Varlitinib is a highly potent, oral, reversible, small molecule inhibitor of the human epidermal growth factor receptor, or HER, family of receptor tyrosine kinases, or RTKs. Approved drugs that selectively target HER1 (also known as EGFR) or HER2 have been effective in some patients. However, patients may relapse on or may not respond to these therapies because the growth of their cancers is driven by other HER family receptors. Varlitinib has demonstrated activity in a range of tumour types including biliary tract, gastric, breast and colorectal cancer. Varlitinib is currently being studied in a global pivotal trial (TreeTopp) for biliary tract cancer, and a Phase 2/3 trial for gastric cancer. We are also testing varlitinib in a single-arm pivotal clinical trial in biliary tract cancer in China. We have exclusive global rights to develop, manufacture and commercialise varlitnib for all human and animal therapeutic, diagnostic and prophylactic uses.
Varlitinib targets multiple members of the HER family of receptors and we believe it may be effective in a broader range of tumour types and effective in patients that have progressed on prior HER1-selective or HER2-selective therapies.
Our assessment of varlitinib and understanding of its mechanism of action led us to believe that it would be effective in gastric cancer and that we were well positioned to accelerate the development of varlitinib through our Asia development platform.
To date, we have completed four additional Phase 1b clinical trials and two Phase 2 clinical trials for this product candidate. Over 400 patients have been dosed with varlitinib as monotherapy or in combination with other agents. In these clinical trials, varlitinib was well-tolerated in Caucasian and Asian patients.
We have obtained orphan drug designation from the US FDA for varlitinib in gastric cancer and cholangiocarcinoma, which represents approximately 60% of biliary tract cancer cases.
We have also obtained orphan drug designation from the Ministry of Food and Drug Safety in South Korea for varlitinib in biliary tract cancer.
ASLAN has partnered with Array BioPharma Inc for the development of varlitinib (ASLAN001). Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialisation of targeted small-molecule drugs to treat patients afflicted with cancer and inflammatory diseases. Array’s proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs. To learn more about Array, please visit www.arraybiopharma.com.
ASLAN has partnered with HYUNDAI Pharmaceuticals to develop and commercialise varlitinib (ASLAN001) in South Korea. Founded in 1965, HYUNDAI Pharm Co Ltd, with its base in Seoul, Korea, is a pharmaceutical company specialised in modern medicine. HYUNDAI is a leading expert in various therapeutic categories, including CV and respiratory system, and the company is expanding into additional areas including women’s health, CNS, and oncology. HYUNDAI engages in manufacturing and sales of more than 200 products in prescription medications, OTC medications, FDA-approved hair loss treatments, and health functional beverages. Concurrently, HYUNDAI is investing in pharmaceutical product development, most recently in the in-house development of novel Type II diabetes molecules, as well as co-development agreements with foreign biotech companies and universities.
To learn more about HYUNDAI, please visit www.hyundaipharm.co.kr.