August 27, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Needham, Mass.-based Verastem, Inc. released a statement yesterday in response to a big stock drop and questions regarding yet-to-be-released Phase II clinical trial data.
The drug in question is VS-6063 (defactinib), an oral compound that targets cancer stem cells by inhibiting focal adhesion kinase (FAK). FAK activity is important in helping cancer stem cells grow and survive. The company intends to release data concerning its Phase II study in patients with KRAS mutant non-small cell lung cancer (NSCLC) at the 16th World Conference on Lung Cancer (WCLC) next month, but news that two subjects in the study died and others had severe side effects have prompted Verastem to respond publicly.
“While updated results from the Phase II study of VS-6063 in KRAS mutant non-small cell lung cancer are under embargo until WCLC, Verastem believes the study has met its goals, with encouraging outcomes that the Company plans to explore in future studies,” the company stated. “The population explored in this study has refractory, advanced lung cancer, with a median of three prior therapies, and as many as eight prior therapies. The advanced stage of disease led, in some cases, to deaths even in the period between screening and prior to first dose of VS-6063. Two subjects reported as having grade 5 respiratory failure were on multiple concomitant medications and presented with multiple-comorbidities. Both were thoroughly evaluated and reported to the regulatory authorities in 2013 and 2014 when they occurred.”
The company provided general details regarding the content of the abstract, including that 35 of 52 people in the study had side effects that were possibly related to the drug. Of those 35, 11 had side effects that were classified as “severe.” Two patients died of respiratory failure.
The drug is also being studied in mesothelioma, another form of severe lung cancer.
Verastem concludes by saying “There have been over 300 patients treated to date with VS-6063, including patients on the drug for more than one year. Verastem remains encouraged by the clinical potential of targeting cancer stem cells through FAK inhibition, and is unwavering in its commitment to delivering novel, safe and effective treatments to patients with unmet medical needs.”
Apparently the initial speculation occurred on social media platform Twitter, when people began to pass the abstract around online. In an interview with FierceBiotech, Robert Forrester, Verastem’s chief executive officer, said, “It’s a little frustrating what happens in the Twittersphere.”
On the other hand, it’s been an extremely volatile week for stocks in general worldwide.
has been fairly volatile over the last year and on a downward trajectory since late March. Shares traded for $9.77 on Oct. 3, 2014, dropped to $7 on Jan. 22, 2015, and spiked on Mar. 20, 2015 to $12.10. They then started a slide, trading for $7.99 on Aug. 12. After yesterday’s Twitter speculation, shares are currently trading for $4.91.
Yesterday, analysts at Mizuho reiterated a “Buy” rating for Verastem with a $21 price target. Zacks switched from “Hold” to “Buy” on Aug. 11, setting a price target of $8.50. Cantor Fitzgerald analysts kept their rating at “Buy” and set a $22 price target on Aug. 10. And analysts at HC Wainwright issued a “Buy” rating and a $17 price target on June 29.
