Press Release

AVEO Oncology and EUSA Pharma Announce Updated Interim Results from Phase 2 Portion of the TiNivo Study in Renal Cell Carcinoma

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Tivozanib-Nivolumab Combination Continues to Demonstrate Favorable Efficacy and Safety

Data Presented at the European Society of Medical Oncology (ESMO) 2018 Annual Congress

CAMBRIDGE, Mass. & HEMEL HEMPSTEAD, England–(BUSINESS WIRE)–Oct. 22, 2018– AVEO Oncology (NASDAQ:AVEO) and EUSA Pharma today announced the presentation of updated interim results from the Phase 2 portion of the TiNivo study, a Phase 1b/2 multicenter trial 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 or metastatic renal cell carcinoma. The results were presented today at European Society of Medical Oncology (ESMO) 2018 Annual Congress, in a poster presentation titled “TiNivo: Tivozanib Combined with Nivolumab: Safety and Efficacy in Patients with Metastatic Renal Cell Carcinoma (mRCC)” (Presentation 878P). A copy of the presentation is available at www.aveooncology.com or further information can be obtained via EUSA Pharma Medical Information.

The Phase 1b/2 study has enrolled a total of 28 patients. The Phase 2 portion of the study (n=22) was designed to assess the safety, tolerability, and anti-tumor activity of the full dose and schedule of PO tivozanib (1.5 mg/QD for 21 days followed by a 7-day rest period), as established in the Phase 1b portion of the study (n=6), in combination with IV nivolumab (240 mg every 2 weeks). The combination was generally well tolerated. Treatment-related Grade 3/4 adverse events occurred in 60% of patients, the most common of which was hypertension.

Interim efficacy was assessed in all 25 patients treated with the full dose and schedule of PO tivozanib in combination with IV nivolumab and enrolled at least 4 months prior to the data cutoff date. Of these, 13 (52%) had received at least one prior systemic therapy. An objective response rate was observed in 56% of patients (complete responses + partial responses), including 4% of patients (n=1) achieving a complete response, and a disease control rate (complete response + partial response + stable disease) was observed in 96% of patients. At the time of data collection 52% (n=13), of patients remained on study. To date, a total of 72% of patients (n=18) had tumor shrinkage of ≥25%, with a majority of patients having disease control for ≥48 weeks.

“With high and durable tumor shrinkage rates for the combination of tivozanib and nivolumab, including a complete response, coupled with a favorable tolerability profile and nearly all patients having disease control, the TiNivo study continues to underscore a compelling rationale for using a high-specificity VEGF inhibitor as the TKI of choice in immuno-oncology combinations,” Doctor Bernard Escudier, MD, ex-Chairman of the Genitourinary Oncology Committee, Gustave Roussy, and lead investigator of the study. “The ability to give a VEGF inhibitor and immuno-oncology agent both at full dose and strength could serve to deliver both improved outcomes and an improved patient experience. I look forward to better understanding tivozanib’s potential in immunotherapy combinations through a larger randomized study, which is currently being planned.”

“There are multiple cancers where IO-TKI combinations have demonstrated potential, and the favorable tolerability and efficacy outcomes seen in the TiNivo study make further exploration of these indications a priority for AVEO,” said Michael Bailey, president and chief executive officer of AVEO. “We continue to build out a clinical strategy for studying such combinations, and look forward to outlining our plans following reporting of topline data from our Phase 3 TIVO-3 study, which is expected in the mid-fourth quarter.”

“The data arising from combination studies with checkpoint inhibitors demonstrate the considerable potential for tivozanib in metastatic RCC,” said Lee Morley, Chief Executive Officer of EUSA Pharma. “EUSA continues to launch tivozanib across the EU in line with its EMA approval as monotherapy in the first line setting where its efficacy and favorable tolerability profile continue to provide benefits to patients, and we are excited by the prospect of further development of tivozanib as part of a future IO-TKI treatment option.”

About Tivozanib (FOTIVDA®)

Tivozanib (FOTIVDA®) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway 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 has been shown to significantly reduce regulatory T-cell production in preclinical models, enabling potentially enhanced activity when used in combination with immune modulating therapy.3 As part of a North American registration plan, tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

About AVEO

AVEO Pharmaceuticals, Inc. (the “Company”) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted medicines for oncology and other areas of unmet medical need. The Company’s strategy is to retain North American rights to its oncology portfolio while securing partners in development and commercialization outside of North America. The Company is seeking to develop and commercialize its lead candidate tivozanib in North America as a treatment for advanced or metastatic renal cell carcinoma (“RCC”). The Company has outlicensed tivozanib (FOTIVDA®) for oncology in Europe and other territories outside of North America. Tivozanib is approved in the European Union, as well as Norway and Iceland, for the first-line treatment of adult patients with RCC and for adult patients who are vascular endothelial growth factor receptor and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for RCC. The Company has entered into partnerships for the development and commercialization of AV-203 (CAN017) and ficlatuzumab, both clinical stage assets in oncology. The Company is currently seeking a partner to develop the AV-353 platform, a preclinical asset, worldwide for the potential treatment of pulmonary arterial hypertension. The Company has recently regained the rights to its AV-380 program for the potential treatment of cachexia and is considering a variety of options to advance the program’s development.

