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AVEO

Aveo Pharmaceuticals

$2.64

-0.06 (-2.22%)

07:07
12/07/17
12/07
07:07
12/07/17
07:07

Aveo Oncology announces clinical updates to tivozanib, ficlatuzumab programs

AVEO Oncology announced clinical updates for two of its oncology programs: FOTIVDA, the company's potent, selective, long half-life inhibitor of all three vascular endothelial growth factor receptors, and ficlatuzumab, the company's humanized IgG1 antibody that binds to the hepatocyte growth factor ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway. AVEO announced that enrollment of 21 patients is now complete, with one patient remaining in screening, in the Phase 2 portion of the TiNivo study, a Phase 1/2 multicenter trial of tivozanib in combination with Bristol-Myers Squibb's OPDIVO, an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced RCC. In the Phase 1 dose escalation portion of the trial, tivozanib was administered in two escalating dose cohorts, 1.0 and 1.5 mg daily, in combination with nivolumab at 240 mg every 2 weeks. Phase 1 data from the study, which were presented at the 16th International Kidney Cancer Symposium, demonstrated that the combination of Opdivo and tivozanib was well tolerated up to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The company announced the initiation of an investigator-sponsored randomized, multicenter Phase 2 trial of ficlatuzumab and cetuximab, an EGFR-targeted antibody, in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma. AVEO is partnered with Biodesix, Inc. on the developments of ficlatuzumab. The study will seek to confirm findings from a Phase 1 study where the addition of ficlatuzumab to 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. This Phase 2 multi-center study, which is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center, is expected to enroll approximately 60 patients randomized to receive either ficlatuzumab alone or ficlatuzumab and cetuximab. The company announced the initiation of an investigator-sponsored Phase 1b study to test the safety and tolerability of ficlatuzumab when combined with Nab-paclitaxel and Gemcitabine in previously untreated metastatic pancreatic ductal cancer. The goal of the study, which is based on preclinical findings demonstrating a synergistic effect of these drugs in a preclinical model of PDAC, is designed to determine maximum tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel. Secondary outcome measures include response rate and progression free survival. The study, which is being conducted under the direction of Kimberly Perez, M.D. at the Dana-Farber Cancer Institute, is expected to enroll approximately 30 patients.

AVEO Aveo Pharmaceuticals
$2.64

-0.06 (-2.22%)

11/13/17
11/13/17
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Party City (PRTY) assumed with an Overweight at JPMorgan. 2. MongoDB (MDB) was initiated with a Buy at Stifel and Canaccord, an Overweight at Barclays, an Equal Weight at Morgan Stanley, a Market Perform at JMP Securities, and a Neutral at Goldman Sachs. 3. Arista Networks (ANET) initiated with a Neutral at Piper Jaffray. 4. NetScout (NTCT) initiated with an Overweight at Piper Jaffray. 5. Aveo Oncology (AVEO) initiated with a Buy at B. Riley FBR. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
11/13/17
RILY
11/13/17
INITIATION
Target $5
RILY
Buy
Aveo Oncology initiated with a Buy at B. Riley FBR
B. Riley FBR analyst Madhu Kumar started Aveo Oncology with a Buy rating and $5 price target. The analyst sees the company's lead asset, vascular endothelial growth factor receptor tyrosine kinase inhibitor Fotivda, being successful in the pivotal Tivo-3 trial reading out in Q1 of 2018. He views the drug as undervalued.
10/06/17
GHSC
10/06/17
INITIATION
Target $7
GHSC
Buy
AVEO Oncology initiated with a Buy at Seaport Global
Seaport Global analyst Vernon Bernardino initiated AVEO Oncology with a Buy and $7 price target.
08/28/17
PIPR
08/28/17
NO CHANGE
Target $4.5
PIPR
Overweight
AVEO Oncology price target raised to $4.50 from $3.50 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised Overweight rated AVEO Oncology's price target to $4.50 from $3.80 following approval by the European Commission for tivozanib in Europe to treat first-line renal cell carcinoma.

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