AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) announced updates on clinical development for FOTIVDA® (tivozanib), the Company’s potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, and ficlatuzumab, the Company’s humanized IgG1 antibody that binds to the hepatocyte growth factor (HGF) ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway.
- Enrollment Complete in Phase 2 Portion of Phase 1/2 TiNivo Trial in Advanced RCC. AVEO announced today 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® (nivolumab), 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 (n=6).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 (1.5 mg daily), with no dose limiting toxicities. The most common adverse events (any grade) were hypertension, asthenia and decreased appetite. No grade 4 adverse events were reported. Two grade 3 events were reported beyond cycle 1 (stomatitis and increased ALT), which did not lead to study discontinuation and were managed concurrently. Best response at the time of presentation included a 67% (4/6) partial response (PR) rate and a 100% disease control rate (4 confirmed PR + 2 stable disease, 1 of which was unconfirmed). Additional results from the Phase 1 portion of the trial and initial results from the Phase 2 portion are expected to be presented at scientific meetings in the first half of 2018, including at the 2018 Genitourinary Cancers Symposium taking place February 8-10, 2018, and co-sponsored by the American Society of Clinical Oncology.
- Phase 2 Study of Ficlatuzumab in Combination with Cetuximab in HNSCC Initiated. The Company announced today the initiation of an investigator-sponsored randomized, multicenter Phase 2 trial of ficlatuzumab and cetuximab (ERBITUX®), an EGFR-targeted antibody, in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC). 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.
- Phase 1b Study of Ficlatuzumab in Combination with Gemcitabine and Nab-paclitaxel in Pancreatic Cancer Initiated. The Company announced today 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 (PDAC). 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 CEO Michael Bailey stated, “We continue to build strong momentum in our oncology programs, including progress with our lead program, tivozanib, and the advancement of our other oncology programs, including ficlatuzumab and AV-203 […] With approval of tivozanib and commercial sales underway in Europe, we are squarely focused on the next two pillars of our tivozanib strategy: the potential for U.S. registration and additional immunotherapy combination studies. As these strategies unfold, 2018 is expected to be another transformative year, with anticipated top-line results in the TIVO-3 study of tivozanib in third line advanced renal cell carcinoma (RCC), as well as development of our earlier-stage programs, including the TiNivo study of tivozanib in combination with Opdivo®, and the initiation of two ficlatuzumab investigator-sponsored studies.”
Shares of AVEO Pharmaceuticals closed yesterday at $2.64, down $0.06 or -2.22%. AVEO has a 1-year high of $4.24 and a 1-year low of $0.50. The stock’s 50-day moving average is $2.98 and its 200-day moving average is $2.68.
On the ratings front, AVEO stock has been the subject of a number of recent research reports. In a report issued on November 16, B.Riley FBR analyst Madhu Kumar reiterated a Buy rating on AVEO, with a price target of $5, which represents a potential upside of 89% from where the stock is currently trading. Separately, on October 6, Seaport Global’s Vernon Bernardino initiated coverage with a Buy rating on the stock and has a price target of $7.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Madhu Kumar and Vernon Bernardino have a yearly average return of 27.3% and a loss of -9.3% respectively. Kumar has a success rate of 61% and is ranked #304 out of 4721 analysts, while Bernardino has a success rate of 25% and is ranked #4641.
AVEO 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.