In a report published Thursday, Cantor Fitzgerald analyst Daniel Brims maintained a Buy rating and price target of $14 on Threshold Pharmaceuticals, Inc. THLD. The analyst believes that Evofosfamide and TH-4000 could be key catalysts for the stock on 2016.
Existing EGFR inhibitors are found to be effective in only about 10-25 percent of NSCLC cases with driver mutations. In addition, it has also been found that Wt EGFR could be up-regulated due to hypoxic conditions and can also be expressed with driver mutant EGFR. It is also possible that Wt EGFR plays a role in the resistance towards certain drugs.
"TH-4000 is capable of inhibiting both Wt and the escape mutant, T790M, EGFR at doses well below the MTD (suggesting a large therapeutic window). The next generation drug candidates or current EGFR inhibitors are unable to be given at sufficient doses to inhibit wt EGFR, which we believe leads to a reduced response rate and more rapid progression," Brims reported.
The analyst believes that the proposed Phase 2 studies of TH-4000 in NSCLC, as well as head and neck cancer, could help position this drug as valuable treatment option. Previous trials have demonstrated that TH-4000 is usually well tolerated even in high doses, without the severe diarrhea and rash seen typically with elotinib. This, along with other data, shows a safety profile for TH-4000 that supports clinical development.
"We believe read-out of top-line OS data in the two pivotal phase 3 trials of evofosfamide in pancreatic cancer and STS, which are expected in early 2016, will be the key catalysts for THLD and enable both FDA and EMA regulatory submissions shortly thereafter," Brims added.
The analyst expects the company to initiate Phase 2 trials for TH-4000 by mid-2015, with interim data likely to be presented in 2016.
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