Singapore, 15 September, 2015 – ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, today announced the simultaneous approval of its Clinical Trial Applications (CTA) in Singapore and Taiwan to conduct a phase 2 study to assess the efficacy of ASLAN001 (varlitinib) in second-line cholangiocarcinoma, an aggressive form of bile duct cancer with no approved therapy and a very poor prognosis.
Earlier studies have shown ASLAN001 to be efficacious as both monotherapy and in combination with chemotherapy in cholangiocarcinoma. This phase 2 study will further evaluate its efficacy in a larger group of patients. ASLAN001 received Orphan Drug Designation from the US FDA in August 2015.
“We are very pleased to see the fast response of the Singapore Health Services Authority and the Taiwan Food and Drug Administration, allowing us to run a study in this patient population where there is such significant unmet need,” said Dr Mark McHale, Chief Operating Officer of ASLAN Pharmaceuticals.
“This will be the first systematic test of the efficacy of our pan-HER inhibitor, ASLAN001, in cholangiocarcinoma, and builds on the recent collaborations we have established in Singapore with the National Cancer Centre of Singapore and in Taiwan with ACT Genomics to understand this disease better.”
Media contacts
Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 9107 5559
Email: ASLAN@spurwingcomms.com
About ASLAN001
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). ASLAN001 is a potent, reversible 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 ASLAN001, effects such as shrinkage of the tumor and longer survival can be anticipated. ASLAN001 is currently being studied in breast cancer and studies in gastric cancer and cholangiocarcinoma are underway.
About Cholangiocarcinoma
Cholangiocarcinoma is cancer of the biliary tract and is currently classified into two subtypes - intrahepatic or extrahepatic. Globally, cholangiocarcinoma is the second most common form of liver cancer. Cholangiocarcinoma is a very heterogeneous and poorly understood disease for which there are currently no approved targeted therapies. There is strong scientific rationale for HER cMET and RON inhibitors in cholangiocarcinoma, demonstrating aberrant pathway activity with disease progression. ASLAN is currently planning further clinical trials of ASLAN001 in cholangiocarcinoma, targeting the HER, cMET and RON pathways.
About ASLAN Pharmaceuticals
About ASLAN Pharmaceuticals ASLAN Pharmaceuticals 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 which reaches across the region via its offices in Taiwan and China, enabling the Company to conduct and support regional clinical development programmes. The Company’s proprietary pipeline of 4 development-stage candidates addresses multiple indications including gastric and breast cancers and inflammatory diseases. ASLAN’s most advanced compounds are in phase 2: ASLAN001, a pan-HER inhibitor with phase 2 data in gastric cancer, being developed in cholangiocarcinoma, breast cancer and gastric cancer; and ASLAN002, which targets RON, an immune checkpoint inhibitor, and cMET. www.aslanpharma.com
Help employers find you! Check out all the jobs and post your resume.
Earlier studies have shown ASLAN001 to be efficacious as both monotherapy and in combination with chemotherapy in cholangiocarcinoma. This phase 2 study will further evaluate its efficacy in a larger group of patients. ASLAN001 received Orphan Drug Designation from the US FDA in August 2015.
“We are very pleased to see the fast response of the Singapore Health Services Authority and the Taiwan Food and Drug Administration, allowing us to run a study in this patient population where there is such significant unmet need,” said Dr Mark McHale, Chief Operating Officer of ASLAN Pharmaceuticals.
“This will be the first systematic test of the efficacy of our pan-HER inhibitor, ASLAN001, in cholangiocarcinoma, and builds on the recent collaborations we have established in Singapore with the National Cancer Centre of Singapore and in Taiwan with ACT Genomics to understand this disease better.”
Media contacts
Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 9107 5559
Email: ASLAN@spurwingcomms.com
About ASLAN001
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). ASLAN001 is a potent, reversible 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 ASLAN001, effects such as shrinkage of the tumor and longer survival can be anticipated. ASLAN001 is currently being studied in breast cancer and studies in gastric cancer and cholangiocarcinoma are underway.
About Cholangiocarcinoma
Cholangiocarcinoma is cancer of the biliary tract and is currently classified into two subtypes - intrahepatic or extrahepatic. Globally, cholangiocarcinoma is the second most common form of liver cancer. Cholangiocarcinoma is a very heterogeneous and poorly understood disease for which there are currently no approved targeted therapies. There is strong scientific rationale for HER cMET and RON inhibitors in cholangiocarcinoma, demonstrating aberrant pathway activity with disease progression. ASLAN is currently planning further clinical trials of ASLAN001 in cholangiocarcinoma, targeting the HER, cMET and RON pathways.
About ASLAN Pharmaceuticals
About ASLAN Pharmaceuticals ASLAN Pharmaceuticals 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 which reaches across the region via its offices in Taiwan and China, enabling the Company to conduct and support regional clinical development programmes. The Company’s proprietary pipeline of 4 development-stage candidates addresses multiple indications including gastric and breast cancers and inflammatory diseases. ASLAN’s most advanced compounds are in phase 2: ASLAN001, a pan-HER inhibitor with phase 2 data in gastric cancer, being developed in cholangiocarcinoma, breast cancer and gastric cancer; and ASLAN002, which targets RON, an immune checkpoint inhibitor, and cMET. www.aslanpharma.com
Help employers find you! Check out all the jobs and post your resume.