For more information, please visit the Company’s website at www.aveooncology.com.

About EUSA Pharma

Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has commercial operations in the United States and Europe, and a wider distribution network in approximately 40 countries around the world. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information, please visit www.eusapharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO 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,” “expect,” “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: the expected benefits of combining TKIs and checkpoint inhibitors; the expected timeline for reporting topline data from TIVO-3; and AVEO’s strategy, prospects, plans and objectives, including as they pertain specifically to tivozanib. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to AVEO’s ability to enter into and maintain its third-party collaboration and license agreements, and its ability, and the ability of its collaborators, licensees and other strategic partners, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its collaborators and licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates, including tivozanib. AVEO faces other risks relating to its business as well, including risks relating to its and its collaborators’ ability to successfully enroll and complete clinical trials, including the TIVO-3 and TiNivo studies; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s shareholder litigation; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s quarterly and annual reports on file with the Securities and Exchange Commission (SEC) and in other filings that AVEO may make with the SEC in the future. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.

References

1. Fotivda (Tivozanib) SmPC August 2017

2. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.

3. Pawlowski N et al. AACR 2013. Poster 3971.

Source: AVEO Oncology

AVEO:
Argot Partners
David Pitts, 212-600-1902
aveo@argotpartners.com
or
EUSA:
EUSA Pharma
Lee Morley, +44 (0)330 5001140
Chief Executive

Noelia Rycerz

Noelia Rycerz brings more than 17 years of global drug development experience to her role at Aveo Oncology. Ms. Rycerz has held roles of increasing seniority in Clinical Operations and Program Management at Amgen Inc., Pfizer Inc., and Odonate Therapeutics, Inc. She led and executed clinical phase 1 – 3 clinical trials in varying therapeutics areas including oncology, rheumatology and cardiovascular disease. During her time at Amgen Inc. as a Program Manager, she supported CMC, Regulatory and Safety Affairs to ensure delivery of marketing applications leading to approval of Corlanor®. While at Pfizer, Ms. Rycerz was accountable for oversight of pivotal clinical trials and support of regulatory inspections leading to marketing application approvals for Xeljanz®, Besponsa® and Daurismo®. Ms. Rycerz received a Bachelors of Science at Boston University. 

Kevin Peacock

Kevin Peacock currently serves as AVEO’s Senior Vice President of Marketing. Prior to joining AVEO, he served as both the Vice President, New Product Planning and Business Development at Lycera where he was leading the early commercialization process for Lycera’s novel immune-oncology compounds and in 2015 completed an exclusive strategic collaboration and license with Celgene resulting in $100M in non-dilutive financing. Mr. Peacock also previously served as Vice President, Global Marketing and Business Analytics at Dendreon, where he led the launch of Provenge® in select European countries and managed the US Business Analytics team. Mr. Peacock was Senior Director and Product Champion for Savient Pharmaceuticals while working on Krystexxa® and previously served as Senior Director of New Product Planning at Allos Therapeutics. Prior to that, Mr. Peacock held various roles on the ERBITUX® brand team while at ImClone Systems. Mr. Peacock’s has extensive experience in the oncology commercialization process including marketing, market research, new product planning and product development on the R&D side. Mr. Peacock earned his Bachelor of Administration in Finance and Risk Management from Temple University.  

Scarlett Spring

Scarlett Spring currently serves as Co-Founder and Chief Executive Officer of TapRoot Interventions & Solutions, a platform technology company focused on providing real-time, tailored interventions to caregivers managing patients with Alzheimer’s and dementia behaviors. She previously served as President and Chief Commercial Officer for VisionGate, Inc., a clinical-stage pharmaceutical and diagnostics company developing products for the early detection, prevention, and treatment of lung cancer. Prior to VisionGate, Ms. Spring served in various sales and commercial roles of increasing responsibility at Merck and AstraZeneca Pharmaceuticals. At AstraZeneca, she was involved in the successful launches of Prilosec®, Nexium®, Crestor® and Iressa®, and managed the hormonal portfolio for AstraZeneca Oncology. Ms. Spring also previously served as Executive Vice President and Chief Operating Officer of the Greater Phoenix Economic Council. She currently serves on the Arizona Bioscience Board and Risk Capital Committee of the Flinn Foundation, as well as on the Boards of Republic Bank of Arizona and the Arizona Sports and Tourism Authority. Ms. Spring  received a Bachelor’s degree in Marketing from the University of Texas at Austin and a Master’s in Business Administration from Pepperdine University.  Ms. Spring has served as a director of AVEO since 2019 and is chairperson of the compensation committee and a member of the audit committee.   

