8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 29, 2020

 

 

AVEO Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   001-34655   04-3581650

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

30 Winter Street

Boston, Massachusetts

  02108
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (857) 400-0101

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.001 par value   AVEO   Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 7.01.

Regulation FD.

On May 29, 2020, AVEO Pharmaceuticals, Inc. (the “Company”) will host a conference call to discuss the final overall survival (“OS”) results of its TIVO-3 trial, the Company’s phase 3 trial of tivozanib in advanced renal cell carcinoma. A copy of the Company’s slide presentation accompanying the conference call is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 7.01 and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01

Other Events.

On May 29, 2020, the Company issued a press release announcing the final OS results of its TIVO-3 trial. On May 29, 2020, the Company also issued a press release announcing that the DEDUCTIVE trial, the Company’s phase 1b/2 trial of tivozanib in combination with IMFINZI® (durvalumab) in advanced hepatocellular carcinoma, has progressed to the phase 2 portion of the trial.

The full text of the press releases are attached as Exhibits 99.2 and 99.3 to this Current Report on Form 8-K.

 

Item 9.01.

Financial Statements and Exhibits.

(d)    Exhibits

 

99.1    Corporate slide presentation, dated May 29, 2020
99.2    Press release announcing the final OS results of the TIVO-3 trial, issued by the Company on May 29, 2020
99.3    Press release announcing the phase 2 progression of the DEDUCTIVE trial, issued by the Company on May 29, 2020


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    AVEO Pharmaceuticals, Inc.
Date: May 29, 2020    
    By:  

/s/ Michael Bailey

      Michael Bailey
      President and Chief Executive Officer
EX-99.1

Slide 1

Passionately pursuing a better life for patients with cancer TIVO-3 Overall Survival Update Conference Call May 29, 2020 Exhibit 99.1


Slide 2

Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements 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 facts, contained in this presentation are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate,” “seek,” “look forward,” “advance,” “goal,” “strategy,” “promising,” “opportunity” 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 goals and business strategy, prospects, plans and objectives; AVEO’s plans regarding communications with the U.S. Food and Drug Administration (FDA) for tivozanib; the timing, design and results of preclinical and clinical trials, including AVEO’s plans, and expectations regarding the Phase 3 TIVO-3 study of tivozanib in RCC; the timing and outcome of meetings with and applications to regulatory authorities by AVEO and its partners; the competitive landscape for, and the potential utility of, AVEO’s product candidates, AVEO’s statements regarding the potential efficacy, safety and tolerability profile of tivozanib; the potential commercial opportunity of tivozanib and AVEO’s other product candidates and AVEO’s estimates for its cash runway. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements AVEO makes due to a number of important factors, including substantial risks and uncertainties relating to: AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA and the EMA the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates, including, in particular, tivozanib; AVEO’s and its collaborators’ ability to successfully enroll and complete clinical trials; AVEO’s ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements; the timing and costs of seeking and obtaining regulatory approval; AVEO’s ability to maintain compliance with 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; 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; and those risks discussed in the sections 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 SEC and in other filings that AVEO may make with the SEC in the future. All forward-looking statements contained in this presentation speak only as of the date of this presentation, and AVEO undertakes no obligation, and specifically disclaims any obligation, to update any of these statements, except as required by law.


Slide 3

Introductions Sumanta Kumar (Monty) Pal, M.D. Clinical Professor, Department of Medical Oncology & Therapeutics Research; Co-director, Kidney Cancer Program, City of Hope Cancer Center Michael Bailey, CEO Michael Needle, MD, CMO Erick Lucera, CFO Mike Ferraresso, SVP, Business Analytics and Commercial Operations Agenda TIVO-3 Data Review with Dr. Pal Regulatory Update and Considerations Commercial Opportunity Summary Q&A


Slide 4

TIVO-3: Final OS analysis of a phase 3, randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with metastatic renal cell carcinoma (RCC) May 29, 2020


