ASLAN Announces Initiation Of First Clinical Study In Hepatocellular Carcinoma For Varlitinib

Published: Sep 07, 2017

Singapore, 7 September 2017 - ASLAN Pharmaceuticals (ASLAN, 6497.TT), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, today announced that its partners at the National University Cancer Institute, Singapore (NCIS), a member of the National University Health System, have initiated the first clinical study of varlitinib in patients with advanced or metastatic hepatocellular carcinoma (HCC).

The phase 1b open label study will initially enrol patients to establish the maximum tolerated dose of varlitinib in patients with advanced or metastatic HCC for subsequent enrolment into an expansion stage of the study. An expansion cohort will investigate varlitinib in HCC patients with HER3 expression who have progressed from first line treatment with sorafenib. Additionally, the study will identify biomarkers predictive of response to varlitinib.

The study will assess the safety and tolerability of varlitinib and measure duration of response, progression free survival, disease control rate and overall survival. ASLAN will provide varlitinib and partial funding for the study.

Varlitinib is a potent, reversible, small molecule pan-HER inhibitor, and is currently being developed as an experimental therapy across multiple indications including biliary tract cancer, gastric cancer, metastatic breast cancer and metastatic colorectal cancer.

Hepatocellular carcinoma is the predominant primary liver cancer in many countries in Asia Pacific. It is the third most common cause of cancer-related deaths in the region[2].

Dr Mark McHale, Chief Operating Officer, ASLAN Pharmaceuticals said: “This is the first study to explore the potential of varlitinib as a treatment for liver cancer. The investigator-initiated trial by Dr Ho Jinghsan’s team will provide us with a greater understanding of this tumour type and the potential of varlitinib as a treatment in a new and important indication. Our clinical studies to date have established the effectiveness of varlitinib in a number of cancers, we look forward to reviewing the results of this study as we consider indications to broaden our disease portfolio for varlitinib further.”

Dr Ho Jingshan, Associate Consultant, Department of Haematology-Oncology, NCIS said: "The treatment landscape for advanced HCC is evolving, and there has been increasing research interest in the area of immunotherapy and targeted drugs for the treatment of liver cancer. Some of the genetic abnormalities in cancer cells may be targeted by these new drugs that are under development. Clinical trials give patients a chance at these new liver cancer treatments in a closely monitored medical setting."

Media contacts
Chris Fang
ASLAN Pharmaceuticals
Tel: +886 2 2758 3333

Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 6340 7287

About varlitinib (ASLAN001) Varlitinib (ASLAN001) is a potent small molecule inhibitor of the HER-family of receptor tyrosine kinases (RTKs). The type I RTK family consists of four distinct but closely related receptors: epidermal growth factor receptor (EGFR, ErbB1, HER1), epidermal growth factor receptor 2 (HER2, ErbB2), epidermal growth factor receptor 3 (HER3, ErbB3), and epidermal growth factor receptor 4 (HER4, ErbB4). Varlitinib is a potent, reversible, small molecule inhibitor of EGFR, HER2 and HER4. In a large variety of cancers, the overexpression and/or constitutive activation of EGFR and HER2 are often observed and frequently correlate with poor clinical prognosis. Therefore, by inhibiting the activation of the HER receptors via varlitinib, effects such as shrinkage of the tumour and longer survival can be anticipated. Varlitinib is currently being studied in biliary tract, breast and gastric cancers. Varlitinib has been granted orphan drug status in the USA for cholangiocarcinoma and gastric cancer and was awarded orphan drug status for the treatment of advanced biliary tract cancer after first line systemic therapy by the Korean MFDS.

About ASLAN Pharmaceuticals

ASLAN Pharmaceuticals (6497.TT) is an oncology focused biotechnology company developing a portfolio of immunotherapies and targeted drugs, focusing on Asia prevalent tumour types. Led by a highly experienced management team with global pharmaceutical expertise, ASLAN is headquartered in Singapore with a platform that reaches across the region via its offices in Taiwan, China and Australia. The Company is developing 5 drugs addressing multiple indications including biliary tract cancer, gastric cancer and colorectal cancer, and has two global pivotal studies in biliary tract cancer and gastric cancer underway. ASLAN’s partners include Array BioPharma, Bristol-Myers Squibb, Almirall and CSL.

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