On August 5, 2020 AVEO Oncology (Nasdaq: AVEO) reported that it has earned a $2.8 million development milestone payment from partner Kyowa Kirin Co., Ltd. (Kyowa Kirin) (Press release, AVEO, AUG 5, 2020, View Source [SID1234562959]). The milestone relates to acceptance by the Japanese Pharmaceuticals and Medical Devices Agency of an investigational new drug (IND) application for tivozanib in a non-oncology indication being developed by Kyowa Kirin.
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"This milestone marks an important step forward for AVEO’s non-oncology pipeline," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib’s potential in non-oncology indications is significant, and we look forward to seeing Kyowa Kirin move this formulation into the clinic."
Under the terms of AVEO’s agreement with Kyowa Kirin, in addition to the previously-paid upfront payment of $25 million to AVEO and waiver of AVEO’s obligation to make an $18 million milestone payment upon AVEO gaining U.S. marketing approval of tivozanib for renal cell carcinoma, and now the IND development milestone, Kyowa Kirin has also agreed to pay AVEO up to an additional $388 million in potential milestone payments upon the successful achievement of certain development, regulatory, and commercial objectives in non-oncology indications of tivozanib. Kyowa Kirin will also be obligated to make tiered royalty payments on the net sales of a product for these indications, ranging from a high single-digit to low double-digit percent.
About Tivozanib (FOTIVDA)
Tivozanib (FOTIVDA) is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union, the United Kingdom, Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved activity and minimal dose modifications.1,2 AVEO’s TIVO-3 trial is supporting a regulatory submission in the U.S. seeking marketing approval of tivozanib as a treatment for relapsed or refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.4 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin in non-oncology indications.