Slide 5

TIVO-3: Clinical Context The treatment of patients with renal cell carcinoma (RCC) has advanced with the advent of anti-angiogenic drugs known as vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI) Tivozanib is a highly potent and selective VEGFR TKI with a long half-life and an ability to down regulate T-regulatory cells Tivozanib was developed to optimize VEGFR blockade while minimizing off-target toxicities Tivozanib is approved by the European Medicines Agency for the first-line treatment of adult patients with RCC The TIVO-3 study was designed to assess the safety and efficacy of tivozanib versus sorafenib for treatment of patients with highly refractory metastatic RCC In TIVO-3, a significant reduction in the risk of progression-free survival (PFS) was reported for tivozanib compared with sorafenib at a hazard ratio (HR) of 0.73 (95% confidence interval [CI]: 0.56, 0.94; P=0.016); median PFS was 5.6 months vs. 3.9 months Tivozanib demonstrated superior and durable tumor shrinkage as indicated by superior overall response rate (ORR) 18% vs 8% and a longer duration of response (DoR) than sorafenib. Tivozanib treatment demonstrated a favorable tolerability profile as demonstrated by significantly fewer dose reductions, interruptions, and discontinuations due to AEs


Slide 6

TIVO-3: Study Schema N = 350 Recurrent/metastatic RCC ECOG PS 0 or 1 Failed at least two prior regimens including VEGFR-TKI Stratified by IMDC and prior regimen (TKI-TKI; TKI-CPI; TKI-Other) RANDOMIZE 1:1 Endpoints Primary: PFS Secondary: OS, ORR, DoR, Safety and Tolerability for ITT Randomized Trial in Relapsed or Refractory Advanced Renal Cell Carcinoma Tivozanib Sorafenib TKI – VEGFR TKI; CPI – checkpoint inhibitor


Slide 7

TIVO-3: Patient Demographics Characteristic Tivozanib (N=175) Sorafenib (N=175) Median age, years 62 64 Male 72% 73% IMDC prognostic risk Favorable 19% 21% Intermediate 62% 60% Poor 18% 19% ECOG performance status (0/1) (49% / 50%) (47% / 48%) Region (NA/EU) (18% / 82%) (15% / 85%) Prior Lines of Therapy (2/3) (62% / 38%) (59% / 41%) Prior Treatment Regimen TKI-CPI 27% 25% TKI-TKI 45% 46% TKI-Other 28% 29%


Slide 8

TIVO-3: Met Primary Endpoint of PFS Primary PFS endpoint final analyses, Oct 4, 2018 Tivozanib 170 128 94 69 56 48 37 31 24 20 16 14 6 0 0 Sorafenib 159 116 65 42 27 18 11 9 5 3 3 2 2 0 0 1 yr PFS 28% 11% 18% 5% Tivozanib Sorafenib Subjects at risk Tivozanib N=170 Sorafenib N=159 Median, months (95% CI) 5.6 (5.3-7.3) 3.9 (3.9-5.6) HR (95% CI) 0.73 (0.56, 0.94) P-value by stratified log rank 0.0165 2 yr PFS


Slide 9

TIVO-3: Secondary Endpoint, ORR & DoR Statistically Significant Improvement vs Sorafenib Tivozanib Sorafenib ORR 18% 8% ORR p-value 0.02 Median DoR Not reached (12.9, NR) 5.7 months (5.6, NR) % Change in Target Lesion Longest Diameter Sum Response rate final analyses, Oct 4, 2018


Slide 10

TIVO-3: Demonstrated Superior PFS & ORR in CPI Subgroup Prior Checkpoint Inhibitor (CPI) + VEGFR TKI Tivozanib (n=47) Sorafenib (n=44) Sorafenib (n=44) Median PFS months (95% CI) 7.3 (4.8, 11.1) 5.1 (3.2, 7.4) 5.1 (3.2, 7.4) HR (95% CI) 0.55 (0.32, 0.94) P-value 0.028 ORR 24.4% 6.8% Porta et al. ASCO 2019 Tivozanib Sorafenib Final analyses, Oct 4, 2018


