– Commercial Readiness Nearing Completion in
Support of Potential Tivozanib U.S. Launch –
– Updated IP Strategy Offers Potential for
Tivozanib Patent Term Extension to November 2028 –
– Corinne D. Epperly, MD, MPH, Appointed to
Board of Directors –
– 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 –
AVEO Oncology (Nasdaq: AVEO) today highlighted its recent
progress and outlined its 2021 outlook.
“We remain keenly focused on building out our commercial team
ahead of the potential U.S. launch of tivozanib as a treatment for
relapsed or refractory renal cell carcinoma (RCC), including the
addition of Dr. Corinne Epperly to our Board of Directors,” said
Michael Bailey, president and chief executive officer of AVEO. “If
approved, we believe tivozanib has the potential to serve as a new
treatment for the rapidly growing population of patients with
relapsed or refractory RCC. In support of the further clinical and
commercial development of tivozanib, we have identified
opportunities to potentially extend its patent exclusivity
period.”
Mr. Bailey added: “In addition to our launch preparation, we
continue to make great progress advancing our clinical pipeline,
with each asset expected to reach an important milestone this year.
These include progress in our immunotherapy combination programs
for tivozanib, a decision on whether to initiate a pivotal study of
ficlatuzumab in head and neck squamous cell carcinoma (HNSCC), and
the execution of our Phase 1 study of AV-380. We believe 2021 will
be a transformational year for AVEO, and we look forward to
delivering on a number of milestones designed to enhance our
long-term value.”
Key Recent Program Updates and
Anticipated 2021 Milestones
Tivozanib U.S. Regulatory and Commercial Updates
- 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.
Corporate Updates
- 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 2027 or 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. Epperly brings
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.
Ficlatuzumab Update
- 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.
AV-380 Update
- 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 European Union
and other countries in the territory of the Company’s partner, EUSA
Pharma (UK) Limited (EUSA territory). 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 adult
patients with relapsed or refractory advanced 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 Co. in non-oncology
indications.
About AVEO Pharmaceuticals, Inc.
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
North America, while leveraging partnerships to support development
and commercialization in other geographies. AVEO’s lead candidate,
tivozanib, is approved as FOTIVDA® in the European Union and other
countries in the EUSA territory for the treatment of adult patients
with advanced RCC. 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. 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,” “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 U.S.; the
potential for tivozanib as a treatment option for patients with
advanced HCC or relapsed/refractory or advanced RCC; 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;
the advancement of AVEO’s pipeline, including the advancement of
ficlatuzumab in multiple clinical studies; the potential efficacy,
safety and tolerability of ficlatuzumab, both as a stand-alone drug
candidate and in combination with other therapies; the potential
outcomes from studies of ficlatuzumab to provide AVEO with
opportunities to pursue regulatory strategies; the potential
clinical utility of ficlatuzumab in areas of unmet need; the
potential to extend U.S. patent exclusivity for tivozanib and the
timing of such potential extension; 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 consider to be relevant to an approval determination;
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
and to obtain and maintain market and third party payor acceptance
of 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 launch and commercialization of tivozanib; 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
risks relating to the timing and costs of seeking and obtaining
regulatory approvals; 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’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; unplanned capital requirements; uncertainties related
to AVEO’s ability to access future borrowings under the Hercules
loan facility, which turns on the achievement of milestones related
to the approval and commercialization of tivozanib in the U.S.,
which milestones may not be achieved; 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 “Cautionary Note
Regarding Forward-Looking Statements” in AVEO’s September 2020
press release regarding ficlatuzumab, and 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
- 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/20210107005248/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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