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Threshold Pharmaceuticals Inc (THLD) - Medical Equipment - Deals and A...
Summary Threshold Pharmaceuticals Inc (Threshold) is a biotechnology company that discovers and develops tumour-targeted therapies. The company’s clinical pipeline includes TH-CR-406, MAESTRO, TH-CR-413, TH-CR-408, TH-IST-4003, TH-IST-4004, TH-CR-410, TH-CR-407 and TH-IST-4001. Its products include evofosfamide, TH-4000 and [18F]-HX4. Threshold’s evofosfamide and TH-4000 are under evaluation for the treatment of a variety of tumor types. Threshold offers evofosfamide is a investigational hy...
Update: Big in Japan?
Following analysis of the Phase III data of evofosfamide (TH-302) in unresectable or metastatic pancreatic cancer patients, which failed on an intent-to-treat basis (p=0.0588), Threshold Pharmaceuticals has announced that the drug seemed to demonstrate impressive efficacy among the patients in Japan. Overall survival in the Japanese subset was 13.6 months vs 9.1 months in the control arm (p=0.0106). The company is currently seeking a partner in Japan and reaching out to the Pharmaceutical and Me...
Flash note: Disappointing Phase III evofosfamide data
Evofosfamide has not met the primary endpoint of improving overall survival in two Phase III trials in soft tissue sarcoma (STS) and pancreatic cancer. Although some benefit was seen in pancreatic cancer, partner Merck KGaA will not file either indication with regulators and Threshold expects Merck to terminate the agreement. If this occurs, Threshold will consider all options for future evofosfamide development, which could include in combination with checkpoint inhibitors. We have placed our v...
Update: Tarloxotinib advances into two Phase II trials
Tarloxitinib (TH-4000), Threshold’s earlier-stage hypoxia asset, has now started two Phase II studies, as planned. With active development now ongoing we include an indicative valuation for this asset in our rNPV, which has increased to $1,023m ($14.3/share). Tarloxotinib broadens and diversifies Threshold’s pipeline beyond evofosfamide, where we continue to expect the number of events needed for analysis of the Phase III STS and pancreatic trials should be reached in H215, with data shortly...
Update: Broadening hypoxia focus with TH-4000
Preclinical and Phase I data on Threshold’s newest hypoxia asset TH-4000 were recently presented at AACR. Threshold now plans to move TH-4000 into Phase II trials in both lung and head and neck cancers. At this stage we do not formally include TH-4000 in our unchanged $949m valuation, although TH-4000 could address sizeable markets with often limited treatment options. The major catalysts for Threshold remain related to evofosfamide, where the number of events needed for analysis of the Phase ...
Initiation: On the threshold of a blockbuster opportunity
Phase III data for evofosfamide (TH-302) in soft tissue sarcoma (STS) and pancreatic cancer are expected by early 2016. These two indications alone could lead to blockbuster sales with partner Merck KGaA. Our estimates suggest the current market cap is more than underpinned by the risk-adjusted potential in STS together with net cash. We value Threshold at $949m based on evofosfamide in STS and pancreatic cancer and in a number of further opportunities in other solid tumours and blood cancers.
QuickView: TH-302 Phase II GBM plans confirmed
Additional interim data from the ongoing Phase I/II investigator-led trial of Threshold’s TH-302 in glioblastoma (GBM) have been reported at the SNO (society for neuro-oncology) conference. Based on the early signs of efficacy observed, with survival exceeding historic reference data, plans for an investigator-led, two-centre Phase II trial have now been confirmed, supported by an FDA grant. GBM could be an indication eligible for accelerated development, given the unmet medical need.
QuickView: Pivotal STS Phase III continues as planned
The conclusion of the interim efficacy and safety analysis of Threshold’s ongoing Phase III soft tissue sarcoma (STS) trial is for the study to continue as planned, in line with both our and management’s expectations. Based on the current event rate, the number of events (n=434 deaths) required for the primary efficacy analysis are expected to be reached in H215. STS could be the first approved indication for TH-302.
QuickView: STS Interim Analysis Preview
During September the planned interim analysis of the ongoing Phase III soft tissue sarcoma (STS) trial is expected to occur. An independent committee (IDMC) will review efficacy and safety to determine next steps. Of the three possible outcomes, Threshold believes the most likely is that the trial continues as planned with overall survival data then in H215e.
QuickView: Moving TH-302 forwards in lung cancer
Threshold and partner Merck KGaA have initiated a large Phase II trial investigating TH-302 as second-line treatment for lung cancer. This follows earlier-stage data where TH-302 in combination with Alimta (pemetrexed) achieved 14.9 month overall survival (OS). This lung cancer trial bolsters TH-302’s late-stage development opportunities, which also include Phase III programmes in soft tissue sarcoma and pancreatic cancer, in addition to earlier-stage indications, including other solid tumour...
QuickView: Further encouraging data at ASCO
Updated and detailed TH-302 Phase I/II glioblastoma (GBM) and Phase I/II multiple myeloma (MM) data were presented at ASCO, with investigators highlighting the early signals of clinical activity in each of these indications. Both of these disease settings could potentially be eligible for accelerated development, given the unmet medical need, with seemingly limited value ascribed to either at current levels.
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