Singapore-based cancer and autoimmune biotech ASLAN Pharmaceutical said it has won clinical trial approval nods in Singapore and Taiwan for Phase II work on ASLAN001 (varlitinib) in second-line cholangiocarcinoma, or aggressive bile duct cancer, marking stepped-up activity for a candidate that recently obtained U.S. FDA orphan designation.
The trial to assess the efficacy of ASLAN001 also comes after a better-than-expected therapeutic responses earlier this year in which one bile duct cancer patient showed 87% tumor shrinkage over a prolonged period of time.
"Earlier studies have shown ASLAN001 to be efficacious as both monotherapy and in combination with chemotherapy in cholangiocarcinoma," ASLAN said in a press release. "This (Phase II) study will further evaluate its efficacy in a larger group of patients. ASLAN001 received Orphan Drug Designation from the U.S. FDA in August 2015."
Also earlier this year, ASLAN signed an understanding with the National Cancer Centre of Singapore (NCCS) to study novel combination therapies to treat gastric cancer, hepatocellular carcinoma and cholangiocarcinoma to explore wider avenues for its existing clinical trial candidates.
In March, ASLAN said positive Phase I results with gastric cancer candidate ASLAN002, licensed from Bristol-Myers Squibb ($BMY) (BMS-777607), will lead to Phase II trials in Asia-Pacific with the small-molecule dual inhibitor of the cMET receptor tyrosine kinase and RON immune checkpoint.
ASLAN002 was dose-escalated in 39 solid tumor patients for a minimum of 28 days as both once daily and twice daily dose regimens, the company said in an earlier press release.
The company also has ASLAN003, a DHODH inhibitor licensed from Almirall, currently in Phase I trials for rheumatoid arthritis, and ASLAN004, a fully human monoclonal antibody against interleukin-13 receptor α1 that has been shown to block binding and signal transduction of both IL4 and IL13 and licensed from CSL (CSL334). It is in preclinical development.
Last year, ASLAN secured $22 million in Series B financing led by Shanghai-based Cenova Ventures, which joined Morningside Group and XinChen Ventures with BioVeda Capital and Sagamore Bioventures, to fund ongoing clinical development of ASLAN's portfolio.
Sources said the company is eyeing raising more capital and eventually listing in either Asia or the U.S.
- here's the release (PDF)