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SignalChem Initiates Phase 1 Clinical Trial for SLC-391 in Subjects with Solid Tumours

Nov 7, 2019
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VANCOUVER, BRITISH COLUMBIA-(November 7, 2019) - SignalChem Lifesciences Corp. ("SLC"), a clinical stage biotech company, has dosed its first patient in a Phase 1 clinical trial studying the safety and tolerability of SLC-391, a potent and selective AXL inhibitor, at Princess Margaret Cancer Centre in Toronto, Ontario. The study marks a significant clinical milestone for SLC. By taking a targeted therapy approach, the Company aims to develop SLC-391 for the treatment of various forms of cancer.

AXL is a putative driver of diverse cellular processes that are critical for the development, growth, and spread of tumours, including proliferation, invasiveness and migration, epithelial-mesenchymal transition (EMT), stemness, angiogenesis, and immune modulation. It has also been associated with both intrinsic and acquired resistance to chemotherapeutic drugs (e.g, paclitaxel and cisplatin) and molecularly targeted therapies (e.g, erlotinib and gefitinib). AXL has emerged as an increasingly attractive target for anticancer therapies in recent years. SLC-391 is a novel, potent and specific small molecule AXL inhibitor. It has demonstrated antiproliferative activity against different tumour cell lines in vitro and established efficacy in different animal models including non-small cell lung carcinoma (NSCLC), chronic myeloid leukemia (CML) and acute myeloid leukemia (AML) models. It can also work with other approved targeted therapies synergistically in different animal models to potentiate anti-tumour activity.

"Targeting receptor tyrosine kinase AXL represents a promising new approach for treating cancers, especially for cancer metastases, cancer stem cell survival, and acquired resistance to chemotherapies and other targeted therapeutics. SLC has developed its potent, selective and orally bioavailable Axl inhibitor SLC-391 to meet these medical needs. This novel therapy could provide a meaningful and beneficial alternative to cancer patients", commented by Mr. Jun Yan, the CEO and founder of SLC.

About the Phase 1 Trial

The Phase 1 trial is an open-label, dose-escalation, and dose-expansion study of the safety and pharmacokinetics of the AXL Inhibitor SLC-391 administered orally to subjects with solid tumours. The study is being conducted with sites located at The Ottawa Hospital Cancer Centre in Ottawa, Ontario, Princess Margaret Cancer Centre in Toronto, Ontario, and Juravinski Cancer Centre in Hamilton, Ontario. The primary objectives are to evaluate the safety of oral SLC-391 and to determine the maximum tolerated dose (MTD) of SLC-391. The secondary objectives are to characterize the pharmacokinetic (PK) profile of SLC-391, to determine the recommended phase 2 dose (RP2D) of SLC-391 and to preliminarily evaluate the efficacy of SLC-391. For more information about this clinical trial, please visit https://clinicaltrials.gov/ct2/show/NCT03990454.

About SLC-391

SLC-391 is a potent, selective and orally bioavailable small molecule Axl inhibitor. Currently, the phase I clinical trial to evaluate the safety and tolerability of SLC-391 in cancer patients with solid tumour is on-going in Canada.

About SLC

SignalChem Lifesciences Corporation (“SLC”), headquartered in British Columbia, Canada, is a clinical-stage company developing novel targeted therapies for oncology. Its unique business model has been built upon two important pillars: the Bioreagents and Research Services business and the Drug Discovery and Development business. A group of scientists with extraordinary expertise and experience in kinase biology and drug discovery are working together cohesively to provide the best products and services to its customers around the world and to maximize the efficiency of its drug discovery efforts. For more information, please visit 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

SignalChem Adopts eTMF Connect to Enhance Clinical Programs & Better Serve Customers

Nov 5, 2019

Fast-Growing Canadian Life Science Company adopts eTMF Connect to drive greater efficiency and visibility across clinical studies.

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MONTREAL and RICHMOND, CA - Nov 5, 2019 - Montrium, a global leader in cloud-based software solutions for the life sciences, today announced that SignalChem has successfully implemented their eTMF Connect application to improve clinical operations in drug development for their oncology-related programs. SignalChem now benefits from a robust and powerful electronic Trial Master File solution with eTMF Connect, streamlining the management of clinical trial content between study teams, providing them with a centralized interface for effective collaboration.