Manoj Patel, PharmD

Manoj Patel has more than 20 years of experience in the pharmaceutical industry, over 15 of which are directly in the development of oncologic treatments and joins AVEO as Vice President of Program Management. Prior to joining AVEO’s management team, Dr. Patel led the development of several biologics programs as a Project Leader within Teva’s specialty pharma group. Prior to Teva, he held several senior level positions within Project and Program Management as well as Customer Solutions at PRA Health Sciences (now part of ICON) and IQVIA. During his tenure at these CROs, Dr. Patel oversaw the development of oncology treatments for several major pharmaceutical and biotech clients. Prior to IQVIA, he worked at GlaxoSmithKline for more than 10 years across multiple functions that included Clinical Development, Medical Affairs and Project Management. Dr. Patel was also Sr. Director of Program and Alliance Management at ImClone Systems and was involved in the process leading to the ultimate sale of the company to Eli Lilly. Dr. Patel received BS degrees in Chemistry and Pharmacy from the University of North Carolina at Chapel Hill and a Doctorate of Pharmacy from Campbell University.

Greg Oehrtman, PhD

Greg Oehrtman brings over 20 years of Drug Development experience to his role returning to AVEO after 8 years.  Dr. Oehrtman has held roles of increasing seniority in Drug Development and Manufacturing at Quintiles/Catalent, Amylin, Stealth Biotherapeutics, and Dicerna.  He has led both drug substance and product development and manufacturing from early pre-clinical to commercial validations, supporting development of Fast Acting Advil, Advil PM, Bydureon, FOTIVDA, Elamipretide, and Nedosiran.  While in these roles, he has managed product development of small molecules, peptides, and antibodies as oral and sterile injectable along with combination device development.  Dr. Oehrtman received his Ph.D in Chemical Engineering from Massachusetts Institute of Technology.

Jason Noto

Jason Noto brings over 20 years of broad commercial leadership experience to his role as Senior Vice President of Market Access at AVEO Oncology. Prior to joining AVEO, Jason served as Vice President at 1798 Consultants, a strategic market access consultancy specializing in integrated channel strategy, patient support services (HUB), payer contract development and assessment, financial impact analysis, and related Access functions. Earlier, Jason served as Senior Director of Market Access Strategy and Payer Marketing at Amag Pharmaceuticals, leading Payer marketing efforts across all business units totaling >$600M in revenue in 2019.

Prior to his tenure at Amag Pharmaceuticals, Mr. Noto held various launch, in-line, and multi-channel marketing leadership roles of increasing responsibility at Sunovion Pharmaceuticals, Alkermes, and Bristol-Myers Squibb Company. During his career, Mr. Noto has had responsibility for the US commercial launch of various specialty products in oncology, immunology, CNS, & ultra-orphan disease states. Mr. Noto received a B.S. in Business Administration from Le Moyne College and an M.B.A. in finance from the Carroll School of Management at Boston College.

Gregory T. Mayes

Mr. Mayes is the President and Chief Executive Officer of Reunion Neuroscience Inc. and has over 20 years of pharmaceutical drug development experience. Before Reunion, he served as President, Chief Executive Officer and director of Antios Therapeutics. Prior to his service at Antios, Mr. Mayes raised $40 million from prominent investors and founded the clinical-stage pharmaceutical company, Engage Therapeutics, to develop a product candidate for seizures. Engage was sold to UCB in 2020 in a deal valued at $270 million following the successful completion of its randomized, phase 2b clinical study. Prior to Engage, Mr. Mayes played an integral role in the growth of Advaxis Immunotherapies (NASDAQ: ADXS), a biotech company developing immuno-oncology therapies for patients with hard-to-treat cancers through its bacterial vector system, Lm Technology™. As its Chief Operating Officer, he was instrumental in helping to secure in excess of $200 million in follow-on funding and developing partnerships with companies such as Amgen, AstraZeneca and Merck & Co. From 2004 to 2010, Mr. Mayes served as Vice President, General Counsel and Chief Compliance Officer at ImClone Systems Corporation. During his tenure at ImClone, Mr. Mayes supported the clinical development and commercialization of ERBITUX® and contributed significantly to activities that resulted in its acquisition by Eli Lilly for $6.5 billion in 2008. Mr. Mayes is a cum laude graduate of Syracuse University, where he was recognized as a Remembrance Scholar and he earned his J.D. degree magna cum laude from the Temple University School of Law, where he was the Articles Editor on the Temple Law Review. Mr. Mayes has served as a director of AVEO since 2019 and is a member of the compensation and nominating and governance committees. 

Click Here To View Our ASCO Poster:

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)