Slide 11

TIVO-3: Treatment-Related Adverse Events TRAEs ≥ 20% frequency in either arm* Tivozanib (N=173)^ Sorafenib (N=170)^ Preferred Term All Grades % Grade 3/4 % All Grades % Grade 3/4 % Treatment Related AEs 84 46 94 55 Hypertension 38 21 25 14 Diarrhea 33 2 50 9 Fatigue 29 4 19 5 Decreased Appetite 27 4 21 2 Dysphonia 24 1 8 0 Asthenia 22 5 17 4 PPE/HFSR** 16 1 39 10 Rash 5 0 24 8 >10% difference between arms *Analysis as of Aug 15, 2019 **Palmar-plantar erythrodysesthesia (PPE), also known as hand-foot skin reaction (HFSR) ^Safety population


Slide 12

TIVO-3: Dose Modifications Characteristic Tivozanib (N=173)^ Sorafenib (N=170)^ Mean Number of Cycles Initiated 11.9 6.7 AEs Leading to Dose Reductions (%) 25 39 AEs Leading to Dose Interruption (%) 50 64 ADRs Leading to Permanent Discontinuation (%) 8 15 Treatment Related SAEs (%) 12 11 Treatment Related Deaths (%) 0 0 Deaths within 30 days of Tx (N) 15 13 Exposure Adj Deaths per Month of Tx 0.72% 1.11% P=0.0147 P=0.0164 ^Safety population


Slide 13

Final Overall Survival – May 2020 Tivozanib N=175 Sorafenib N=175 Median OS, months 16.4 19.2 HR (95% CI) 0.97 (0.75–1.25) p-value Stratified Log-rank 0.82 Tivozanib Sorafenib


Slide 14

Conclusions In this final analysis of survival in the TIVO-3 trial, tivozanib demonstrated clinically meaningful and statistically significant improvement in PFS with similar OS in patients with highly relapsed or refractory metastatic RCC Patients treated with a prior CPI and VEGFR TKI or 2 VEGFR TKIs derived the most PFS benefit from tivozanib (HR of 0.55 and 0.57, respectively) relative to sorafenib To our knowledge, TIVO-3 is the first randomized phase 3 study to show PFS superiority over another VEGFR TKI in the third- and fourth-line treatment setting, and is the first study to prospectively and comparatively evaluate treatment following CPI Consistent with other large studies in RCC comparing VEGFR TKIs, the OS HRs did not show significant OS differences between agents Collectively, these data support tivozanib as an evidence-based treatment option for patients with RCC, including for patients whose disease has progressed after previous CPI treatment


Slide 15

Regulatory Update & Considerations


Slide 16

Tivozanib New Drug Application FDA dialogue actively proceeding NDA filed for R/R RCC March 31, 2020 Final OS data submitted as last component of the NDA Application Orientation Meeting (AOM) completed NDA submission is based on the TIVO-3 trial and supported by three additional trials Active comparator-controlled Phase 3 first line study, TIVO-1, comparing tivozanib to sorafenib Phase 2 open-label crossover study, Study 902, of tivozanib for patients who progressed on sorafenib in TIVO-1 Phase 2 placebo-controlled study, Study 201, in first line RCC patients Target indication is relapsed or refractory renal cell carcinoma


Slide 17

Positive Risk/Benefit Profile for Relapsed or Refractory RCC Limited evidence for sequencing therapies in highly refractory RCC or after treatment with a checkpoint inhibitor TIVO-3 provides first Phase 3 dataset in a 3rd and 4th line patient population First large randomized study to evaluate treatment following a checkpoint inhibitor Superior disease control (PFS, ORR & DoR) vs. VEGFR TKI comparator in two large Phase 3 studies Efficacy demonstrated in large single arm study in VEGFR TKI refractory RCC population Safety and OS profile consistent with the VEGFR TKI class RCC monotherapy clinical trial safety data >1,000 patients TIVO-3 confirms no adverse effect on overall survival Years of EU post-marketing treatment experience Superior tolerability compared to sorafenib Fewer dose reductions, interruptions and discontinuations due to AEs


