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AVEO Pharmaceuticals, Inc. AVEO announced that it has regained complete global rights to ficlatuzumab from Boulder, CO-based private company Biodesix. The company plans to fund the clinical manufacturing of the candidate to conduct a potential registrational phase III study for treating head and neck squamous cell cancer (HNSCC) along with other phase II studies addressing other cancer indications.
Ficlatuzumab is a potent hepatocyte growth factor (HGF) inhibitory antibody product candidate. Previously, AVEO and Biodesix shared a worldwide agreement to develop and commercialize ficlatuzumab.
Per the latest deal, Biodesix will continue to provide 50% funding for the ongoing phase II study to treat HNSCC and will also be eligible to receive a low double-digit royalty on future product sales, if approved as well as 25% of future licensing revenues, subject to certain conditions.
Ficlatuzumab in combination with Eli Lilly’s LLY Erbitux (cetuximab) is currently being evaluated in a phase II study for addressing recurrent metastatic HNSCC by AVEO. Enrollment in the study is expected to be completed by the fourth quarter of 2020 with final data from same expected in mid-2021.
Notably, the combo of ficlatuzumab plus Erbitux was well tolerated and resulted in a disease control rate of 67% as well as a prolonged progression free and overall survival versus historical controls in a phase I study.
Shares of AVEO have declined 16.1% so far this year compared with the industry’s decrease of 2.3%.
We remind investors that in January 2020, AVEO and Biodesix presented encouraging data from a phase Ib study evaluating ficlatuzumab in combination with nab-paclitaxel and Eli Lilly’s Gemzar (gemcitabine) for addressing previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer.
This early-stage study was designed to find the maximum tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel for treating the given patient population.
Meanwhile, in March 2020, AVEO and Biodesix discontinued the phase II CyFi-2 study evaluating ficlatuzumab in combination with high-dose cytarabine versus high-dose cytarabine alone in patients with relapsed/refractory acute myeloid leukemia (AML). The decision was prompted by an urgent shift in focus of the clinical sites on making efforts to combat the coronavirus disease, COVID-19.
Zacks Rank & Other Stocks to Consider
AVEO currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the biotech sector include Emergent BioSolutions Inc. EBS and Horizon Therapeutics Public Limited Company HZNP, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have moved 83.2% and 62.6% north for 2020 and 2021, respectively, over the past 60 days. The stock has skyrocketed 93.1% year to date.
Horizon’s earnings estimates have been revised 60.6% and 56.5% upward for 2020 and 2021 each over the past 60 days. The stock has rallied 92.5% year to date.
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