On March 22, 2017 AVEO Oncology (NASDAQ:AVEO) reported financial results for the full year ended December 31, 2016 and provided a business update (Press release, AVEO, MAR 22, 2017, View Source [SID1234518237]).

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"TIVO-3, our lead clinical program designed to serve as the basis for a potential U.S. registration for tivozanib as a first- and third-line treatment for renal cell cancer, continues to enroll ahead of schedule and has now completed its first safety review," said Michael Bailey, president and chief executive officer of AVEO. "We look forward to the study’s pre-planned interim futility analysis midyear 2017 and, potentially, to top line results in the first quarter of 2018 and to initial data from our Phase 1 TiNivo study of tivozanib in combination with Opdivo in the first half of 2017. We also continue to support our partner EUSA Pharma in its efforts to complete the European Marketing Authorization Application review for tivozanib as a first-line treatment for renal cell carcinoma. There remains a significant unmet need for better tolerated therapies in this disease, particularly those that enable combination treatment, and we look forward to receiving tivozanib data and to potential regulatory milestones in the coming quarters."

Mr. Bailey continued: "We also look forward to several milestones with the balance of our pipeline, including the presentation of data from two investigator sponsored studies of ficlatuzumab, a potential partnership for AV-353, and progress toward the clinic for AV-380 and AV-203."

Recent Updates

TIVO-3 Enrolling Ahead of Schedule and Passes First Safety Monitoring Committee Safety Review; Pre-Planned Interim Futility Analysis Expected Midyear 2017. In February 2017, AVEO announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment. The Company announced just prior to the safety review that the TIVO-3 trial is enrolling substantially ahead of schedule. With the SMC recommendation to replace early dropouts, the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first-line treatment of RCC, is designed to support potential regulatory approval of tivozanib in the U.S. as a third- and first-line treatment for RCC.
First Patient Dosed in Phase 1/2 TiNivo Trial Evaluating Tivozanib in Combination with Bristol-Myers Squibb’s Opdivo (nivolumab) in Advanced RCC. AVEO announced today that the first patient has been treated in the Company’s Phase 1/2 TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in advanced RCC. The study, which is led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1, which the Company expects to complete in the first half of 2017, will primarily evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib. If the Company receives favorable results, it expects to follow immediately with an expansion Phase 2 at the established combination dose.
Ongoing Review of the Marketing Authorization Application (MAA) in Europe for Approval of Tivozanib as a First-Line RCC Treatment Option. In February 2017, AVEO announced that its European licensee for tivozanib, EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has received the Day 180 List of Outstanding Issues (LOI) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The Day 180 LOI signifies that the MAA is not approvable at the present time and outlines outstanding deficiencies, which are then required to be satisfactorily addressed in an oral explanation and/or in writing prior to a final application decision. EUSA has informed AVEO that it expects to submit written responses to the Day 180 LOI in April 2017, and the EMA has tentatively scheduled EUSA to provide an oral explanation to the CHMP in May 2017.
Submitted for Presentation Results from Phase 1 Studies of Ficlatuzumab in Combination with Cetuximab in Head and Neck Squamous Cell Cancer (HNSCC) and Cytarabine in Acute Myeloid Leukemia (AML). The Company announced today that results from two investigator sponsored Phase 1 studies of ficlatuzumab were submitted for presentation at an upcoming major medical meeting. The first study is designed to explore cetuximab in combination with ascending doses of ficlatuzumab in patients with cetuximab-refractory HNSCC patients. The second study is designed to explore cytarabine in combination with ascending doses of ficlatuzumab in relapsed/refractory AML. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab.
Full Year 2016 Financial Highlights

AVEO ended 2016 with $23.3 million in cash, cash equivalents and marketable securities as compared with $34.1 million at December 31, 2015.
Total collaboration revenue for 2016 was approximately $2.5 million compared with $19.0 million for 2015.
Research and development expense for 2016 was $23.7 million compared with $12.9 million for 2015.
General and administrative expenses for 2016 were $8.2 million compared with $14.2 million for 2015.
Net loss for 2016 was $26.9 million, or a loss of $0.39 per basic and diluted share, compared with net loss of $15.0 million for 2015, or a loss of $0.27 per basic and diluted share.
Financial Guidance

We believe that our $23.3 million in existing cash, cash equivalents and marketable securities as of December 31, 2016 could allow us to fund our planned operations into the fourth quarter of 2017; however, additional funds will be needed to extend these operations into 2018 and maintain compliance with our $10.0 million financial covenant under our loan agreement with Hercules.

On March 22, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that it has submitted its responses to the European Medicine Agency (EMA) Day 180 List of Outstanding Issues issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older (Press release, Sunesis, MAR 22, 2017, View Source [SID1234518235]).

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"Our team has provided detailed answers to the EMA in response to the Day 180 List of Outstanding Issues," said Daniel Swisher, President and Chief Executive Officer of Sunesis. "We are preparing to go before the Scientific Advisory Group’s Oncology Division (SAG-O) in April, which will assist the CHMP in its evaluation of our application. As we approach this final phase of the European approval process, anticipating a CHMP decision by mid-year, we continue to work in parallel to qualify the best pharma partner to work with us on a European market launch of vosaroxin in the second half of 2017."

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed/refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

Vosaroxin’s Marketing Authorization Application for relapsed refractory AML is currently under review by the European Medicines Agency, and a regulatory decision regarding approval is expected in 2017.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

On March 22, 2017 AVEO Oncology (NASDAQ:AVEO) reported that the first patient has been dosed in the Phase 1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in advanced renal cell carcinoma (RCC) (Press release, AVEO, MAR 22, 2017, View Source [SID1234518233]). The study, which will be led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 trial will evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib and, assuming favorable results, is expected to be followed by an expansion Phase 2 cohort at the established combination dose.

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"There is compelling scientific rationale for combining the antiangiogenic activity of VEGF inhibition with the immunologic activity of PD-1 inhibitors. Yet, to date, the tolerability of these combinations have been a challenge with currently approved VEGF TKIs and PD-1s," said Professor Escudier. "Tivozanib has been demonstrated to be the most selective VEGF inhibitor, delivering a uniquely favorable tolerability profile in past single agent and combination studies, and has the potential for minimal overlapping toxicities with immunotherapies. I look forward to understanding the clinical potential of combining tivozanib and nivolumab in the TiNivo study, and to the prospect of further improving outcomes in this very dynamic treatment area."

"VEGF-PD-1 combinations have yielded promising tumor response outcomes in renal cell cancer, yet the data presented to date point to challenging or prohibitive toxicity," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib offers a unique opportunity to potentially overcome this barrier, and look forward to initial results from the Phase 1 portion of the TiNivo trial in the first half of 2017."

About Tivozanib

Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). 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 efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.