Slide 18

No VEGFR TKI Has Shown an OS Advantage Over Another in RCC Note: Data from separate studies 1) Hutson et al. Clinical Genitourinary Cancer; Vol. 15, No. 1, 72-6. 2) Choueiri et al. European Journal of Cancer 2018; 94: 115e125 3) Motzer et. al. Lancet Oncol 2013; 14: 552–62. 4) Motzer, et al. N Engl J Med. 2014;370(18):1769-1770. Axitinib vs Sorafenib 1st line1 Axitinib vs Sorafenib 2nd Line3 Median OS, months (95% CI) Pazopanib 28.3 months (95% CI 26.0–35.5) Sunitinib 29.1 months (25.4–33.1) HR 0·92, (95% CI 0.79–1.06); stratified log-rank p=0.24 Pazopanib vs Sunitinib 1st line4 Cabozantinib vs Sunitinib 1st line2 All Randomized Patients In All Patients Time (Months)


Slide 19

Commercial Opportunity


Slide 20

If Approved, Significant Potential Commercial Opportunity for Tivozanib in the United States 2nd Line Market (est. 2020) ~$700M1 NA royalties to KHK are low- to mid-teens on net sales Extended OS from IO may expand population eligible for 3rd line treatment 2 1 >PFS with tivozanib may extend treatment duration 65%1 50%1 Efficacy + tolerability may increase patients opting for 3rd and 4th line treatment 1st Line 2nd Line 3rd Line 3 4th Line 25%1 3rd Line+ Market (est. 2020) ~$300M1 Expect opportunity to expand Potential to be first agent indicated for 3rd & 4th line Only pivotal dataset in RCC stratified by prior PD-1 1 Decision Resources Pharmacor 2020 Market Projections July 2019


Slide 21

Potential Relevance of Tivozanib in Refractory RCC Source: AVEO blinded Third-Party U.S. Oncologist Market Research using approximate TIVO-3 PFS and AE profile - Dec 2018 n=100 Treatments with proven efficacy are needed for patients who have failed 2 or more lines of treatment for RCC I prefer using drugs that do not often require me to adjust or interrupt dose due to patient tolerability issues Blinded Tivo Profile Ratings compared to current treatment options in refractory patients Likelihood to Prescribe 67% 80% Not at all likely Neutral Extremely Likely


Slide 22

Nakamura K et al. Cancer Res 2006;66:9134–9142. Pawlowski N et al. AACR 2013. Poster 3971. Hammers, Emerging VEGF-I/O Combinations, ASCO 2017 Tivozanib Properties May Provide Advantages in Combination with IO Therapy A Phase 1/2, Open-Label, Multi-Center Study of Tivozanib in Combination with Nivolumab (OPDIVO®) in Subjects with Advanced Renal Cell Carcinoma A Phase 1/2, Open-Label, Multi-Center Study of Tivozanib in Combination with Durvalumab (IMFINZI®) in Subjects with Hepatocellular Carcinoma Who Have Not Received Prior Systemic Therapy Phase 2 Initiated


Slide 23

Summary FDA dialogue actively proceeding NDA filed for R/R RCC March 31, 2020 Application Orientation Meeting (AOM) completed Tivozanib is well positioned for the changing R/R RCC landscape R/R RCC is a significant monotherapy market opportunity: $1b and growing TIVO-3 is the first positive Phase 3 in 3/4th line and first Phase 3 data to inform sequencing after immunotherapy Foundation for commercial readiness in place Expanding into IO combination TiNivo RCC Phase 2 combination with nivolumab (presented ESMO 2019) DEDUCTIVE HCC Phase 1/2 combination with durvalumab now in Phase 2 Potential partnership & pipeline catalysts on the horizon EUSA (ex-NA oncology partner) TIVO-3 data buy-in of $20M, European and non-European approvals of $6M KKC (tivozanib non-oncology partner) regulatory and development milestones Ficlatuzumab (HGF mAb) and AV-203 (ERBB3 mAb) clinical milestones in 2021, AV-380 (Anti-GDF15 mAb) IND in 2020


