Singapore-based ASLAN Pharmaceuticals has notched a first in its efforts to develop immunotherapies and targeted agents for Asia-prevalent tumor types under a refined cost model, roping in South Korea's Hyundai Pharmaceutical in the first co-development agreement on ASLAN001.
In September, ASLAN won clinical trial approval nods in Singapore and Taiwan for Phase II work on ASLAN001 (varlitinib) in second-line bile duct cancer, cholangiocarcinoma (CCA), marking stepped-up activity for a candidate that recently obtained the U.S. Food and Drug Administration's (FDA) orphan designation. Earlier this year, ASLAN announced better-than-expected therapeutic responses for the candidate in which one bile duct cancer patient showed 87% tumor shrinkage over a prolonged period of time.
For Hyundai, access to the candidate is aimed at getting South Korean approval for clinical trials by the end of the year to study the efficacy of the drug to treat CCA. Hyundai will pay ASLAN unspecified upfront fees and development milestones and royalties on sales upon successful commercialization of ASLAN001.
It also gets first rights of negotiation to develop the candidate in gastric and breast cancer treatment in South Korea, according to a press release. ASLAN retains co-marketing rights to ASLAN001 in South Korea.
"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," ASLAN said in the release.
ASLAN said its own development of ASLAN001 in a Phase IIA/B study started at the end of last year for second-line metastatic breast cancer across Asia continues apace.
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| Aslan CEO Carl Firth |
"This agreement underscores our focus and commitment to transforming the treatment of Asia prevalent cancers," Carl Firth, CEO and founder of ASLAN, said in the release. "The prevalence of diseases such as gastric cancer and cholangiocarcinoma is higher in South Korea than many other parts of the world, creating a high unmet need for more effective treatments."
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.
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 licensed from CSL (CSL334) that has been shown to block binding and signal transduction of both IL4 and IL13 and. 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., possibly via a Nasdaq listing.
- here's the release from ASLAN