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): June 1, 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) |
Registrants 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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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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 |
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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 8.01 |
Other Events. |
On June 1, 2020, AVEO Pharmaceuticals, Inc. (the Company) issued a press release announcing that the U.S. Food and Drug Administration (the FDA) accepted for filing the Companys New Drug Application (the NDA), which seeks approval for tivozanib as a treatment for relapsed or refractory renal cell carcinoma. The FDA assigned the NDA standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee to discuss the NDA.
The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
99.1 | Press release issued by the Company on June 1, 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: June 1, 2020 | By: | /s/ Michael Bailey | ||||
Michael Bailey | ||||||
President and Chief Executive Officer |
Exhibit 99.1
AVEO Oncology Announces FDA Acceptance for Filing of a New Drug Application for
Tivozanib as a Treatment of Relapsed or Refractory Renal Cell Carcinoma
- Tivozanib assigned PDUFA target action date of March 31, 2021;
FDA indicates that it does not currently plan to convene an ODAC -
BOSTON, Mass. June 1, 2020 AVEO Oncology (NASDAQ: AVEO) today announced that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib, the Companys next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC). The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.
The acceptance of our NDA filing marks yet another important milestone for AVEO, as we pursue our goal of providing RCC patients whose disease has relapsed or become refractory to multiple lines of therapy with a meaningful new treatment option, said Michael Bailey, president and chief executive officer. We look forward to working closely with the FDA over the coming months during their review of our application. In parallel, we continue to focus on commercial-readiness to ensure we are well positioned to support the potential launch of tivozanib, subject to approval.
The NDA submission is based on AVEOs pivotal Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC, including results recently presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program. The application is also supported by three additional trials, including an active comparator-controlled Phase 3 study, TIVO-1, comparing tivozanib to sorafenib in first line RCC, and two Phase 2 studies, Study 902, the open-label, crossover clinical study of tivozanib for patients who progressed on sorafenib in TIVO-1, as well as placebo-controlled Study 201 in first line RCC. In total, data from over 1,000 clinical trial subjects support the application.
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 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 AVEO
AVEO is developing an oncology pipeline designed to provide a better life for patients with cancer. AVEOs 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. AVEOs 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. AVEOs 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 Companys 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; AVEOs execution of its clinical and regulatory strategy for tivozanib; AVEOs plans and strategies for commercialization of tivozanib in the United States and Europe; and AVEOs 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; AVEOs 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 AVEOs product candidates; and AVEOs 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; AVEOs and its collaborators ability to successfully enroll and complete clinical trials; AVEOs ability to maintain compliance with regulatory requirements applicable to its product candidates; AVEOs ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates; AVEOs 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; AVEOs 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 AVEOs 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 Managements Discussion and Analysis of Financial Condition and Results of OperationsLiquidity and Capital Resources included in AVEOs 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 AVEOs 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 AVEOs views as of any date other than the date of this press release.
Any reference to AVEOs 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