AVEO Flat on New Study with EUSA

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) weakened on stock markets Wednesday morning after the company and EUSA Pharma disclosed that EUSA Pharma has opted into the Phase 1/2 TiNivo study.

A news release out Wednesday declared that, under terms of the agreement, EUSA may utilize data from the study for regulatory or commercial purposes in exchange for a research and development funding payment totalling $2.0 million. EUSA’s decision follows approval in August of tivozanib by the European Commission for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland.

The TiNivo trial is a Phase 1/2 trial of tivozanib in combination with Bristol-Myers Squibb’s OPDIVO® (nivolumab), an immune checkpoint, or PD-1, inhibitor, for the treatment of RCC. The TiNivo trial is being led by a facility in Paris.

In June, AVEO announced the advancement of the trial into the Phase 2 expansion portion following successful completion of the Phase 1 dose escalation portion. The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities.

AVEO CEO Michael Bailey said, “We look forward to working with EUSA in helping shape the future direction of FOTIVDA® in an evolving treatment landscape for advanced RCC.”

The Cambridge, Mass.-based AVEO is “a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need.”

The stock jettisoned five cents, or 1.3%, to $3.79 approaching noon ET Wednesday, within a 52-week trading range of 50 cents to $4.24.