On April 30, 2020 AVEO Oncology (NASDAQ: AVEO) reported financial results for the first quarter ended March 31, 2020 and provided a business update (Press release, AVEO, APR 30, 2020, View Source [SID1234556823]).
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"Our recent submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for tivozanib as a treatment for relapsed or refractory renal cell carcinoma (R/R RCC) is both an important milestone and a significant achievement for AVEO," said Michael Bailey, president and chief executive officer of AVEO. "There is no current standard of care for the third+ line R/R RCC population and, prior to TIVO-3, there was no robust clinical dataset to support treatment choice. If approved, we believe tivozanib has the opportunity to address this meaningful and growing segment of treatment. We look forward to the presentation of results from the final TIVO-3 overall survival (OS) analysis as we continue to build on our foundation for commercial readiness."
"In addition, our clinical and business development teams’ attention is turning toward opportunities to expand tivozanib-immunotherapy combination studies that build on the TiNivo and DEDUCTIVE trials in RCC and HCC, where we believe tivozanib’s safety and activity profile could make it a companion TKI of choice. We also remain committed to advancing the balance of our pipeline, which includes ficlatuzumab, currently in an ongoing randomized Phase 2 trial in head and neck cancer (HNSCC) which, with a favorable outcome, could characterize a potential registration path, and AV-380, for which we look forward to filing an IND in the second half of 2020," continued Mr. Bailey.
Tivozanib Updates
Final Overall Survival Analysis from the Phase 3 TIVO-3 Trial of Tivozanib in RCC to be Presented at the ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Program. Data from the final OS analysis from AVEO’s pivotal Phase 3 TIVO-3 trial comparing tivozanib, the Company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor, to sorafenib in 3rd and 4th line renal cell carcinoma, will be presented at the ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Program. The presentation, titled, "TIVO-3: Final OS analysis of a phase III, randomized, controlled, multicenter, open-label study to compare tivozanib to sorafenib in subjects with metastatic renal cell carcinoma (RCC)" (abstract 5062) will be featured during a poster session (Genitourinary Cancer – Kidney and Bladder). A copy of the poster will be available at the ASCO (Free ASCO Whitepaper) virtual meeting and on the AVEO website Friday, May 29, 2020, at 8:00 AM ET.
Submitted an NDA to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory RCC and Results of Final TIVO-3 OS Analysis Expected by June. In March 2020, AVEO announced the submission of an NDA to the U.S. FDA seeking marketing approval for tivozanib as a treatment for relapsed or refractory RCC. As previously announced, a final OS analysis of the study will be conducted in the second quarter based on a May 1, 2020 data cutoff date. AVEO expects to report results from the final OS analysis by June 2020. The FDA and the Company agreed that if, during the review, the final analysis yields an OS HR above 1.00, the Company will withdraw its NDA.
Announced Publication of Phase 1b/2 Trial of Tivozanib in Advanced, Inoperable Hepatocellular Carcinoma (HCC) in the British Journal of Cancer. In February 2020, AVEO announced the publication of results from a monotherapy trial of tivozanib in patients with advanced, inoperable HCC in the British Journal of Cancer. 27 patients were enrolled in the trial that sought to evaluate the safety, dosing, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of tivozanib in patients with advanced HCC. The recommended Phase 2 dose (RP2D) was determined to be 1.0 mg once daily for 21 days followed by 7 days off treatment on a 28-day cycle. Median PFS and OS were 24 weeks and 9 months, respectively, for patients treated at the RP2D, with an overall response rate of 21%. A significant decrease in soluble plasma VEGFR-2 was also observed, suggesting adequate target engagement. The link to this publication is available on the Publications & Presentations section of AVEO’s website.
Ficlatuzumab Updates
Presented Results from Phase 1b Trial of Ficlatuzumab, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer. In January 2020, AVEO and Biodesix, Inc. announced the presentation of results from an investigator-sponsored Phase 1b trial of ficlatuzumab, AVEO’s potent hepatocyte growth factor inhibitory antibody product candidate, in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. The results were presented during a poster session at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium.
A total of 24 patients were enrolled. The average number of 28-day cycles received was 7.5 (range 1-15), with 3 patients remaining on active treatment at the end of the trial. The combination was associated with a promising durable response rate relative to data observed for gemcitabine and nab-paclitaxel alone. This included a 29% partial response (PR) rate and 92% rate of disease control (PR + stable disease). Treatment with this regimen was associated with significant hypoalbuminemia and edema, and therefore a follow up safety study is under consideration of ficlatuzumab in combination with an alternate cytotoxic regimen. A copy of the presentation is available in the Publications & Presentations section of AVEO’s website.
CyFi-2 Study of Ficlatuzumab in Relapsed and Refractory AML Discontinued. In March 2020, AVEO and Biodesix, Inc. announced the discontinuation of their Phase 2 CyFi-2 study of ficlatuzumab in combination with high-dose cytarabine in relapsed and refractory AML. The decision was made due to the urgent shift among clinical sites toward efforts to combat the COVID-19 pandemic, which has impacted the feasibility of completing the study within the shelf-life of the current ficlatuzumab clinical trial supply.
Recent Corporate Updates
Announced New Corporate Headquarters. AVEO reported that it recently relocated its headquarters from Cambridge, Massachusetts to Boston. The new headquarters will lower overall costs and support further growth as the Company continues to execute on its tivozanib development strategy and advance the balance of its pipeline.
Building out Foundation for Commercial Readiness. As part of the build-out of its commercial organization ahead of the potential launch of tivozanib in R/R RCC, AVEO recently announced the appointment of key commercial and medical affairs leadership, including Jason Noto, Vice President of Market Access; Kevin Peacock, Vice President of Marketing; and Daniel Powers, D.O., Vice President of Medical Affairs. The commercial organization has begun additional recruitment efforts in medical affairs, market access and patient access contingent on the near-term OS update from the TIVO-3 trial.
First Quarter 2020 Financial Results
AVEO ended Q1 2020 with $33.6 million in cash, cash equivalents and marketable securities as compared with $47.7 million at December 31, 2019.
Total revenue for Q1 2020 was approximately $0.8 million compared with $1.6 million for Q1 2019.
Research and development expense for Q1 2020 was $7.8 million compared with $6.8 million for Q1 2019. Research and development expense in Q1 2020 includes the $2.9 million application user fee pursuant to the FDA’s Prescription Drug User Fee Act that was paid upon the submission of the tivozanib NDA to the U.S. FDA in March 2020.
General and administrative expense for Q1 2020 was $3.7 million compared with $2.5 million for Q1 2019.
Net loss for Q1 2020 was $8.4 million, or net loss of $0.52 per basic and diluted share, compared with net income of $0.6 million for Q1 2019, or net income of $0.04 and net loss of $0.62 per basic and diluted share, respectively.
The Company recognized approximately $2.6 million and $8.8 million in non-cash gains in Q1 2020 and Q1 2019, respectively, that were attributable to the decrease in fair value of the 2016 private placement warrant liability that principally resulted from decreases in the stock price that occurred within each of the periods.
Financial Guidance
AVEO believes that its cash, cash equivalents and marketable securities of approximately $33.6 million at March 31, 2020, along with anticipated partnership payments from cost sharing obligations and royalty revenues from sales of FOTIVDA by EUSA, would allow the Company to fund its planned operations into the second quarter of 2021.
About Tivozanib (FOTIVDA)
Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union, the United Kingdom, Norway, New Zealand and Iceland. 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.1,2 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.
About Ficlatuzumab
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in a clinical study of patients with squamous cell carcinoma of the head and neck (HNSCC).