Performing drug discovery and development to treat different types of cancers, SignalChem has seen significant growth in targeted therapies in recent years.SignalChem’slatest clinical program, the protein kinase AXL Inhibitor SLC-391 for cancer therapy, is set to act as a critical inhibitor for cancer cell growth and metastasis. AXL is believed to play key roles in cancer cell survival, angiogenesis, metastasis and therapeutic resistance, as well as anti-tumour immunity suppression.

SignalChem’s transition to a modern eTMF system allows for better oversight with a more dedicated collaborative environment for partners to connect through one platform resulting in the delivery of safer treatments to patients faster. “eTMF Connect allows for easy, direct access to critical TMF content and data. We can ensure that our clinical studies and their respective TMFs are managed with greater quality, visibility and efficiency to scale research efforts and continue growth,” said Dr. Zaihui Zhang, CSO and VP of R&D

Montrium was able to both deliver and support the rapid implementation of the eTMF Connect software, allowing the SignalChem teams to realize the benefits of an eTMF system far faster than initially expected.

“As a clinical-stage company with an ambitious pipeline, we need a leading technology platform to streamline our clinical operations,” said Dr. Zhang. “Montrium’s eTMF Connect application helps our study teams work efficiently remotely and gives our program leaders better visibility into trial master file quality, timeliness and completeness. From the first engagement with Montrium, it was clear they wanted to nurture a lasting partnership, and their attention to detail was obvious from the start.”

“We are thrilled to be working with SignalChem, a fellow Canadian company, and to help them empower their continued success in oncology research and development. This partnership attests to the positive impact cloud-based platforms have in the life sciences industry,” said Oliver Pearce, Director of Commercialization at Montrium.

Additional Information

•  For more information, please visit: www.montrium.com and www.signalchemlifesciences.com
•  To learn more about how eTMF Connect can improve your clinical trial operations, please visit www.montrium.com/etmf-connect
•  Connect with Montrium and SignalChem on LinkedIn

About Montrium

Founded in 2005, Montrium is one of the leading providers of cloud-based collaborative content management software to the life sciences industry. With experience in serving over 200 life science customers in 20+ countries, Montrium is committed to delivering an unparalleled customer experience to emerging growth organizations as a true technology partner. Montrium is headquartered in Montreal, Canada, with a European office in Brussels, Belgium.

About SignalChem

SignalChem Lifesciences Corporation (“SLC”), headquartered in British Columbia, Canada, is a clinical-stage company developing novel targeted therapies for oncology. Its unique business model has been built upon two important pillars: the Bioreagents and Research Services business and the Drug Discovery and Development business. A group of scientists with extraordinary expertise and experience in kinase biology and drug discovery are working together cohesively to provide the best products and services to its customers around the world and to maximize the efficiency of its drug discovery efforts.

Contact:
Madison Ramsay
Marketing Operations Lead, Montrium
+1 514 223 9153 ext. 218

Zaihui Zhang, PhD
CSO, VP R & D
Signalchem Lifesciences Corp.
+ 604 232 4600 ext. 114

SignalChem Lifesciences Corp. to Present Data on the Role of its AXL Inhibitor SLC-391 in Promoting Anti-Tumor Activity

April 9, 2018

•  AXL expression is up-regulated by transformed cells and the tumor microenvironment;
•  Up-regulation of AXL elicits an anti-inflammatory effect;
•  SLC-391 mediates a pro-inflammatory response by promoting a M2 to M1 transition; and
•  SLC-391 inhibits M2-induced epithelial mesenchymal transition (EMT).

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VANCOUVER, BRITISH COLUMBIA – April 9, 2018 – SignalChem Lifesciences Corporation (“SLC”) announced that it will present a poster detailing the preclinical data for its AXL inhibitor, SLC-391 at the AACR Annual Meeting, being held from April 14-18, 2018 in Chicago, IL.

