On January 7, 2021 AVEO Oncology (Nasdaq: AVEO) reported its recent progress and outlined its 2021 outlook (Press release, AVEO, JAN 7, 2021, View Source [SID1234573650]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We remain keenly focused on building out our commercial team ahead of the potential U.S. launch of tivozanib as a treatment for relapsed or refractory renal cell carcinoma (RCC), including the addition of Dr. Corinne Epperly to our Board of Directors," said Michael Bailey, president and chief executive officer of AVEO. "If approved, we believe tivozanib has the potential to serve as a new treatment for the rapidly growing population of patients with relapsed or refractory RCC. In support of the further clinical and commercial development of tivozanib, we have identified opportunities to potentially extend its patent exclusivity period."
Mr. Bailey added: "In addition to our launch preparation, we continue to make great progress advancing our clinical pipeline, with each asset expected to reach an important milestone this year. These include progress in our immunotherapy combination programs for tivozanib, a decision on whether to initiate a pivotal study of ficlatuzumab in head and neck squamous cell carcinoma (HNSCC), and the execution of our Phase 1 study of AV-380. We believe 2021 will be a transformational year for AVEO, and we look forward to delivering on a number of milestones designed to enhance our long-term value."
Key Recent Program Updates and Anticipated 2021 Milestones
Tivozanib U.S. Regulatory and Commercial Updates
Commercial Readiness Nearing Completion in Support of Potential Tivozanib U.S. Launch. Commercial preparations are well underway to support the potential U.S. launch of tivozanib, AVEO’s vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) drug candidate, as a treatment for relapsed or refractory RCC. U.S. sales leadership, sales training, marketing, market access and medical affairs teams as well as distribution capabilities are now in place. Hiring, training, and deployment of the Company’s field sales organization is on track for completion ahead of the U.S. Food and Drug Administration’s (FDA) New Drug Application Prescription Drug User Fee Act target action date for tivozanib of March 31, 2021.
Relapsed/Refractory RCC Disease Awareness Website Launched for U.S. Healthcare Professionals. The Company reported the recent launch of www.ReimagineRCC.com, a relapsed/refractory RCC disease awareness resource for U.S. healthcare professionals highlighted by the headline: "After multiple prior treatments in renal cell carcinoma (RCC), the journey can quickly become a challenge". The website highlights the need for more robust data and better tolerated treatment options to support the roughly half of patients who receive second line therapy yet do not continue therapy beyond progression.
Corporate Updates
Updated IP Strategy Offers Potential for Tivozanib Patent Term Extension to November 2028. AVEO holds an exclusive license to two issued U.S. patents for tivozanib, one pertaining to the tivozanib composition of matter, which expires in April 2022, and the other pertaining to a crystalline form of tivozanib, which expires in November 2023. A patent term extension of up to five years may be available under the Hatch-Waxman Act, although only one patent can be extended under the Act. The Company currently intends to file applications for patent term extension on both patents in parallel to provide optionality in its exclusivity strategy. Depending upon which patent the Company ultimately chooses to extend, if a full five year extension is granted for such patent, tivozanib’s exclusivity period could reach either April 2027 or November 2028.
Corinne D. Epperly, MD, MPH Appointed to Board of Directors. AVEO reported the appointment of Corinne D. Epperly, MD, MPH, to its Board of Directors. Dr. Epperly brings over 15 years of experience in oncology as a physician and scientist, blending medicine and business with a proven track record in oncology drug development and launches, commercial and medical strategy, marketing, M&A, and operations gained at Iovance Biotherapeutics, VBL Therapeutics, Bristol Myers Squibb, Goldman Sachs, and the National Cancer Institute of the NIH.
Tivozanib Immuno-Oncology Updates
Results from Phase 1b/2 TiNivo Study of Tivozanib in Combination with OPDIVO (nivolumab) in RCC Published in Annals of Oncology. In November 2020, AVEO announced that previously reported results from the Phase 1b/2 TiNivo study of oral (PO) tivozanib (FOTIVDA) in combination with intravenous (IV) nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced RCC, were published in Annals of Oncology. The article, titled "TiNivo: Safety and Efficacy of Tivozanib-Nivolumab Combination Therapy in Patients with Metastatic Renal Cell Carcinoma", is available online first via this link. AVEO plans to detail next steps in its investigations of the tivozanib-nivolumab combination following potential FDA approval of tivozanib.
Results from the Phase 1b Portion of DEDUCTIVE Study to Be Presented Friday, January 15, 2021, at ASCO (Free ASCO Whitepaper) GI Cancer Symposium. AVEO is also studying tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with first line metastatic hepatocellular carcinoma in the Phase 1b/2 DEDUCTIVE clinical trial, which is currently in Phase 2, with enrollment expected to complete this year. Results from the Phase 1b portion of the DEDUCTIVE study are expected to be presented at on Friday, January 15, 2021, at 8:00 am ET, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium.
Ficlatuzumab Update
Enrollment Complete in Phase 2 Open Label Randomized Study of Ficlatuzumab in HNSCC; Results Expected to Be Presented at a Medical Meeting in Mid-2021; Phase 3 Decision on Track for Mid-2021. The Company announced today that enrollment is now complete in its randomized confirmatory Phase 2 study of ficlatuzumab as a single agent or in combination with cetuximab, an EGFR-targeted antibody, in metastatic HNSCC patients who have failed prior immunotherapy, chemotherapy and cetuximab (ERBITUX). Ficlatuzumab is AVEO’s potent hepatocyte growth factor (HGF) inhibitor antibody which binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. The study was designed to confirm findings from a Phase 1/2 study of ficlatuzumab and cetuximab where the combination was well tolerated and resulted in a disease control rate of 67%, as well as prolonged progression-free survival (PFS) and overall survival (OS) compared to historical controls.
Results from the Phase 2 study are expected to be presented at a medical meeting in mid-2021. In that timeframe, the Company plans to announce a Phase 3 decision for ficlatuzumab. In September 2020, AVEO regained full global rights to ficlatuzumab and has initiated clinical manufacture of ficlatuzumab to supply a potential Phase 3 clinical trial in HNSCC, as well as additional potential Phase 2 studies in pancreatic cancer and acute myeloid leukemia.
AV-380 Update
Phase 1 Clinical Study Initiated Following U.S. FDA Acceptance of IND Filing. The Company announced today that its investigational New Drug Application (IND) application for AV-380, its first-in-class, potent, humanized inhibitory antibody targeting GDF15, for the treatment of cancer cachexia, has been accepted by the FDA. Cachexia, a common complication in patients with advanced cancer and other chronic diseases, is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions. A Phase 1 study in healthy subjects has been initiated.
About Tivozanib (FOTIVDA)
Tivozanib is an oral, once-daily, next-generation VEGFR TKI discovered by Kyowa Kirin Co. and approved as FOTIVDA for the treatment of adult patients with advanced RCC in the European Union and other countries in the territory of the Company’s partner, EUSA Pharma (UK) Limited (EUSA territory). 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 adult patients with relapsed or refractory advanced 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 RCC.4 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin Co. in non-oncology indications.