07.07.2017 11:41:07
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Company Spotlight: Verastem
(RTTNews) - Shares of Verastem Inc. (VSTM) are up more than 48% in the past 5 trading days while the iShares Nasdaq Biotechnology Index (ETF) (IBB) is down 3.21% during the same period.
Verastem is a biopharmaceutical company focused on developing drugs to improve outcomes for cancer patients.
The Company's lead drug candidate is Duvelisib, which was licensed from Infinity Pharmaceuticals (INFI) last November.
The following two ongoing trials of Duvelisib are of specific interest.
-- A phase III monotherapy study of Duvelisib compared to GlaxoSmithKline's Arzerra (Ofatumumab) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), dubbed DUO.
-- A phase II single-arm, monotherapy study of Duvelisib in patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy, dubbed DYNAMO.
The top-line data from the DUO study are awaited. During a corporate presentation last month, the Company said that the DUO study results are expected to be presented in mid-year 2017.
In the DYNAMO study, the results of which were reported last June, Duvelisib demonstrated an overall response rate (ORR) of 46 percent, successfully meeting the trial goal, but was not as strong as Infinity, the then owner of Duvelisib, expected.
As previously mentioned, Verastem licensed exclusive worldwide rights to develop and commercialize Duvelisib from Infinity Pharma in November of 2016.
Verastem presented long-term follow-up data from the DYNAMO study in June of this year. The presentation focused on the subsets of patients with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL) enrolled in the study.
According to the Company, of the 83 patients with double-refractory FL enrolled in DYNAMO, 83% of evaluable patients treated with Duvelisib had a reduction in the size of their target lymph nodes at 18 months of follow-up. Median duration of response was 7.9 months, median progression-free survival was 8.3 months, and median overall survival was 27.8 months.
Of the 28 patients with double-refractory SLL enrolled in DYNAMO, 100% of evaluable patients treated with Duvelisib had a reduction in the size of their target lymph nodes. With a median time on Duvelisib of 12 months, median duration of response was 10.1 months, median progression-free survival was 11.7 months, and median overall survival was 28.9 months.
Another clinical drug candidate in the pipeline is Defactinib.
A phase I/II clinical trial of Defactinib in combination with investigational Avelumab in patients with advanced ovarian cancer commenced in January of 2017. The Phase 1/2 clinical trial is being conducted in collaboration with the alliance between Merck KGaA and Pfizer, and is expected to enroll approximately 100 patients at up to 15 sites across the U.S.
Recent event:
The Company reported financial results for the first quarter ended March 31, 2017 on May 10, 2017.
The net loss for Q1, 2017 widened to $13.0 million or $0.35 per share from $8.3 million or $0.22 per share in Q1, 2016. At March 31, 2017, Verastem had cash of $72.6 million and total debt of $2.25 million.
Shares of Verastem touched a new 52-week intraday high of $3.85 on Thursday (July 6, 2017) before closing the day's trading at $3.45, up 41.98%.
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