SLC-391 / SignalChem Lifesci, Sihuan Pharmaceutical - LARVOL DELTA

A Study of XZB-0004 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=128 | Recruiting | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

KEYNOTE-C62: Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers (clinicaltrials.gov) - P1/2 | N=92 | Recruiting | Sponsor: SignalChem Lifesciences Corporation | Trial completion date: Dec 2027 ➔ Sep 2028 | Trial primary completion date: Dec 2025 ➔ Sep 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • KRAS • PD-L1 • ROS1

KEYNOTE-C62: Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers (clinicaltrials.gov) - P1/2 | N=98 | Recruiting | Sponsor: SignalChem Lifesciences Corporation | Phase classification: P1b/2 ➔ P1/2

Phase classification • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • KRAS • PD-L1 • ROS1

Safety Study of SLC-391 in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: SignalChem Lifesciences Corporation | Recruiting ➔ Completed | N=50 ➔ 35 | Trial completion date: Sep 2023 ➔ Jun 2023 | Trial primary completion date: Sep 2023 ➔ Jun 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

KEYNOTE-C62: Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers (clinicaltrials.gov) - P1b/2 | N=102 | Recruiting | Sponsor: SignalChem Lifesciences Corporation | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • KRAS • PD-L1 • ROS1

Safety Study of SLC-391 in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: SignalChem Lifesciences Corporation | Trial completion date: Nov 2022 ➔ Sep 2023 | Trial primary completion date: Nov 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of XZB-0004 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=128 | Not yet recruiting | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

To Evaluate the Phase I Clinical Study of XZB-0004 in Patients With AML and MDS (clinicaltrials.gov) - P1 | N=82 | Not yet recruiting | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of SLC-391 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: SignalChem Lifesciences Corporation | Recruiting ➔ Completed

Trial completion

Safety Study of SLC-391 in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: SignalChem Lifesciences Corporation | Trial completion date: Dec 2021 ➔ Nov 2022 | Trial primary completion date: Dec 2021 ➔ Nov 2022

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of SLC-391 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: SignalChem Lifesciences Corporation

New P1 trial

Xuanzhu and SignalChem Lifesciences Announce Collaboration and Licensing Agreement for SLC-391 in Greater China (EIN Presswire) - "Sihuan Pharmaceutical Holdings Group Ltd., together with its subsidiaries and SignalChem Lifesciences Corporation today announced that Sihuan Pharmaceutical Holdings Group Ltd subsidiary company Xuanzhu Biopharmaceutical Co., Ltd. ('Xuanzhu') and SignalChem Lifesciences Corporation ('SignalChem') have entered into an exclusive collaboration and licensing agreement for the clinical development and commercialization of SLC-391, a potent and selective AXL targeting inhibitor, in the Greater China region. Under the terms of the agreement, Xuanzhu will pay to SignalChem an upfront fee of thirteen million US dollars (US$13,000,000). Additional development milestones and royalties have also been committed. The exclusive rights for SLC-391 for the field of oncology is for the Greater China region (Mainland China, Hong Kong, Macau and Taiwan)."

Licensing / partnership • Oncology

Safety Study of SLC-391 in Subjects With Solid Tumors (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: SignalChem Lifesciences Corporation; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

SignalChem Enters a Clinical Trial Collaboration with Merck to Evaluate the Effect of SLC-391 in Combination with KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer (PipelineReview) - "SignalChem Lifesciences...announces a collaboration with Merck, known as MSD outside of the United States and Canada, through a subsidiary, to evaluate the combination of SLC-391, a selective AXL inhibitor developed by SignalChem, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced non-small cell lung cancer (NSCLC)...The two companies plan to conduct the SKYLITE trial, a phase 2 study for patients with NSCLC."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology

AXL inhibitor promotes anti-tumor immunity through modulation of macrophage polarization (AACR 2018) - "This observation is supported by inhibition of tumor growth and the increased ratio of M1/M2-polarized TAMs from mice treated with SLC-391 in a CT-26 murine colon carcinoma syngeneic model, considering CT26 cells are not sensitive to SLC-391 in cell-based proliferation assay. In summary, in addition to direct inhibition of tumor cells, SLC-391 also appears to promote anti-tumor immunity through modulation of M2 to M1 transition."

IO Biomarker • Colorectal Cancer • Non Small Cell Lung Cancer

[VIRTUAL] Targeting AXL Kinase Sensitizes Acute Myeloid Leukemia Stem and Progenitor Cells to Venetoclax Treatment (ASH 2020) - "To test whether targeting of the AXL/GAS6 pathway is a feasible treatment strategy for AML, in particular to eradicate LSCs, we developed SLC-391, a novel, potent and selective AXL inhibitor. Importantly, the combination of AXL inhibition plus venetoclax treatment was not toxic to normal BM cells from healthy donors. Hence, our findings identify a promising, improved and specific treatment strategy for AML, particularly patients with high AXL/GAS6 expression."

IO Biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation • AXL • GAS6 • MLL

Safety Study of SLC-391 in Subjects With Solid Tumors (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: SignalChem Lifesciences Corporation; Trial completion date: Aug 2020 ➔ Jun 2021; Trial primary completion date: Aug 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety Study of SLC-391 in Subjects With Solid Tumors (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: SignalChem Lifesciences Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Safety Study of SLC-391 in Subjects With Solid Tumors (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: SignalChem Lifesciences Corporation; Trial completion date: May 2020 ➔ Aug 2020; Trial primary completion date: May 2020 ➔ Aug 2020

Clinical • Trial completion date • Trial primary completion date

Safety Study of SLC-391 in Subjects With Solid Tumors (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: SignalChem Lifesciences Corporation

Clinical • New P1 trial