase 1/2 trial of ORIN1001, a first-in-class IRE1 inhibitor, in patients with advanced solid tumors. (ASCO 2021) - P1/2 | "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 • Breast Cancer • CNS Disorders • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • Thrombocytopenia • ERN1 • XBP1

ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov) - P1/2; N=150; Recruiting; Sponsor: 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 • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P1b; N=24; Recruiting; Sponsor: Orinove, Inc.; Trial completion date: Dec 2021 ➔ Mar 2022; Trial primary completion date: Sep 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • ELANE