ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, and Hyundai Pharm Co. Ltd. (Hyundai), a leading Korean pharmaceutical company, have entered a collaboration and licence agreement to develop and commercialise ASLAN001 (varlitinib) for the treatment of cholangiocarcinoma (CCA)in South Korea.
ASLAN001 is a potentially best-in-class small molecule pan-HER inhibitor targeted for cholangiocarcinoma, an aggressive form of bile duct cancer with no approved therapy and a very poor prognosis, and is also being studied in gastric and breast cancer. Worldwide, South Korea has one of the highest prevalence rates of cholangiocarcinoma and gastric cancer, with 4,000 and 30,000 new patients diagnosed annually respectively
Under the terms of agreement, ASLAN and Hyundai will collaborate closely to accelerate the development of ASLAN001 in South Korea and will conduct clinical trials to study the efficacy of the drug in CCA. Together, both parties intend to submit an Investigational New Drug Application to the Korean Ministry of Food and Drug Safety to initiate clinical trials in Korea for CCA before the end of 2015. Hyundai will pay to ASLAN upfront and development milestones and royalties on sales upon successful commercialisation of ASLAN001. Hyundai also retains the first rights of negotiation to develop and commercialise ASLAN001 for gastric and breast cancer in South Korea. ASLAN will retain co-marketing rights to ASLAN001 in South Korea.
ASLAN will continue the development of ASLAN001 in a Phase 2A/B study that commenced in December 2014 in second-line metastatic breast cancer across Asia. ASLAN001 was awarded Orphan Drug Designation by the US FDA in CCA in August 2015.
Firth said, "ASLAN001 is currently undergoing phase 2 trials in cholangiocarcinoma, gastric cancer, and breast cancer, and was recently awarded Orphan Drug Designation in cholangiocarcinoma by the US Food and Drug Association. Given the lack of effective treatments for cholangiocarcinoma, if we can reproduce some of the data we’ve generated in our earlier studies in the current phase 2 study, we may be able to apply for accelerated approval with phase 2 data alone.
Young Hak Kim, Hyundai Pharm Group Chief Executive Officer, added, “We are excited to add ASLAN001 to our growing portfolio of innovative therapeutic agents. This enhances our oncology pipeline and aligns with our long-term research and development strategy.
“ASLAN001 has demonstrated promising results in studies in cholangiocarcinoma, gastric and breast cancer, and we look forward to working together with ASLAN to deliver treatments that will improve the lives of patients in South Korea," he added.