AVEO Oncology Highlights Recent Progress and 2021 Outlook
– Commercial Readiness Nearing Completion in Support of Potential Tivozanib
– Updated IP Strategy Offers Potential for Tivozanib Patent Term Extension to
– Phase 2 Open Label Randomized Study of Ficlatuzumab in HNSCC Enrollment Complete; Plans to Announce Results and Phase 3 Decision on Track for Mid-2021 –
– AV-380 Phase 1 Clinical Study Initiated Following FDA’s IND Acceptance –
“We remain keenly focused on building out our commercial team ahead of the potential
Key Recent Program Updates and Anticipated 2021 Milestones
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 today announced 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.
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 2027or November 2028.
Corinne D. Epperly, MD, MPH Appointed to Board of Directors. AVEO today announced the appointment of Corinne D. Epperly, MD, MPH, to its Board of Directors. Dr. Epperlybrings 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 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 Gastrointestinal Cancer Symposium.
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.
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
AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO’s strategy is to focus its resources toward development and commercialization of its product candidates in
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “design,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “could,” “should,” “would,” “seek,” “look forward,” “advance,” “goal,” “strategy,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: AVEO’s planned timing for making tivozanib available to patients in the
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Fotivda (Tivozanib) SmPC
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- Pawlowski N et al. AACR 2013. Poster 3971
- Barthelemy et al. ESMO 2018. Poster 878P
Source: AVEO Oncology