Details of the poster to be presented are as follows:
Title: AXL inhibitor promotes anti-tumor immunity through modulation of macrophage polarization
Section: PO.ETO6.11 – Novel and Canonical Targets
Poster Session: Section 35
Date and Time: Tuesday, April 17; 8:00 AM – 12:00 PM
Presenter: Shenshen Lai, PhD. SignalChem Lifesciences Corporation

About SLC-391

SLC-391 is a selective small molecule inhibitor of AXL and other TAM family kinases (Tyro3 and Mer). Currently, IND-enabling GLP-toxicological studies are underway and are expected to be completed in Q3 2018. With favorable results, SignalChem plans to initiate Phase I clinical trials in Q4 2018.

About SLC

SLC is a privately held and clinical stage biotechnology company specializing in enabling personalized medicine strategies to improve human health. The company offers bio-reagents (tools and services used for research purposes) to organizations worldwide and leverages the internally developed enzyme technology platform to discover inhibitors of the untapped targets with a view of advancing these therapeutic programs into early clinical development stages. SLC’s current therapeutic development programs are related to hypoxia (cancer), specifically CAIX which is involved in mediating metastasis and AXL tyrosine kinase is involved in perpetuating resistance to standard chemo- and radiation therapy. SLC has established a strategic corporate alliance with Welichem Biotech Inc. to support the clinical development of its first program SLC-0111, a CAIX inhibitor for the treatment of metastatic cancer. A Phase 1B study evaluating SLC-0111 with gemcitabine in pancreatic cancer is expected to commence in Q2 2018. GLP toxicological studies for SLC’s second program, Axl inhibitor SLC-391, are currently underway with results to be expected in Q3 2018. SLC is actively seeking opportunities for a co-development partnership for the AXL program.

Forward-Looking Statements and Information

This release contains forward-looking statements that are not based on historical fact. 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 by such forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements.

The Terry Fox Laboratory and SignalChem Lifesciences to Present Data on the AXL Inhibitor SLC-0211 (SLC-391) at the 59th ASH Annual Meeting & Exposition

Dec. 8, 2017

•  Activation of the GAS6/AXL pathway plays a major role in the resistance to targeted therapies and conventional cytotoxic drugs;
•  Cells with high GAS6/AXL expression were more sensitive to SLC-0211 (SLC-391) than those with low GAS6 and/or AXL levels;
•  SLC-0211 (SLC-391) reduced colony forming cell (CFC) ability of CD34+ AML cells, but the inhibitory effect of SLC-0211 (SLC-391) was strikingly enhanced in re-plating assays, resulting in a significant reduction in re-plating efficiency of more primitive AML cells (75-97% inhibition) at doses that are not toxic to healthy cells;
•  Treatment with SLC-0211 (SLC-391) greatly reduced phosphorylation of AXLY779, AKTS473 and ERKT202/Y204 in AML cells in a dose-dependent manner as compared to control cells;
•  Targeting AXL is a promising strategy for AML cases characterized by populations of CD34+ cells that harbor specific mutations, coupled with elevated AXL/GAS6 activity.

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VANCOUVER, BRITISH COLUMBIA – Dec. 8, 2017 – SignalChem Lifesciences Corporation (“SLC”) announced that it will present a poster detailing the preclinical data for its AXL inhibitor, SLC-0211 (SLC-391) at the 59th ASH Annual Meeting & Exposition, being held from December 9 – 12, 2017 in Atlanta, Georgia.

Details of the poster to be presented are as follows:
Title: Targeting the GAS6/AXL Pathway with a Newly Developed, Selective AXL Inhibitor SLC-0211 in Acute Myeloid Leukemia Mutant Cells
Abstract Number: 616
Poster Session: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10; 6:00 PM - 8:00 PM
Presenter: Xiaojia Niu. Terry Fox Laboratory, British Columbia Cancer Agency; Department of Medical Genetics, University of British Columbia, Vancouver, BC, Canada; National Engineering Laboratory for AIDS Vaccine, Key Laboratory for Molecular Enzymology and Engineering, the Ministry of Education, School of Life Sciences, Jilin University, Changchun, P. R. China

About SLC-0211 (SLC-391)

SLC-0211 (SLC-391) is a selective small molecule inhibitor of AXL and other TAM family kinases (Tyro3 and Mer). Currently, IND-enabling GLP-toxicological studies are underway and are expected to be completed in Q4 2017. With favorable results, SignalChem plans to initiate Phase I clinical trials in Q3 2018.

