Stock Update (NASDAQ:AVEO): AVEO Pharmaceuticals, Inc. and Biodesix Announce Results from Two Phase 1 Studies of HGF Targeted Antibody Ficlatuzumab


AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) and Biodesix announced the presentation of results from two investigator-sponsored Phase 1 studies of ficlatuzumab at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, Illinois. The first is a study of ficlatuzumab in combination with the EGFR inhibitor cetuximab in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC), and the second is a study of ficlatuzumab in combination with high-dose cytarabine in patients with high risk relapsed or refractory acute myeloid leukemia (AML). Ficlatuzumab is a humanized IgG1 antibody that binds to the HGF ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway.

“HGF is an important pathway for resistance and proliferation in a number of cancer models, serving as a means to overcome EGFR inhibition in HNSCC, and as an adverse prognostic factor in AML,” said Michael Needle, chief medical officer of AVEO. “In a Phase 1 study in patients with cetuximab-resistant recurrent/metastatic HNSCC, the addition of ficlatuzumab to the EGFR-targeted antibody cetuximab resulted in a disease control rate of 67%, and prolonged progression free and overall survival compared to historical controls, in addition to being well tolerated. With continued, strong investigator support, we look forward to the expected initiation, in the second half of 2017, of a randomized, Phase 2, multicenter, investigator-initiated trial to confirm these findings. We also look forward to the completion of the ongoing investigator-sponsored study in AML, which has demonstrated early signs of tolerability and activity, including a 50% complete response rate in the relapsed/refractory setting.”

“Median PFS for cetuximab monotherapy in the naïve setting is only two months, as with the median PFS for nivolumab or single-agent chemotherapy in the platinum-refractory setting, suggesting an urgent need for new therapies,” said Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center. “Although a small cohort, the fact that we observed significant responses and PFS of 6 months in a refractory population in this study suggests important biologic activity.”

AVEO also announced that a Trials in Progress presentation highlighting the ongoing Phase 3, randomized, controlled, multi-center, open-label TIVO-3 study comparing tivozanib, the Company’s potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, to sorafenib in subjects with refractory advanced renal cell carcinoma.

Shares of AVEO Pharmaceuticals are currently trading at $0.750, down $0.055 or -6.79%. AVEO has a 1-year high of $1.09 and a 1-year low of $0.50. The stock’s 50-day moving average is $0.65 and its 200-day moving average is $0.67.

AVEO Pharmaceuticals, Inc. operates as a biopharmaceutical company, which engages in the advancement of therapeutics for oncology and other areas of unmet medical need. Its products include Tivozanib, Ficlatuzmab, AV-203, AV-380, and AV-353. It focuses on the development of its lead candidate, Tivozanib, in North America as a treatment for renal cell carcinoma and other cancers.