Aravive to Present New Preliminary Data from Phase 1b Trial Evaluating AVB-500 in Clear Cell Renal Cell Carcinoma at 2021 Society for Immunotherapy of Cancer Annual Meeting
October 01 2021 - 7:00AM
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing innovative therapeutics to treat life-threatening
diseases, today announced that new preliminary safety,
pharmacokinetic, pharmacodynamic, and clinical activity data from
the Phase 1b portion of its open-label Phase 1b/2 trial evaluating
AVB-500 in combination with cabozantinib in patients with clear
cell renal cell carcinoma (ccRCC) will be presented at the Society
for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting. The
meeting is being held November 10-14, 2021 in Washington, D.C.
Poster Presentation Details:
Title: |
A Phase 1b/2
randomized study of AVB-S6-500 in combination with cabozantinib
versus cabozantinib alone in patients with advanced clear cell
renal cell carcinoma who have received front-line treatment |
Presenter: |
Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of
Aravive |
Date: |
November 13, 2021 |
Time: |
7:00 AM – 8:30 PM ET |
Location: |
Hall E |
For additional information, please visit the SITC
36th Annual Meeting website:
https://www.sitcancer.org/2021/home.
About the AVB-500 Phase 1b/2 ccRCC TrialAravive
initiated the Phase 1b portion of the Phase 1b/2 trial of AVB-500
in ccRCC in March 2021. The Phase 1b portion of the clinical trial,
a dose escalation study, is expected to enroll approximately 18
patients in three dosing arms (15 mg/kg, 20 mg/kg and 25 mg/kg) to
evaluate tolerability, pharmacokinetics, pharmacodynamics, and
clinical activity of AVB-500 in combination with cabozantinib. The
controlled, randomized, open-label Phase 2 portion of the clinical
trial is expected to enroll approximately 45 patients and
investigate the recommended AVB-500 dose identified during the
Phase 1b portion of the clinical trial in combination with
cabozantinib versus cabozantinib alone. The primary endpoint is
progression-free survival. The trial is enrolling patients with
advanced ccRCC who have progressed on front-line treatment. The
Phase 1b/2 trial is listed on clinicaltrials.gov NCT04300140.
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, renal and pancreatic 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 multiple
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 innovative therapeutics
to treat life-threatening diseases. Aravive’s lead therapeutic,
AVB-500, is a first-in-class ultra-high affinity decoy protein that
targets the GAS6-AXL signaling pathway associated with tumor cell
growth, tumor metastasis, resistance to treatment and decreased
survival. AVB-500 has the potential to be combined with multiple
anticancer therapies across several tumor types, due to its novel
mechanism of action and favorable safety profile. The Company is
currently evaluating AVB-500 in a registrational Phase 3 trial in
platinum resistant ovarian cancer, a Phase 1b/2 trial in second
line plus, clear cell renal cell carcinoma, and a Phase 1b/2 trial
in first-line treatment of pancreatic adenocarcinoma. The Company
is based in Houston, Texas and received a Product Development Award
from the Cancer Prevention & Research Institute of Texas
(CPRIT) in 2016. For more information, please visit
www.aravive.com.
Forward-Looking Statements
This communication contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. In some cases, forward-looking statements can be identified
by terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions and includes statements
regarding the expected enrollment of approximately 18 patients in
three dosing arms in the Phase 1b portion of the Phase 1b/2 trial
of AVB-500 in ccRCC, the expected enrollment of approximately 45
patients and investigation of the recommended AVB-500 dose
identified during the Phase 1b portion of the clinical trial in
combination with cabozantinib versus cabozantinib alone in the
open-label Phase 2 portion of the clinical trial and the potential
of AVB-500 to be combined with multiple anticancer therapies across
several tumor types. 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:
the ability to enroll the expected number of patients, 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 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, 2020, 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: Aulani Capuchin, Real Chemistry
acapuchin@realchemistry.com (559) 355-2673
Investors: Luke Heagle, Real
Chemistrylheagle@realchemistry.com (910) 619-5764
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