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Leap's anti-DKK1 candidate shows positive effect in early-stage study in biliary cancer; marriage partner Macrocure up 36%

Oct. 10, 2016 11:54 AM ETLeap Therapeutics, Inc. (LPTX) StockLPTXBy: Douglas W. House, SA News Editor
  • Thinly traded nano cap Macrocure (MCUR +36.4%) jumps on almost a 15x surge in volume in response to merger partner Leap Therapeutics' announcement of encouraging results from a Phase 1 clinical trial assessing lead product candidate DKN-01, in combination with chemo agents gemcitabine and cisplatin, in patients with advanced biliary cancer. The data were presented at the European Society for Medical Oncology 2016 Annual Meeting in Copenhagen.
  • In 21 evaluable patients who received a 300 mg regimen of DKN-01 plus chemo, 33% (n=7/21) were partial responders. Additionally, the disease control rate (partial responders + those with stable disease) was 95% (n=20/21). Median progression-free survival (PFS) and overall survival (OS) have yet to be reached.
  • The combination regimen was safe and well-tolerated with no reported serious adverse events or dose-limiting toxicities.
  • DKN-01 is a humanized IgG4 monoclonal antibody that binds to Dickkopf-1 (DKK1), a protein associated with a poor prognosis in a range of cancers. Specifically, it inhibits a pathway called canonical Wnt/Beta-catenin which plays a key role in embryonic development, cell proliferation and differentiation.
  • Bile duct cancer, cholangiocarcinoma, occurs in ~6K Americans each year. The five-year survival rate is less than 10% because it is usually in an advanced stage when first diagnosed.
  • Leap and Macrocure announced their merger plans in late August.
  • Previously: Macrocure up 102% on merger with Leap Therapeutics (Aug. 29)

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