SignalChem Lifesciences Corp. Obtains NOL from Health Canada for Clinical Trial of AXL Inhibitor SLC-391 in Combination with KEYTRUDA® (pembrolizumab) in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer
VANCOUVER, BC — SignalChem Lifesciences Corp. today announced that it has received a No Objection Letter (NOL) from Health Canada for its clinical trial “A Single-Arm, Open-Label, Phase 1b/2 Study of SLC-391, an AXL Inhibitor, in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)”.
AXL, a member of the TAM family protein tyrosine kinases (Tyro3, AXL and Mer). Over-expression of AXL leads to growth and spread of tumors, metastasis, EMT, tumor microenvironment deregulation, immune evasion, and resistance to multiple anticancer therapies including PD(L)-1. SLC-391 is a clinical stage small molecule AXL inhibitor with high potency, selectivity and desirable pharmaceutical properties. SLC-391 disrupts cell division, inhibiting tumor growth and causing cancer cells to die.
The trial will evaluate the safety and efficacy of SLC-391 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in subjects with advanced or metastatic non-small cell lung cancer (NSCLC). SignalChem and Merck (known as MSD outside the US and Canada) plan to conduct the study in multiple cancer centers in the US and Canada (SKYLITE trial).
“We are thrilled to receive the NOL from Health Canada for our clinical trial,” said Mr. Jun Yan, President and CEO of SignalChem. “This marks an important milestone in our mission to bring innovative treatments to patients with NSCLC. We are confident SLC-391 in combination with KEYTRUDA® may have the potential to make a significant impact on the lives of those affected by this devastating disease. We appreciate the opportunity to work with Health Canada and our collaborators in advancing our clinical trial. We look forward to reporting the results of this study and advancing our mission to improve the lives of patients with cancer.”
Health Canada’s rigorous review process ensures that new treatments are safe and effective for Canadians. The NOL for this trial is a testament to the quality of the research and development conducted by SignalChem and the scientific and medical communities involved in its development.
SignalChem is committed to developing innovative treatments for cancer and will continue to work with healthcare providers, patients, and regulatory agencies to bring new therapies to market.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Lung Cancer
Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than colon, breast and prostate cancers combined. NSCLC is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses. The overall 5-year survival rate for NSCLC is 24%, ranging from 61% for localized NSCLC to 6% for metastatic disease.
About SLC-391
SLC-391 is a potent, selective and orally bioavailable small molecule AXL inhibitor. Currently, phase I clinical trial is ongoing in Canada to evaluate the safety and tolerability of SLC-391 in cancer patients with solid tumour.
About SignalChem
SignalChem Lifesciences Corporation (“SLC”), headquartered in British Columbia, Canada, is a clinical-stage company developing novel targeted therapies for oncology. SLC has a strong small-molecule drug development pipeline (https://signalchemlifesciences.com/pipeline.php). Our novel targeted compounds are designed internally by a group of scientists with expertise and experience in kinase biology and drug discovery. SLC is seeking strategic partners to aid in bringing our clinical-stage drug pipeline to the market.
SignalChem (https://www.signalchem.com), a separate division from SignalChem Lifesciences, is a biotech company focused on the research, development and production of innovative and high-quality human recombinant cell signaling products. Throughout the years, SignalChem has capitalized on its core expertise in cellular signaling, molecular biology and protein biochemistry to generate more than 2,000 functional protein products.
SignalChem strives to support scientists in academia, pharma and biotech companies around the world by creating effective research tools to advance the basic research in life sciences and to facilitate the efforts in drug discovery and development.
For more information, please visit https://www.signalchemlifesciences.com.
Forward-Looking Statements and Information
This release contains forward-looking statements that are not based on historical facts. These forward-looking statements involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied. Readers are cautioned not to place undue reliance on such forward-looking statements.
Contact:
Zaihui Zhang, PhD
CSO, VP R & D
SignalChem Lifesciences Corp.
+ 604 232 4600 ext. 114