Aravive Announces Positive Initial Results from Phase 1b Portion of the Phase1b/2 Study of AVB-500 in Combination with Caboza...
June 24 2021 - 7:00AM
Aravive Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing innovative therapeutics to treat life-threatening
diseases, today announced positive initial results from the Phase
1b portion of its Phase 1b/2 study in patients dosed with 15mg/kg
of AVB-500 in combination with cabozantinib who have clear cell
renal cell carcinoma (advanced stage kidney cancer). The data in
three evaluable patients showed that AVB-500 was well tolerated
with no unexpected findings.
Based on the pharmacokinetics, pharmacodynamics, and safety data
at 15mg/kg of AVB-500, and approval by the Data and Safety
Monitoring Board (DSMB), the Company plans to expand the dosing of
15mg/kg of AVB-500 to an additional three patients to determine the
potential of initiating the Phase 2 portion with this dose. The
Company also expects to continue to investigate higher doses of
AVB-500 in the Phase 1b to obtain additional safety,
pharmacokinetics, and pharmacodynamics information.
“We are pleased to announce the favorable results in the first
cohort of our clear cell renal cell carcinoma Phase 1b study, as we
continue to advance AVB-500 and evaluate its ability to address an
urgent, high unmet medical need in patients with advanced kidney
cancer who have very low survival rates,” said Gail McIntyre,
Ph.D., Chief Executive Officer of Aravive. “We continue to focus on
difficult-to-treat life threatening cancers with AVB-500, and in
addition to our clear cell renal cell carcinoma clinical trial, our
lead indication in paclitaxel resistant ovarian cancer is in a
Phase 3 clinical trial, and we recently announced that we plan to
initiate a Phase 1b/2 clinical trial in first-line metastatic
pancreatic cancer in the second half of this year. We are
enthusiastic about the clinical data with AVB-500 in combination
with anticancer therapies that continue to show consistent PK/PD
data and a favorable safety profile. These combinations may have
the potential to be used in a range of different cancers.”
About the AVB-500 Phase 1b/2 Clinical Trial in Clear
Cell Renal Cell Carcinoma (ccRCC)
Aravive initiated its Phase1b 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
up to a total of 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 up to 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 will enroll patients with
advanced clear cell renal cell carcinoma (ccRCC) who have
progressed on front-line treatment. The Phase 1b/2 trial is listed
on clinicaltrials.gov NCT04300140.
About AVB-500 AVB-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 Aravive Aravive, Inc. is a clinical-stage
oncology company developing innovative therapeutics designed to
halt the progression of life-threatening diseases. Aravive is based
in Houston, Texas and received a Product Development Award from the
Cancer Prevention & Research Institute of Texas (CPRIT) in
2016. 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 successfully completed a
Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and
has initiated a registrational Phase 3 trial of AVB-500 at a dose
of 15 mg/kg. 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 is dosing patients in
its Phase 1b/2 trial in clear cell renal cell carcinoma. 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 plans to expand the dosing of 15mg/kg of AVB-500 to an
additional three patients to determine the potential of initiating
the Phase 2 portion with this dose, investigating higher doses of
AVB-500 in the Phase 1b to obtain additional safety,
pharmacokinetics, and pharmacodynamics information, plans to
initiate a Phase 1b/2 clinical trial in first-line metastatic
pancreatic cancer in the second half of this year and the expected
enrollment of the Phase 1b and Phase 2 portion of the trial of
AVB-500 in ccRCC . 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 Company’s ability to recruit for and enroll the expected number
of patients into the Phase 1b and Phase 2 3 trial of AVB-500 in
ccRCC as planned and continue dosing as planned 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, 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.
Contact: Joseph T. SchepersVP, Investor
Relations, Aravive, Inc. jschepers@aravive.com(770) 558-5517
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