Threshold Pharmaceuticals Inc.

Threshold Pharmaceuticals Inc. is a biotechnology company using its expertise in the tumor microenvironment to discover and develop therapeutic agents that selectively target tumor cells for the treatment of patients living with cancer. Threshold's lead investigational small molecule, TH-302, is being evaluated in two pivotal Phase 3 clinical trials and multiple earlier-stage clinical trials. The company has a global license and codevelopment agreement for TH-302 with Merck KGaA, with an option to co-commercialize in the United States.

Expert Comments:

Jerry Isaacson, LifeSci Advisors (1/27/15)
"Threshold Pharmaceuticals Inc. is expecting pivotal Phase 3 data with lead candidate TH-302 plus doxorubicin in first-line soft tissue sarcoma in early 2016. . .another oncology company, CytRx Corp., reported median overall survival on Jan. 22 from its Phase 2b trial, which added new historical survival data for patients receiving doxorubicin alone. . .we believe that the new results help define the significance of prior single-arm trial data with TH-302 and the potential for Phase 3 success."

"The payload for Threshold Pharmaceuticals Inc.'s TH-302 is an analog of ifosfamide, a DNA alkylating agent that has been an effective anticancer drug for decades. TH-302 has an efficient hypoxia trigger such that the drug circulates benignly, without causing issues elsewhere in the body. It penetrates hypoxia regions of a tumor, where the hypoxia microenvironment releases the ifosfamide analog, concentrating it where it can kill tumor cells that might otherwise evade most other therapeutic agents. . .[the company is in two Phase 3 trials], one in soft tissue sarcoma (STS) with doxorubicin, and the other in pancreatic cancer with gemcitabine. The STS trial is likely to play out with topline results by Q3/15 or Q4/15, and the pancreatic cancer trial by Q1/16." read more >

George Zavoico, MLV & Co (12/19/14)
"Our view [is] that Threshold Pharmaceuticals Inc.'s TH-302 is a platform in a single drug as we think it may be efficacious in multiple cancer types and is safely combinable with effective anti-tumor agents to improve clinical outcomes. We think the company stock is currently undervalued, especially since we expect interim and final results from multiple trials next year, including a pivotal Phase 3 trial in soft tissue sarcoma, which we think will add to the growing body of evidence that TH-302 is a safe and effective drug."

Jerry Isaacson, LifeSci Advisors (12/12/14)
"Threshold Pharmaceuticals Inc. announced initial data with TH-302 in combination with Velcade (bortezomib) and dexamethasone, or TBorD. . .the data, presented at the 2014 American Society of Hematology meeting indicated one very good partial response and a partial response out of four relapsed/refractory multiple myeloma patients treated at the recommended Phase 2 dose of TBorD. The data are encouraging considering the median number of prior therapies for patients was eight."

Andrew Fein, H.C. Wainwright & Co. (12/8/14)
"This weekend, at the ongoing American Society of Hematology meeting in San Francisco, Threshold Pharmaceuticals Inc. presented data from Part C of its Phase 1/2 study of TH-302 in relapsed/refractory multiple myeloma. . .in our view, if the general range of response rate seen to date with TBorD holds during the cohort expansion (we have no reason to think otherwise), we believe that regulators could be open to a pivotal study as a next step."

Charles Duncan, Piper Jaffray & Co. (12/4/14)
"Topline data from Threshold Pharmaceuticals Inc.'s Phase 3 are expected still in Q1/16; '302 is not limited to sarcoma though. Recall that pancreatic cancer data are anticipated in 2016, and management suggested that the data might be close to the sarcoma data in early 2016; the pancreatic cancer study completed enrollment three to five months ahead of schedule."

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