Singapore, 2 June 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 the publication of positive phase 1b results of its lead drug, varlitinib, in combination with doublet chemotherapy, to treat patients with metastatic solid tumours. An abstract publication of the data was published at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place on 2-6 June in Chicago, Illinois.
Varlitinib is a potent, reversible, small molecule pan-HER inhibitor. Data from the phase 1b study indicated that varlitinib in combination with cisplatin and 5-fluorouracil (cis/5FU) or cisplatin and capecitabine (cis/cap) is safe, well tolerated and has demonstrated strong efficacy signals in cholangiocarcinoma.
The phase 1b dose escalation study was conducted to determine the safety and early efficacy signals of varlitinib in combination with cis/5FU or cis/cap, with a view to identifying the recommended dose for future studies. Doses of varlitinib were escalated with corresponding chemotherapy for six cycles after which patients remained on varlitinib monotherapy.
To date, 27 patients have been enrolled in the study which is estimated to complete at the end of 2017. Three of 15 evaluable patients (20%) showed partial response, 10 had stable disease (67%), and two had progressive disease (13%). One cholangiocarcinoma patient demonstrated an 87% reduction in tumour size by Cycle 2 and a complete resolution in one lesion by Cycle 4. Another cholangiocarcinoma patient without measurable lesions in the liver or biliary tract achieved long-term disease control for a total of 15.2 months with good tolerability on varlitinib as monotherapy. Adverse events reported included nausea, vomiting and diarrhoea, and were clinically manageable.
Dr Mark McHale, Chief Operating Officer, ASLAN Pharmaceuticals said: “We are encouraged by the signals of efficacy, notably in the significant reduction in tumour size. We look forward with confidence as we continue studies of varlitinib, including late stage trials in indications, such as biliary tract cancer, where there is a pressing unmet medical need.” The abstract titled Initial signals of efficacy in cholangiocarcinoma from a phase 1b trial of varlitinib in combination with doublet chemotherapy (cisplatin + 5-fluororacil or capecitabine) is now available on the ASCO website.
Media contact
Chris Fang
ASLAN Pharmaceuticals
Tel: +886 2 2758 3333
E-mail: media@aslanpharma.com
Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 6340 7287
Email: ASLAN@spurwingcomms.com
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, enabling the Company to conduct and support regional clinical development programmes. The Company is developing 5 drugs addressing multiple indications including biliary tract cancer, gastric cancer and breast cancer. ASLAN has several compounds in late stage development: varlitinib (ASLAN001), a pan-HER inhibitor which has completed phase 2 studies in gastric and breast cancer, and is entering pivotal studies for biliary tract cancer; and ASLAN002 (partnered with BMS), a RON and cMET inhibitor in phase 2 development for gastric and breast cancer. www.aslanpharma.com
Cautionary statement
All materials and information set out herein are for reference only and whilst we make every effort to ensure accuracy and completeness, we cannot guarantee this. We make no recommendation as to the competence or suitability of persons or entities referenced herein (if any). Nothing herein constitutes an invitation or offer to invest in or deal in the securities of ASLAN. Anyone considering investment in ASLAN should refer to the information officially published the Taiwan Stock Exchange Market Observation System (MOPS). All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on such forward-looking statements, which are inherently unreliable, and you should not rely on them. Any such forward-looking statement will have been based on ASLAN’s expectations, assumptions, estimates and projections about future events on the date(s) made. Actual outcomes are subject to numerous risks and uncertainties, many of which relate to factors beyond ASLAN’s control, that could cause them to differ materially from those expressed in a forward-looking statement. ASLAN has no obligation to update or otherwise revise any forward-looking statements to reflect the occurrence of unanticipated events or for any other reason.
Varlitinib is a potent, reversible, small molecule pan-HER inhibitor. Data from the phase 1b study indicated that varlitinib in combination with cisplatin and 5-fluorouracil (cis/5FU) or cisplatin and capecitabine (cis/cap) is safe, well tolerated and has demonstrated strong efficacy signals in cholangiocarcinoma.
The phase 1b dose escalation study was conducted to determine the safety and early efficacy signals of varlitinib in combination with cis/5FU or cis/cap, with a view to identifying the recommended dose for future studies. Doses of varlitinib were escalated with corresponding chemotherapy for six cycles after which patients remained on varlitinib monotherapy.
To date, 27 patients have been enrolled in the study which is estimated to complete at the end of 2017. Three of 15 evaluable patients (20%) showed partial response, 10 had stable disease (67%), and two had progressive disease (13%). One cholangiocarcinoma patient demonstrated an 87% reduction in tumour size by Cycle 2 and a complete resolution in one lesion by Cycle 4. Another cholangiocarcinoma patient without measurable lesions in the liver or biliary tract achieved long-term disease control for a total of 15.2 months with good tolerability on varlitinib as monotherapy. Adverse events reported included nausea, vomiting and diarrhoea, and were clinically manageable.
Dr Mark McHale, Chief Operating Officer, ASLAN Pharmaceuticals said: “We are encouraged by the signals of efficacy, notably in the significant reduction in tumour size. We look forward with confidence as we continue studies of varlitinib, including late stage trials in indications, such as biliary tract cancer, where there is a pressing unmet medical need.” The abstract titled Initial signals of efficacy in cholangiocarcinoma from a phase 1b trial of varlitinib in combination with doublet chemotherapy (cisplatin + 5-fluororacil or capecitabine) is now available on the ASCO website.
Media contact
Chris Fang
ASLAN Pharmaceuticals
Tel: +886 2 2758 3333
E-mail: media@aslanpharma.com
Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 6340 7287
Email: ASLAN@spurwingcomms.com
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, enabling the Company to conduct and support regional clinical development programmes. The Company is developing 5 drugs addressing multiple indications including biliary tract cancer, gastric cancer and breast cancer. ASLAN has several compounds in late stage development: varlitinib (ASLAN001), a pan-HER inhibitor which has completed phase 2 studies in gastric and breast cancer, and is entering pivotal studies for biliary tract cancer; and ASLAN002 (partnered with BMS), a RON and cMET inhibitor in phase 2 development for gastric and breast cancer. www.aslanpharma.com
Cautionary statement
All materials and information set out herein are for reference only and whilst we make every effort to ensure accuracy and completeness, we cannot guarantee this. We make no recommendation as to the competence or suitability of persons or entities referenced herein (if any). Nothing herein constitutes an invitation or offer to invest in or deal in the securities of ASLAN. Anyone considering investment in ASLAN should refer to the information officially published the Taiwan Stock Exchange Market Observation System (MOPS). All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on such forward-looking statements, which are inherently unreliable, and you should not rely on them. Any such forward-looking statement will have been based on ASLAN’s expectations, assumptions, estimates and projections about future events on the date(s) made. Actual outcomes are subject to numerous risks and uncertainties, many of which relate to factors beyond ASLAN’s control, that could cause them to differ materially from those expressed in a forward-looking statement. ASLAN has no obligation to update or otherwise revise any forward-looking statements to reflect the occurrence of unanticipated events or for any other reason.
