AVEO Oncology Announces $2.8M Development Milestone Earned from Kyowa Kirin
August 05 2020 - 4:05PM
Business Wire
AVEO Oncology (Nasdaq: AVEO) today announced that it has earned
a $2.8 million development milestone payment from partner Kyowa
Kirin Co., Ltd. (Kyowa Kirin). The milestone relates to acceptance
by the Japanese Pharmaceuticals and Medical Devices Agency of an
investigational new drug (IND) application for tivozanib in a
non-oncology indication being developed by Kyowa Kirin.
“This milestone marks an important step forward for AVEO’s
non-oncology pipeline,” said Michael Bailey, president and chief
executive officer of AVEO. “We believe tivozanib’s potential in
non-oncology indications is significant, and we look forward to
seeing Kyowa Kirin move this formulation into the clinic.”
Under the terms of AVEO’s agreement with Kyowa Kirin, in
addition to the previously-paid upfront payment of $25 million to
AVEO and waiver of AVEO’s obligation to make an $18 million
milestone payment upon AVEO gaining U.S. marketing approval of
tivozanib for renal cell carcinoma, and now the IND development
milestone, Kyowa Kirin has also agreed to pay AVEO up to an
additional $388 million in potential milestone payments upon the
successful achievement of certain development, regulatory, and
commercial objectives in non-oncology indications of tivozanib.
Kyowa Kirin will also be obligated to make tiered royalty payments
on the net sales of a product for these indications, ranging from a
high single-digit to low double-digit percent.
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 activity and minimal dose modifications.1,2
AVEO’s TIVO-3 trial is supporting a regulatory submission in the
U.S. seeking marketing approval of tivozanib 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 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 in non-oncology
indications.
About AVEO Pharmaceuticals, Inc.
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 and
hepatocellular carcinoma. AVEO has previously reported promising
early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck
cancer, acute myeloid leukemia and pancreatic cancer and is
conducting a randomized Phase 2 confirmatory clinical trial of
ficlatuzumab in head and neck cancer. AVEO’s earlier-stage pipeline
includes several monoclonal antibodies in oncology development,
including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and
AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an
environment of diversity and inclusion as a foundation for
innovation.
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: tivozanib’s potential in
non-oncology indications; the potential of AVEO to receive future
milestone and royalty payments under its agreement with Kyowa
Kirin; the potential for tivozanib as a treatment option for
patients with advanced HCC or relapsed/refractory or advanced RCC,
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
current and future clinical trials of tivozanib, ficlatuzumab and
AV-380 and for commercialization of tivozanib in the United States;
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 for approval;
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.
References
- Fotivda (Tivozanib) SmPC August 2017
- Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30):
3791-9
- Pawlowski N et al. AACR 2013. Poster 3971
- Barthelemy et al. ESMO 2018. Poster 878P
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200805005998/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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