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, breast and colorectal cancer. Varlitinib is currently being studied in a global pivotal trial (TreeTopp) for biliary tract cancer, with topline data expected in 2H 2019. 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.
To date, we have completed four additional Phase 1b clinical trials and two Phase 2 clinical trials for this product candidate. Over 600 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 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 BioGenetics for the commercialisation of varlitinib and ASLAN003 in South Korea. BioGenetics, formerly Unidus Corporation, is a Korea-based company established in 1973 engaged in the manufacturing of medical products. As part of the company’s diversification strategy, BioGenetics established its biopharmaceutical division in April 2018 and appointed Mr Joohoon Ahn, as CEO of the newly established division. Mr Ahn was most recently Senior Managing Director at Kwangdong Pharmaceuticals, one of the top 3 domestic pharmaceutical companies in Korea, and has 28 years of experience in the Korean pharma industry in regulatory affairs, commercialisation, and business development. Biogenetics is co-developing WM-S1-001 for Erbitux®-resistant colon cancer with WellMarkerBio, a spin-off company from Asan Medical Center, one of the largest private hospitals in Korea.