Varlitinib(ASLAN001)Pan-HER inhibitor
Biliary tract cancer (2nd line)
Topline data 2H 2019
Biliary tract cancer (1st line)
BTC (Biliary Tract Cancer)
In 2016 the prevalence of biliary tract cancer (BTC) was over 200,000 patients in Asia, compared to approximately 12,600 in the United States. BTC has a five-year survival rate of less than 10% and there has been little improvement in prognosis or treatment outcomes over the last two decades.
Though biliary tract cancer is considered to be a subset of liver cancer, therapies approved for liver cancer are not approved for biliary tract cancer. There are no therapies approved for BTC in the United States. Approximately 35% of patients undergo surgical resection, but recurrence is common, with the disease returning in 50% to 60% of patients.
Specific pathways driving BTC have not been identified, however recent data from Japan and China show that approximately 70% of BTC tumours exhibit HER family overexpression, with HER4 expressed most widely.
Varlitinib is the only pan-HER being developed in BTC. ASLAN has reported positive phase 1b data in first-line BTC that demonstrates increased activity over standard of care. Its global pivotal TreeTopp clinical trial in second-line BTC completed enrolment ahead of schedule in December 2018 and topline data is expected in the second half of 2019.
[1] As of 2016, based on Edison Investment Research, “Novel treatments for worldwide unmet needs,” dated November 8, 2017, surveying Randi et al. (2008), Epidemiology of biliary tract cancers: an update; Bridgewater et al. (2014), Guidelines for the diagnosis and management of intrahepatic cholangiocarcinoma.
Atopic dermatitis
Atopic dermatitis is the most common dermatological disease, affecting over 200 million patients worldwide. Up to one-third of adult atopic dermatitis patients are considered moderate-to-severe, for which currently available therapeutics are limited and management is challenging in the majority of cases.
ASLAN004 is a fully human monoclonal antibody that targets the IL-13 receptor α1 subunit, or IL-13Rα1, with potential to be a best-in-class therapy for atopic dermatitis. ASLAN004 is currently undergoing a phase 1 study for the treatment of atopic dermatitis. The SAD portion of the study is expected to complete in the first half of 2019.
AML (Acute Myeloid Leukemia)
The majority of the total AML population have failed on standard of care chemotherapy in AML or do not respond to chemotherapy, which are termed relapsed/refractory. In 2016, the annual incidence of relapsed/refractory patients is approximately 13,000 patients in the United States, 8,000 in Europe, 5,000 in Japan and 24,000 in China. Survival is age-dependent and survival rates are extremely poor for the elderly. The five-year relative survival rate for AML patients aged 19 years and below is 65% but declines to 50% for patients aged 20 to 49 years, and the survival rate for patients aged 65 years or older is only 6%.
The first-line treatment for patients with AML is a combination of aggressive chemotherapies. However, elderly patients with AML are typically ineligible for aggressive treatment regimens due to the significant toxicity associated with these therapies. The survival of these patients is usually less than one year. Over the past two decades, many compounds have been evaluated in AML patients, however, only three targeted drugs have been approved. Furthermore, these drugs target relatively small subsets of patients, leaving a significant unmet need.
A potent inhibitor of DHODH, ASLAN003 has a potentially differentiated safety profile and may be applicable in broad range of AML patients. Ex-vivo and in-vivo data has shown promising efficacy of ASLAN003 in AML. Recent results from an ongoing phase 2 study have shown that ASLAN003 is well-tolerated at all dose levels, with early signs of clinical activity in lower dose cohorts.