Threshold Pharmaceuticals is on a roll. The South San Francisco-based biotech ($THLD) reported this morning that Merck KGaA is handing over a $20 million milestone for a successful mid-stage study of their pancreatic cancer drug. That windfall comes just weeks after the German pharma giant forked over a $25 million upfront to partner on TH-302, which also won orphan drug status at the FDA at the end of March.
In early February, Threshold's stock rocketed up more than 50% on the news that TH-302 demonstrated positive results in a Phase IIb study. Progression-free survival rates in the low- and high-dose arms of the Phase II hit a median 5.6 months, a 63% improvement compared with a third arm, which received the standard chemotherapy gemcitabine alone. The tumor response rate hit 22% in the drug-chemo combo arms, compared with 12% in the chemo group.
That news closely followed Threshold's $525 million licensing pact with Merck KGaA, which was sweetened with $80 million in upfront and near-term milestone payments. The companies are pursuing a slate of clinical trials for the drug, which is triggered when it encounters the oxygen-starved tissue characteristic of many cancers. The most advanced of these trials is a Phase III pivotal study evaluating TH-302 in combination with doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma.
"The achievement of this milestone validates the encouraging results seen in our 404 trial," said Barry Selick, Ph.D., the CEO of Threshold. "We look forward to working in collaboration with Merck to rapidly determine next steps and move forward in this disease where few advances have been made."
- here's the press release