Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing transformative, targeted therapeutics to treat
life-threatening cancers, today announced that positive new data
from the Phase 1b portion of its open-label Phase 1b/2 trial
evaluating batiraxcept (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 on November 13, 2021. The presentation will
highlight interim safety, pharmacokinetic (PK), pharmacodynamic
(PD), and clinical activity data.
“We are encouraged by the preliminary performance of batiraxcept
in combination with cabozantinib in patients with clear cell renal
cell carcinoma,” said Gail McIntyre, Ph.D., DABT, Chief Executive
Officer of Aravive. “These results highlight the potential of
batiraxcept to improve outcomes for patients with advanced kidney
cancer. We look forward to sharing these new clinical data with the
research and medical community at this year’s SITC Annual
Meeting.”
As of July 21, 2021, seven patients received at least one dose
of batiraxcept 15 mg/kg in combination with cabozantinib, six
patients were ongoing treatment, and five patients were evaluable
for efficacy. No dose-limiting toxicities were observed. Trough
levels at cycle 1 day 15 were above the minimal efficacious
concentration identified from the Company’s model informed drug
development approach, and serum GAS6 levels were suppressed prior
to cycle 2 day 1. A best overall response of partial response was
observed in 3 of 5 patients (60%, unconfirmed as of July 21, 2021),
based on investigator assessment, RECIST v 1.1 criteria. In
addition, all patients demonstrated tumor decrease from
baseline.
Aravive’s presentation at the SITC Annual Meeting will include
updated safety, PK, PD, and clinical activity data from a larger
set of patients treated with batiraxcept 15 mg/kg in combination
with cabozantinib as of October 16, 2021.
Poster Presentation Details
Title: |
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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 |
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Presenter: |
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Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive |
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Date: |
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November 13, 2021 |
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Time: |
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7:00 AM – 8:30 PM ET |
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Location: |
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Hall E |
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For additional information, please visit the SITC
36th Annual Meeting website:
https://www.sitcancer.org/2021/home.
Conference Call InformationAravive will host a
conference call and webcast on November 12, 2021 at 8:30 a.m. ET to
discuss these clinical data. The conference call may be accessed by
dialing (877) 423-9813 (domestic) and (201) 689-8573
(international) and referring to conference ID 13724115. A webcast
of the conference call will be available in the Investors section
of the Aravive website at https://ir.aravive.com/. The archived
webcast will be available on Aravive’s website after the conference
call.
About the Batiraxcept (AVB-500) Phase 1b/2 ccRCC
TrialAravive initiated the Phase 1b portion of the Phase
1b/2 trial of batiraxcept 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 batiraxcept 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
batiraxcept 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 Batiraxcept (AVB-500)Batiraxcept 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, batiraxcept 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. Batiraxcept is currently being evaluated in
multiple clinical trials and has been granted Fast Track
designation by the U.S. Food and Drug Administration and orphan
drug designation by the European Commission in platinum resistant
recurrent ovarian cancer.
About AraviveAravive, Inc. is a
clinical-stage oncology company developing transformative, targeted
therapeutics to treat life-threatening cancers. The Company is
currently evaluating its lead therapeutic, batiraxcept (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 StatementsThis 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 potential of
batiraxcept (AVB-500) to improve outcomes for patients with
advanced kidney cancer. 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 data from patients treated in the future with batiraxcept being
consistent with the results reported, 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 batiraxcept,
batiraxcept’s ability to have favorable results in clinical trials
and ISTs, the clinical trials of batiraxcept 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 batiraxcept 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 batiraxcept; if batiraxcept 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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