Aravive Announces First Patient Dosed in Phase 1b/2 Clinical Trial of AVB-500 for the Treatment of Pancreatic Adenocarcinoma
August 09 2021 - 7:00AM
Aravive Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing innovative therapeutics to treat life-threatening
diseases, today announced the Company has dosed the first patient
in the Phase 1b portion of its Phase 1b/2 trial of AVB-500 in
combination with gemcitabine and nab-paclitaxel as a first-line
treatment in patients with advanced or metastatic pancreatic
adenocarcinoma. The Phase 1b portion of the clinical trial will
evaluate safety, tolerability, pharmacokinetics, pharmacodynamics,
and clinical activity of AVB-500 in combination with gemcitabine
and nab-paclitaxel.
“We are pleased with the quick advancement of AVB-500 with the
first patient dosed in our Phase 1b/2 pancreatic adenocarcinoma
trial. This clinical trial addresses a very high unmet medical need
in one of the most difficult-to-treat cancers with a high mortality
rate,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of
Aravive. “We continue to expand the development of AVB-500, as the
Company now has three ongoing clinical trials of AVB-500. In
addition to the pancreatic adenocarcinoma clinical trial, AVB-500
is currently being investigated in a Phase 3 clinical trial for
platinum resistant ovarian cancer and a Phase 1b/2 clinical trial
for clear cell renal cell carcinoma.”
The Phase 1b/2 clinical trial is designed to evaluate AVB-500 as
a first-line therapy in combination with gemcitabine and
nab-paclitaxel (Abraxane®) in patients with advanced or metastatic
pancreatic adenocarcinoma eligible to receive gemcitabine and
nab-paclitaxel combination therapy. The Phase 1b portion of the
clinical trial will evaluate safety, tolerability,
pharmacokinetics, pharmacodynamics, and clinical activity in
approximately 20 patients dosed with 15 mg/kg of AVB-500 in
combination with gemcitabine and nab-paclitaxel. The randomized,
controlled Phase 2 portion of the clinical trial is designed to
evaluate approximately 60 patients dosed with 15 mg/kg of AVB-500
as a first-line therapy in combination with gemcitabine and
nab-paclitaxel versus gemcitabine and nab-paclitaxel alone. The
primary endpoint of the Phase 2 portion of the trial is
progression-free survival. The secondary endpoints are objective
response rate, duration of response, clinical benefit rate, safety
and overall survival, and the exploratory endpoints are
pharmacokinetics and pharmacodynamics. The Phase 1b/2 trial is
listed on clinicaltrials.gov NCT04983407.
About Pancreatic CancerPancreatic cancer is the
seventh leading cause of cancer death worldwide. There were
approximately 495,800 new cases of pancreatic cancer and 466,000
deaths from the disease worldwide in 2020. It is estimated that
there will be approximately 60,400 new cases of pancreatic cancer
and 48,200 deaths from the disease in the U.S. in 2021. Pancreatic
cancer typically has a poor prognosis, and the five-year survival
rate is approximately 11%. Pancreatic adenocarcinoma is the most
common type of pancreatic cancer, and there is a clear, high, unmet
medical need to improve patient survival with new effective
treatments that are safe and well-tolerated. Pancreatic cancer is
projected to become the third leading cause of cancer death
worldwide by 2025 and the second leading cause of cancer death in
the U.S. by 2030.
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. AVB-500 has been
granted Fast Track Designation by the U.S. Food and Drug
Administration in platinum resistant recurrent ovarian cancer. 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 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 pancreatic cancer
statistical data 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.
Contact:Joseph T. SchepersVP, Investor
Relations, Aravive, Inc.jschepers@aravive.com (770) 558-5517
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