Slide 24

Q&A


Slide 25

Passionately pursuing a better life for patients with cancer TIVO-3 Overall Survival Update Conference Call May 29, 2020

EX-99.2

Exhibit 99.2

LOGO

AVEO Oncology Announces TIVO-3 Final Overall Survival Results Featured at ASCO

2020 Virtual Scientific Program and Submitted to U.S. FDA as Part of NDA Filing

- Final OS Hazard Ratio Improves to 0.97 -

- Company to Host Conference Call Today at 8:30 am Eastern Time -

BOSTON, Mass. – May 29, 2020 – AVEO Oncology (NASDAQ: AVEO) today announced the presentation of results from the final analysis of overall survival (OS) in its pivotal Phase 3 TIVO-3 trial comparing tivozanib, the Company’s next-generation vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI), to sorafenib in 3rd and 4th line renal cell carcinoma (RCC). The results, which have been submitted to the U.S. Food and Drug Administration (FDA) as part of the Company’s New Drug Application (NDA) submitted in March, are being featured today at the ASCO 2020 Virtual Scientific Program in a poster 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). A copy of the poster will be available at the ASCO virtual meeting beginning today, May 29, 2020, at 8:00 AM ET. The poster and accompanying oral presentation by Sumanta (Monty) Pal, MD, Associate Clinical Professor, Department of Medical Oncology and Therapeutics Research, and Co-director, Kidney Cancer Program, at City of Hope Comprehensive Cancer Center, can be viewed at www.aveooncology.com.

As previously announced, the TIVO-3 trial met the primary endpoint of progression free survival (PFS) (HR=0.73; p=0.02) and the secondary endpoint of overall response rate (ORR) (18% vs. 8%; p=0.02). The final OS hazard ratio (HR), which assesses the overall relative risk of death, was 0.97 (95% CI: 0.75-1.25; p=0.82), favoring tivozanib and improving from the previously reported interim HR of 0.99. Updated median OS, representing a single point in time in the OS curve, was 16.4 months for tivozanib (95% CI: 13.4-22.2) and 19.2 months for sorafenib (95% CI: 15.0-24.2). These OS HR results are similar to those of prior VEGFR TKI vs. VEGFR TKI studies in RCC.1-4

Tivozanib was found to be generally well-tolerated, with grade 3 or higher adverse events (AEs) consistent with those observed in previous tivozanib trials. The most common AE in patients receiving tivozanib was hypertension (38% vs. 25% for sorafenib, of treated patients), an AE known to reflect effective VEGF pathway inhibition. Infrequent but severe AEs reported in greater number in the tivozanib arm were thrombotic events (5% vs. 4% for sorafenib, of treated patients) similar to those observed in previous tivozanib studies. Dose reductions and interruptions due to AEs were significantly lower for tivozanib vs. sorafenib, despite nearly double the average number of cycles initiated for the tivozanib arm (11.9 months vs. 6.7 months for sorafenib), treatment related AEs leading to permanent discontinuation were 8% for tivozanib vs. 15% for sorafenib.


“We believe the TIVO-3 data demonstrate a favorable risk/benefit profile for tivozanib in the growing population of patients who have relapsed or become refractory to multiple lines of therapy, including checkpoint inhibitors,” said Dr. Pal. “The lack of clinical data to guide treatment decisions in a robust, evidence-based manner in this setting is a serious and growing unmet medical need, particularly as this population continues to grow thanks to improved treatment in earlier lines. TIVO-3 provides the first positive superiority study to help guide this important treatment decision and, furthermore, offers this highly refractory patient population a favorable tolerability profile as indicated by fewer dose reductions, interruptions and discontinuations over a less selective VEGFR TKI in sorafenib.”

“This outcome marks a significant milestone in a long journey to see tivozanib fulfill its potential, and is a critical step forward in our goal to improve both efficacy outcomes and patient experience for individuals living with cancer,” said Michael Bailey, president and chief executive officer of AVEO. “Tivozanib has the potential to define highly refractory kidney cancer treatment, an area with no current evidence-based standard of care. We look forward to continuing our dialogue with the FDA as we work toward a marketing authorization decision, and we will continue to build on our foundation for commercial readiness. We owe our deepest gratitude to the patients and their families for participating in the tivozanib clinical program, and to the healthcare professionals who have continued to believe in the potential of tivozanib.”

