Threshold Pharma lands $20M milestone from Merck KGaA

Posted under Blog, Clinical Trials, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck KgAA, pancreatic cancer, Pharmaceuticals, Pipeline, Startups, TH-302, Threshold Pharmaceuticals, Universities, Videos by john

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

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Threshold shares spike on positive IIb data for pancreatic cancer drug

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, pancreatic cancer, Pharmaceuticals, Startups, Threshold Pharmaceuticals, Universities, Videos by John Carroll

Threshold Pharmaceuticals ($THLD) put out the word this morning that its experimental therapy TH-302 delayed the progression of advanced, aggressive pancreatic cancer by two months in a Phase IIb study, a sufficient margin of improvement to trigger a 52% hike in its stock price as shares rocketed up in minutes.

Progression-free survival rates in the low- and high-dose arms of the Phase II achieved a median 5.6 months, a 63% improvement compared to a third arm which received the standard chemotherapy gemcitabine alone. The tumor response rate hit 22% in the drug-chemo combo arms, compared to 12% in the chemo group.

That’s good news for Merck KGaA as well. The pharma giant is partnered on the therapy, which is now in Phase III. A total of 214 pancreatic cancer patients were randomized in the IIb trial. TH-302 is triggered by hypoxia,where low oxygen levels in solid tumors set the stage for the drug to begin its work. Several cancer studies testing the drug are now underway.  

"With the results of this trial, we are again very encouraged that TH-302 is conferring benefit to patients with aggressive and difficult to treat cancers," said Barry Selick, Ph.D., the CEO of Threshold. "We look forward to its ongoing development with our partner Merck KGaA in this and other indications."

- read the press release
- here's the story from TheStreet

Related Article:
Threshold, Merck KGaA strike $525M licensing deal for promising cancer drug
 

Threshold, Merck KGaA strike $525M licensing deal for promising cancer drug

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck KgAA, pancreatic cancer, Pharmaceuticals, Startups, Threshold Pharmaceuticals, Universities, Videos by John Carroll

The dealmakers at South San Francisco-based Threshold Pharmaceuticals ($THLD) have crafted a $525 million licensing pact with Merck KGaA covering its late-stage cancer drug TH-302. Threshold snagged a $25 million upfront, a promise of $35 million in near-term paydays and a $20 million reward if upcoming pancreatic cancer data come in positive. And the biotech holds on to co-promotion rights in the United States.

In its release, Threshold outlined a total of $280 million in regulatory and development milestones and $245 million in milestones based on sales.

"The addition of TH-302 to our pipeline provides an important opportunity in several different tumor types to expand our oncology development program," said Susan Jane Herbert, who's in charge of business development and strategy at Merck Serono. "Given the fact that pancreatic cancer is a very difficult to treat indication, successful Phase II results could represent important upside for our company."

Threshold is all about TH-302. The biotech has 8 clinical trials underway involving the treatment.

In addition to the Phase II pancreatic cancer study, Threshold is pushing ahead on a late-stage program for soft tissue sarcoma. The treatment is designed to be activated when it comes in contact with the low oxygen levels found in tumor tissue, zeroing in on its target with a therapeutic payload that can be delivered in combination with other treatments.

- here's the release from Threshold
- read the story from Dow Jones

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