May 12, 2017
By Alex Keown, BioSpace.com Breaking News Staff
AUSTIN, Texas – More troubles continue for cancer drugmaker XBiotech . Shares dropped about 10 percent Thursday after news broke that Kelly Thornburg, senior vice president of operations, submitted his resignation on May 5 and immediately left the company.
The sudden departure was first reported by Adam Feuerstein in The Street. In its 10-Q filing, submitted to the U.S. Securities and Exchange Commission on May 10, the company provided no reason for Thornburg’s departure. Thornburg spent two years at XBiotech following a 15 year stint at Amgen . He was hired by XBiotech for his abilities in pharmaceutical operations and drug manufacturing, Feuerstein reported.
Thornburg’s departure came after a disastrous April for XBiotech. Most recently, the European Medicines Agency gave a preliminary rejection of its colorectal cancer drug Xilonix. During an “oral explanation meeting,” XBiotech gave a 20 minute presentation to the EMA, but the data presented was not strong enough to sway the EMA at the time. In an April 21 statement, XBiotech said the key issues for the EMA “are related to clinical relevance of the therapy in the indication and quality assurance related matters.” John Simard, president and chief executive officer of XBiotech, said the company believes the findings from a Phase III trial demonstrates the efficacy of its colon cancer therapy. He said the company could appeal.
XBiotech called Xilonix the first monoclonal antibody to “specifically target and neutralize interleukin-1 alpha (IL-1a), one of the most potent inflammatory signaling molecules.” The IL-1 pathway is believed to be a desirable target for anti-cancer therapy due to its potential role in both local and systemic effects of cancer.
This isn’t the first problem with Xilonix. Last year, a European regulator raised questions about the findings in that Phase III trial and called Xilonix an unreliable drug. Feuerstein also criticized the Phase III data last year, saying the company’s data was “clinically meaningless sleight of hand.”
In addition to problems with Xilonix, a staph infection treatment developed by the company also failed during a Phase I/II trial. The company said its proprietary 514G3 antibody was not powered to demonstrate statistically significant outcomes. One of the more concerning problems with the study was that four patients who received the drug died, while none of the placebo patients did. The trial included 52 patients. Three of the deaths were considered to be unrelated to the study drug, the company said, but one of the deaths may have been, according to the trial reviewers. Despite the problems with the trial, the company attempted to put a positive spin on things, saying that 514G3 “shows promise as an innovative adjunctive approach” in treating serious staph infections.
Although XBiotech shares dropped Thursday, the stock is up this morning, trading at $9.18 as of 10 a.m. Although share prices are still significantly down from the $17.17, it was trading at before the company’s April problems began.
