After a two year absence, Aveo returned to the halls of the key event with a drug newly approved for use in Europe and possibly poised for approval in the U.S.
After two years of being excluded from the annual J.P. Morgan Healthcare Conference, Aveo Oncology returned to the halls of the key event with a drug newly approved for use in Europe and possibly poised for approval in the United States.
Last year, the European Medicines Agency approved Fotivda (tivozanib) as a first line treatment of adult patients with advanced renal cell carcinoma (aRCC). The drug was also approved in Europe for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy. At J.P. Morgan last week, Aveo Chief Executive Officer Michael Bailey told the Boston Globe that the company maintained faith in “tivo” despite several failures.
“The reason ‘tivo’ is the focus of our strategy is because we knew the drug worked,” Bailey told the Globe.
Tivozanib is an oral selective inhibitor of vascular endothelial growth factor (VEGH). It was approved in Europe based on clinical data that showed aRCC patients treated with the drug saw greater progression free survival rates than those compared to a competing VEGFR-TKI treatment (sorafenib).
While it may have new life, the drug and company have both gone through some trying times over the past several years. Aveo began developing the drug in 2006. Over the course of its development, the U.S. Food and Drug Administration raised concerns over its trial design and ultimately rejected it in 2013.
In 2016, Aveo was slapped with a $4 million fine to settle complaints the company misled investors about concerns raised by U.S. regulatory bodies about the company’s kidney cancer drug, Tivozanib. The U.S. Securities and Exchange Commission said Aveo concealed investors from concerns raised by the U.S. Food and Drug Administration about the drug. Those fines were handed down after Tivozanib failed a crucial trial that forced the company to lay off nearly 300 employees in a restructuring. The FDA requested a secondary trial to address concerns about patient death rates during the first trial. The company never conducted a second trial and the FDA declined to approve Tivozanib.
While Bailey appears confident that the FDA could finally approve Tivozanib following the potential filing of a New Drug Application, Aveo Oncology has also been working on its cash flow issues to keep the company operational through another year. Earlier this month, the company completed the refinancing of its existing $20 million debt facility with Hercules Capital that provided an additional $12.1 million to cash flow for this year, the company said.
Before the J.P. Morgan conference, Bailey said in a statement that 2018 is “expected to be another transformative year.” This year the company anticipates top-line results in the TIVO-3 study of tivozanib in third line advanced renal cell carcinoma (RCC). That is the program the company hopes will lead to regulatory approval in the United States. Additionally, Aveo said it will advance development of earlier-stage programs, including the TiNivo study of tivozanib in combination with Opdivo and the initiation of two ficlatuzumab investigator-sponsored studies.