About SLC

SLC is a privately held and clinical stage biotechnology company specializing in enabling personalized medicine strategies to improve human health. The company offers bio-reagents (tools and services used for research purposes) to organizations worldwide and leverages the internally developed enzyme technology platform to discover inhibitors of the untapped targets with a view of advancing these therapeutic programs into early clinical development stages. SLC’s current therapeutic development programs are related to hypoxia (cancer), specifically CAIX which is involved in mediating metastasis and AXL tyrosine kinase is involved in perpetuating resistance to standard chemo- and radiation therapy. SLC has established a strategic corporate alliance with Welichem Biotech Inc. to support the clinical development of its first program SLC-0111, a CAIX inhibitor for the treatment of metastatic cancer. A Phase 1B study evaluating SLC-0111 with gemcitabine in pancreatic cancer is expected to commence in Q1 2018. GLP toxicological studies for SLC’s second program, Axl inhibitor SLC-391, are currently underway with results to be expected in Q4, 2017. SLC is actively seeking opportunities for a co-development partnership for the AXL program.

Forward-Looking Statements and Information

This release contains forward-looking statements that are not based on historical fact. 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 by such forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements.

SignalChem Lifesciences to Present Data on the AXL Inhibitor SLC-391 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer

Oct. 25, 2017

•  SLC-391 inhibits CT-26 tumor growth by 37% in a 15-day efficacy study whereas PD-1 antibody delayed tumor growth by 27%;
•  Increases in the number of NK cells and the ratio of M1/M2-polarized macrophages were evident in the SLC-391 treatment group when compared to vehicle;
•  In combination with anti-PD1, SLC-391 significantly prolongs survival, reinforcing the implication of AXL inhibition in immuno-oncology.

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VANCOUVER, BRITISH COLUMBIA – Oct. 25, 2017 – SignalChem Lifesciences Corporation (“SLC”) announced that it will present a poster detailing the preclinical data for its AXL inhibitor, SLC-391 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held from October 26 – 30, 2017 in Philadelphia, Pennsylvania.

Details of the poster to be presented are as follows:
Title: Activity of the TAM kinase-targeting compound, SLC-391, is mediated by the engagement of the immune system in CT-26 syngeneic mouse model
Abstract Number: 522
Poster Session: PO.B10 – New Molecular Targets
Date and Time: Sunday, October 29; 12:30 – 4:00 PM
Presenter: Anthony Marotta, PhD. SignalChem Lifesciences Corporation

About SLC-391

SLC-391 is a selective small molecule inhibitor of AXL and other TAM family kinases (Tyro3 and Mer). Currently, IND-enabling GLP-toxicological studies are underway and are expected to be completed in Q4 2017. With favorable results, SignalChem plans to initiate Phase I clinical trials in Q3 2018.

About SLC

SLC is a privately held and clinical stage biotechnology company specializing in enabling personalized medicine strategies to improve human health. The company offers bio-reagents (tools and services used for research purposes) to organizations worldwide and leverages the internally developed enzyme technology platform to discover inhibitors of the untapped targets with a view of advancing these therapeutic programs into early clinical development stages. SLC’s current therapeutic development programs are related to hypoxia (cancer), specifically CAIX which is involved in mediating metastasis and AXL tyrosine kinase is involved in perpetuating resistance to standard chemo- and radiation therapy. SLC has established a strategic corporate alliance with Welichem Biotech Inc. to support the clinical development of its first program SLC-0111, a CAIX inhibitor for the treatment of metastatic cancer. A Phase 1B study evaluating SLC-0111 with gemcitabine in pancreatic cancer is expected to commence in Q1 2018. GLP toxicological studies for SLC’s second program, Axl inhibitor SLC-391, are currently underway with results to be expected in Q4, 2017. SLC is actively seeking opportunities for a co-development partnership for the AXL program.