Conference Call and Webcast

In connection with this announcement, AVEO will host a conference call and audio webcast today, May 29, 2020, at 8:30 am Eastern Time. Dr. Pal will join the AVEO management team to review the data announced today. The call can be accessed by dialing (844) 882-7841 (U.S. and Canada) or (574) 990-9828 (international). The passcode for the conference call is 7967605. To access the live audio webcast, or the subsequent archived recording, please visit the Investors section of the AVEO website at www.aveooncology.com. The webcast will be recorded and available for replay on AVEO’s website for two weeks.

About Tivozanib (FOTIVDA®)

Tivozanib (FOTIVDA®) is an oral, once-daily, next-generation 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.5,6 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 models7 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC8. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.


About AVEO

AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. AVEO’s strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO’s lead candidate, tivozanib (FOTIVDA®), is approved in the European Union, the United Kingdom, Norway, New Zealand and Iceland for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma, hepatocellular carcinoma and other cancers. Ficlatuzumab (HGF MAb) is in a Phase 2 clinical trial in head and neck cancer and has reported early clinical data in pancreatic cancer. AVEO’s earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb). For more information, please visit the Company’s website at www.aveooncology.com.

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,” “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: the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or advanced RCC, and following earlier TKI and immunotherapy treatment;; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; AVEO’s execution of its clinical and regulatory strategy for tivozanib; AVEO’s plans and strategies for commercialization of tivozanib in the United States and Europe; and AVEO’s strategy, prospects, plans and objectives for its product candidates and for the Company generally. 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:; whether the results of TIVO-3 are sufficient to obtain marketing approval for tivozanib in the U.S., which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA the safety and efficacy of tivozanib based upon the findings of TIVO-3, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may determine to be relevant to approvability; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; and AVEO’s ability to enter into and maintain its third party collaboration and license


agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements. AVEO faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining regulatory approval; AVEO’s and its collaborators’ ability to successfully enroll and complete clinical trials; AVEO’s ability to maintain compliance with 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; AVEO’s ability to successfully implement its strategic plans, including its ability to successfully launch and commercialize tivozanib if it may be approved for commercialization by the FDA; 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; the potential adverse effects of the COVID-19 pandemic on AVEO’s business continuity, financial condition, results of operations, liquidity and ability to successfully and timely enroll, complete and read-out data from its clinical trials; competitive factors; and those risks discussed in the sections 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 makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release, and 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.

Any reference to AVEO’s website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

References

 

1.

Hutson et al. Clinical Genitourinary Cancer; Vol. 15, No. 1, 72-6.

2.

Choueiri et al. European Journal of Cancer 2018; 94: 115e125

3.

Motzer et. al. Lancet Oncol 2013; 14: 552–62.

4.

Motzer, et al. N Engl J Med. 2014;370(18):1769-1770.

5.

Fotivda (Tivozanib) SmPC August 2017

6.

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

7.

Pawlowski N et al. AACR 2013. Poster 3971

8.

Barthelemy et al. ESMO 2018. Poster 878P

AVEO Contact:

David Pitts, Argot Partners

(212) 600-1902    

aveo@argotpartners.com

EX-99.3

Exhibit 99.3

LOGO

AVEO Oncology Announces Phase 1b/2 DEDUCTIVE Study of FOTIVDA® (tivozanib) in

Combination with IMFINZI® (durvalumab) in Previously Untreated Metastatic

Hepatocellular Carcinoma Advances to Phase 2

BOSTON, Mass. – May 29, 2020 – AVEO Oncology (NASDAQ: AVEO) today announced that the Phase 1b/2 DEDUCTIVE clinical trial evaluating FOTIVDA® (tivozanib), the Company’s once-daily, potent and selective next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), in combination with IMFINZI® (durvalumab), AstraZeneca’s (LSE/STO/NYSE: AZN) human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with hepatocellular carcinoma (HCC) who have not received prior systemic therapy, has demonstrated that the combination can be administered safely and the study has successfully progressed to the Phase 2 portion of the trial.

