Aravive Announces Phase 3 Trial Design for AVB-500 in Platinum Resistant Ovarian Cancer
November 19 2020 - 7:00AM
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology
company developing transformative therapeutics, today
announced the Company has received guidance from the U.S. Food and
Drug Administration (FDA) on a Phase 3 trial design for AVB-500 in
platinum resistant ovarian cancer (PROC). The global, randomized,
double-blind, placebo-controlled adaptive trial is designed to
evaluate efficacy and tolerability of AVB-500 at a dose of 15 mg/kg
in combination with paclitaxel.
“We look forward to advancing AVB-500 into a pivotal Phase 3
trial in platinum resistant ovarian cancer, following the promising
results from our Phase 1b trial and productive conversations with
the FDA,” said Gail McIntyre, Ph.D., Chief Executive Officer
of Aravive. “With agreement from the FDA that our preclinical
and clinical pharmacology programs are now complete, we anticipate
that this trial, if successful, could support the submission of a
biologics license application to the FDA. We plan to initiate the
trial in the first quarter of 2021, with an interim analysis
expected a year later.”
The pivotal, adaptive Phase 3 trial is expected to enroll
approximately 300-400 patients with high-grade serous ovarian
cancer who have received one to four prior lines of therapy. This
global trial is planned to be conducted at approximately 100 sites
in the U.S. and Europe. The primary endpoint for the trial is
progression free survival, and secondary endpoints include overall
survival, objective response rate, duration of response, quality of
life, clinical benefit rate, and pharmacokinetic and
pharmacodynamic profile. Prospectively defined interim analyses
will investigate treatment differences in patients who have
previously received bevacizumab versus those who have not and will
explore the biomarkers identified in the Phase 1b trial in an
effort to test the hypotheses generated from the Phase 1b data.
Based on the interim analyses, the trial can be adapted to include
only those patients who have not previously been treated with
bevacizumab and/or whose baseline serum biomarker results meet the
identified threshold.
About AVB-500AVB-500 is a therapeutic
recombinant fusion protein that has been shown to neutralize GAS6
activity by binding to GAS6 with very high affinity in preclinical
models. In doing so, AVB-500 selectively inhibits the GAS6-AXL
signaling pathway, which is upregulated in multiple cancer types
including ovarian cancer. In preclinical studies, GAS6-AXL
inhibition has shown anti-tumor activity in combination with a
variety of anticancer therapies, including radiation therapy,
immuno-oncology agents, and chemotherapeutic drugs that affect DNA
replication and repair. Increased expression of AXL and GAS6 in
tumors has been correlated with poor prognosis and decreased
survival and has been implicated in therapeutic resistance to
conventional chemotherapeutics and targeted therapies. AVB-500 is
currently being evaluated in clinical trials and has been granted
Fast Track Designation by the U.S. Food and Drug Administration in
platinum resistant recurrent ovarian cancer. Analysis of all safety
data to date showed that AVB-500 has been generally well-tolerated
with no dose-limiting toxicities or unexpected safety signals.
About AraviveAravive, Inc. is a
clinical-stage oncology company developing transformative
therapeutics designed to halt the progression of life-threatening
diseases. Aravive’s lead therapeutic, AVB-500, is an ultra-high
affinity decoy protein that targets the GAS6-AXL signaling pathway
associated with tumor cell growth. Aravive recently successfully
completed a Phase 1b trial of AVB-500 in platinum resistant ovarian
cancer and selected 15 mg/kg as the dose for the Phase 3 trial.
While the Phase 1b trial of AVB-500 in platinum resistant ovarian
cancer was a safety trial and not powered to demonstrate efficacy,
all 5 patients in the 15 mg/kg cohort experienced clinical benefit,
with 1 complete response, 2 partial responses, and 2 stable
disease. The Company also intends to initiate a Phase 1b/Phase 2
trial of AVB-500 in clear cell renal cell carcinoma later this
year. For more information, please visit www.aravive.com.
Forward-Looking StatementsThis communication
contains forward-looking statements (including within the meaning
of Section 21E of the United States Securities Exchange Act of
1934, as amended, and Section 27A of the United States Securities
Act of 1933, as amended), express or implied, such statements
regarding advancing AVB-500 into a pivotal Phase 3 trial during
first quarter 2021, the trial supporting the submission of a
biologics license application to the FDA, conducting an interim
analysis a year later, enrollment of approximately 300-400 patients
with high-grade serous ovarian cancer who have received one to four
prior lines of therapy, the trial being conducted at approximately
100 sites in the U.S. and Europe. Forward-looking statements are
based on current beliefs and assumptions, are not guarantees of
future performance and are subject to risks and uncertainties that
could cause actual results to differ materially from those
contained in any forward-looking statement as a result of various
factors, including, but not limited to, risks and uncertainties
related to: our ability to initiate a pivotal trial during first
quarter 2021, the trial supporting the submission of a biologics
license application to the FDA, our ability to conduct an interim
analysis a year later, as planned, our ability to enroll
approximately 300-400 patients with high-grade serous ovarian
cancer who have received one to four prior lines of therapy as
planned, our ability to conduct the trial at approximately 100
sites in the U.S. and Europe as planned, our ability to initiate a
Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell
carcinoma as planned later this year, the impact of COVID-19 on the
Company's clinical strategy, clinical trials, supply chain and
fundraising, the Company's ability to expand development into
additional oncology indications, the Company's dependence upon
AVB-500, AVB-500's ability to have favorable results in clinical
trials and ISTs, the clinical trials of AVB-500 having results that
are as favorable as those of preclinical and clinical trials, the
ability to receive regulatory approval, potential delays in the
Company's clinical trials due to regulatory requirements or
difficulty identifying qualified investigators or enrolling
patients especially in light of the COVID-19 pandemic; the risk
that AVB-500 may cause serious side effects or have properties that
delay or prevent regulatory approval or limit its commercial
potential; the risk that the Company may encounter difficulties in
manufacturing AVB-500; if AVB-500 is approved, risks associated
with its market acceptance, including pricing and reimbursement;
potential difficulties enforcing the Company's intellectual
property rights; the Company's reliance on its licensor of
intellectual property and financing needs. The foregoing review of
important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including the risk factors included in the Company's
Annual Report on Form 10-K for the fiscal year ended December 31,
2019, recent Current Reports on Form 8-K and subsequent filings
with the SEC. Except as required by applicable law, the Company
undertakes no obligation to revise or update any forward-looking
statement, or to make any other forward-looking statements, whether
as a result of new information, future events or otherwise.
Contacts:Media:Sheryl Seapy,
W2Osseapy@w2ogroup.com(213) 262-9390
Investors:Luke Heagle, W2O lheagle@w2ogroup.com (910)
726-1372
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