Forward-Looking Statements and Information

This release contains forward-looking statements that are not based on historical fact. 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 by such forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements.

SignalChem Initiates Phase 1 Clinical Trial for SLC-0111 in Solid Tumours

Dec 4, 2014

SignalChem Lifesciences Corp. ("SLC"), has dosed its first patient in a Phase 1a clinical trial studying the safety and tolerability of SLC-0111. The study marks a significant clinical milestone for SLC. Taking a personalized medicine approach, the Company is developing SLC-0111 for the targeted treatment of various forms of cancer.

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VANCOUVER, BRITISH COLUMBIA--(Marketwired - Dec 4, 2014) - SignalChem Lifesciences Corp. ("SLC"), has dosed its first patient in a Phase 1a clinical trial studying the safety and tolerability of SLC-0111. The study marks a significant clinical milestone for SLC. Taking a personalized medicine approach, the Company is developing SLC-0111 for the targeted treatment of various forms of cancer. SLC-0111 is a proprietary small molecule that selectively targets CAIX enzyme within the hypoxic regions of the tumour. Hypoxic areas of tumours host aggressive cancer cells that are resistant to conventional therapies and CAIX plays a critical role in their survival. No drug therapies currently exist for blocking CAIX enzyme activity in hypoxic areas of solid tumours. "There is currently a significant unmet need for a treatment that could decrease the survival of cancer cells in the hypoxic regions of a tumour, said Jasbinder Sanghera, PhD., CEO of SLC. "Targeting the CAIX enzyme represents a promising new approach for treating and preventing tumour growth, especially recurrence, and SLC is the first company that has demonstrated success in reaching these difficult areas of the tumour. This therapy could provide a meaningful benefit to cancer patients." The initiation of clinical development for SLC-0111 follows extensive research and preclinical studies where the compound demonstrated consistently positive effects for the treatment of various tumours. "Our studies have demonstrated that SLC-0111 may work well in effectively stopping and shrinking various tumours, prevent recurrence, metastases, and cancer stem cell survival, commented Dr. Shoukat Dedhar, one of the original developers of the program, distinguished scientist and the Professor of the Department of Integrative Oncology, BC Cancer Research Centre and University of British Columbia. "This program may prove to be a major step forward in treating both tumour growth and spread in a segment of the tumour, which if left untreated, has a devastating impact on patients." SLC is also developing a backup small molecule inhibitor of CAIX (SLC-021) and in collaboration with the National Research Council of Canada, a monoclonal antibody (SLC-0131) targeting CAIX. Both programs are in the preclinical development stage.

About the Phase 1 Trial

The Phase 1a trial is a dose escalation study and the Company will enroll up to 30 cancer patients with refractory solid tumours. The study is being conducted by Ozmosis Research Inc., Toronto, ON with sites located at The Princess Margaret in Toronto, Ontario, the Cross Cancer Institute in Edmonton, Alberta and the BC Cancer Agency in Vancouver, BC. The primary objective is to investigate the safety and tolerability of SLC-0111. The company plans to start Phase 1b studies later in 2015. These trials will involve selecting patients whose tumours express CAIX and treating only these patients with SLC-0111.

About CAIX

SLC has identified and validated the metalloenzyme Carbonic Anhydrase IX (CAIX), which is expressed selectively on the cell surface of hypoxic (oxygen depleted) tumour cells particularly cancer stem cells, and is one of the major factors contributing to cancer cell survival and metastasis. The role of CAIX is to catalyse the reversible hydration of carbon dioxide to bicarbonate and protons: H2O + CO2 to HCO3- + H+.

About SLC

SignalChem Lifesciences ("SLC") discovers and develops drug candidates using a personalized medicine approach. We identify patients with a specific kinase defect and then select a relevant targeted therapy against the defective kinase. SLC's development process selects the most relevant kinase targets for drug development and identifies the best compound from our kinase specific chemical library. This ensures best-in-class potency and superior selectivity; yielding highly effective drug candidates with greatly reduced side effects. Our approach has the potential to provide a much more effective therapy and allows SLC to apply the therapy to only those patients who are most likely to receive a meaningful clinical benefit. For more information please visit www.signalchemcorp.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.