Shares of Cambridge, Mass.-based AVEO Oncology have taken a wild ride over the past day. The stock skyrocketed more than 45 percent Wednesday on rumors of a possible acquisition. However, overnight and in premarket trading, the stock has lost about 5 percent of its gains.
Rumors swirled across the Internet Wednesday that pharma giant AstraZeneca was planning a potential bid for Aveo. The rumors were first reported by Seeking Alpha, which cited a hedge fund management company’s blog post that appears to have since been removed. The information cited by Seeking Alpha speculated that the U.K.-based AstraZeneca planned to make a bid for Aveo sometime in the second quarter. The goal of the deal might possibly be Aveo’s kidney cancer drug, Tivozanib.
The two companies are already collaborating on a cancer treatment with Tivozanib and AstraZeneca’s checkpoint inhibitor Imfinzi. In December, the companies struck a deal to combine the medications as a potential first-line treatment for hepatocellular carcinoma, a type of liver cancer. The companies announced they would initiate a Phase I/II trial for the combination treatment, with the Phase I portion expected to begin sometime this year. At the time the deal was announced, Michael Bailey, president and chief executive officer of Aveo, said the company’s goal was to “establish tivozanib as the TKI of choice for use with immunotherapies by demonstrating efficacy with reduced toxicity.”
That goal, however, hit a slight delay earlier this year. In January, Aveo announced that the U.S. Food and Drug Administration recommended the company not seek regulatory approval of Tivozanib until the company had “more mature” results regarding overall survival (OS) in patients. In its recommendation to Aveo earlier this year, the FDA indicated that the preliminary OS results do not allay their concerns about the potential detriment in OS, which were cited in a Complete Response Letter issued June 6, 2013. That news caused shares of Aveo stock to plunge about 45 percent.
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During the Phase III study, Tivozanib met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival. However, a preliminary analysis of the secondary endpoint of overall survivability showed a hazard ratio greater than one. The OS concerns caused the company to delay its planned New Drug Application with the FDA until the fourth quarter of this year, Aveo said in January.
That delay in the NDA sparked a potential class-action lawsuit. The lawsuit, filed by the Rosen Law Firm, seeks to recover damages for Aveo investors under the federal securities laws. The lawsuit claims that Aveo misled shareholders because its trial design did not address the overall survival concerns raised by the FDA in 2013. In November 2018, David Johnston, the former chief financial officer of Aveo, was found guilty of misleading investors about the company’s kidney cancer drug. Johnston misled investors in the company about the likely approval of the kidney cancer drug, despite the 2013 concerns raised by the FDA. In 2016, Aveo was forced to pay a federal fine of $4 million to settle similar complaints.
Aveo’s Tivozanib is a vascular endothelial growth factor tyrosine kinase inhibitor. It has been approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland and is sold under the name Fotivda.
Date: April 01, 2019
Source: BioSpace