Advancement of the study into the Phase 2 expansion follows the successful completion of the Phase 1 dose escalation portion of the trial, where 1.0 mg of tivozanib was administered for 21 days followed by 7 days rest together with 1500 mg of durvalumab every 28 days (n=6). The combination was well tolerated, with no dose limiting toxicities. The tivozanib regimen of 1.0 mg daily for 21 days, followed by 7 days off treatment, is the recommended Phase 2 dose (RP2D) for the expansion portion of the trial, which is expected to enroll up to an additional 30 subjects. Results from the study were not available ahead of the abstract deadline for the ASCO20 Virtual Scientific Program (abstract# e16599) and will be submitted for presentation at an upcoming scientific meeting.

“With our NDA for single agent tivozanib in relapsed or refractory renal cell carcinoma submitted to the FDA, our clinical focus is on VEGF TKI-immunotherapy combination studies in indications where such combinations show promise, including HCC,” said Michael Bailey, president and chief executive officer. “We believe the safety we have seen in Phase 1 of this combination study supports the unique profile that would make tivozanib an attractive VEGF TKI to combine with immunotherapy. Combinations such as those explored in the TiNivo and DEDUCTIVE trials could represent the future of treatment in kidney and liver cancer, respectively, and our goal is to establish tivozanib as a TKI companion of choice.”

The trial is being conducted as part of a clinical collaboration between AVEO and AstraZeneca. AVEO is serving as the study sponsor.

About Tivozanib (FOTIVDA®)

Tivozanib (FOTIVDA®) is an oral, once-daily, next-generation 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/ 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 AVEO

AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. AVEO’s strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO’s lead candidate, tivozanib (FOTIVDA®) is approved in the European Union, the United Kingdom, Norway, New Zealand and Iceland for the treatment of adult patients with advanced renal cell carcinoma. AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma, hepatocellular carcinoma and other cancers. Ficlatuzumab (HGF MAb) is in a Phase 2 clinical trial in head and neck cancer and has reported early clinical data in pancreatic cancer. AVEO’s earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb). For more information, please visit the Company’s website at www.aveooncology.com.

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,” “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: the potential for tivozanib as a treatment option for patients with advanced HCC or relapsed/refractory or advanced RCC, and following earlier TKI and immunotherapy treatment; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; AVEO’s execution of its clinical and regulatory strategy for tivozanib; AVEO’s plans and strategies for commercialization of tivozanib in the United States and Europe; and AVEO’s strategy, prospects, plans and objectives for its product candidates and for the Company generally. 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: whether the results of TIVO-3 are sufficient to obtain marketing approval for tivozanib in the U.S., which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA the safety and efficacy of tivozanib based upon the findings of TIVO-3, including its data with respect to PFS, the rate of adverse events, OS and other information that the FDA may determine to be relevant to approvability; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; and AVEO’s ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements. AVEO faces other risks relating to its business as well, including risks relating to the timing and costs of seeking and obtaining regulatory approval; AVEO’s and its collaborators’ ability to successfully enroll and complete clinical trials; AVEO’s ability to maintain compliance with 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; AVEO’s ability to successfully implement its strategic plans, including its ability to successfully launch and commercialize tivozanib if it may be approved for commercialization by the FDA; 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; the potential adverse effects of the COVID-19 pandemic on AVEO’s business continuity, financial condition, results of operations, liquidity and ability to successfully and timely enroll, complete and read-out data from its clinical trials; competitive factors; and those risks discussed in the sections 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 makes with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release, and 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. Any reference to AVEO’s website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

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.

4.

Barthelemy et al. ESMO 2018. Poster 878P

AVEO Contact:

David Pitts, Argot Partners

(212) 600-1902    

aveo@argotpartners.com