Aravive Announces Initiation of Investigator-Sponsored Phase 1/2 Study of AVB-500 in Combination with Avelumab in Patients wi...
March 24 2020 - 8:00AM
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage biopharmaceutical
company, announced that the first patient has been dosed in an
investigator-sponsored Phase 1/2 clinical trial of the company’s
GAS6/AXL inhibitor AVB-500 in combination with PD-L1 inhibitor
avelumab in patients with advanced urothelial carcinoma (UC). The
study is being led by Abhishek Tripathi, M.D., Assistant Professor
of Medicine, Section of hematology/oncology at the University of
Oklahoma Stephenson Cancer Center.
“Locally advanced or metastatic urothelial carcinoma is an
aggressive cancer with poor long-term survival,” said Dr. Tripathi.
“Although immunotherapy results in durable responses in some
patients, only a small proportion of patients respond and most
eventually progress. Targeting additional mechanisms of
immunosuppression and tumor growth such as GAS6/AXL signaling could
be synergistic with immunotherapy and may improve outcomes in this
challenging disease.”
The COAXIN study is a multi-center, single arm, Phase 1/2 trial
evaluating safety and preliminary antitumor efficacy of avelumab in
combination with AVB-500 in patients with advanced UC. The trial
starts with a Phase 1 cohort to establish the maximum tolerated
dose (MTD) of AVB-500 in combination with avelumab and to allow for
assessment of potential dose-limiting toxicities. The primary
endpoint of the study is objective response rate. Secondary outcome
measures include progression free survival, clinical benefit rate,
duration of response and overall survival. The trial is listed on
clinicaltrials.gov NCT04004442. Patient enrollment and
continuation on study may be impacted by COVID-19.
About Urothelial CancerGlobally, urothelial
cancer accounts for approximately 450,000 new cancer cases and
165,000 deaths every year (World Cancer Report, 2013).
Platinum-based combination chemotherapy has been the cornerstone of
treatment for patients with incurable metastatic disease.
Gemcitabine and cisplatin (GC) and conventional or dose-dense
methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) are the
commonly utilized regimens in this setting. Although initial
responses are seen in approximately 40% of patients, most
eventually experience disease progression. A significant proportion
of patients are ineligible for cisplatin due to suboptimal renal
function, poor performance status, congestive heart failure,
neuropathy or hearing loss. Until recently, single agent
chemotherapy or best supportive care were the only treatment
options for such patients and the median overall survival (OS) was
around 5 to 7 months.
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 doing so,
AVB-500 selectively inhibits the GAS6-AXL signaling pathway. In
preclinical studies, GAS6-AXL inhibition has shown anti-tumor
activity, both as a single agent and 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 is correlated to poor prognosis and survival, and has been
implicated in therapeutic resistance to conventional
chemotherapeutics and targeted therapies.
Aravive reported positive data from the first 31 patients
enrolled in the Phase 1b portion of a Phase 1b/2 clinical trial of
AVB-500 in platinum-resistant recurrent ovarian cancer. AVB-500
continues to be well tolerated. An investigator-sponsored Phase 1/2
trial of AVB-500, in combination with durvalumab in patients with
platinum-resistant recurrent epithelial ovarian cancer, is also
ongoing. Based on AVB-500’s safety profile and specifically
targeted mechanism of action, this drug candidate has the potential
to be used both in combination with existing therapies, as well as
a maintenance drug. The U.S. Food and Drug Administration granted
Fast Track Designation to AVB-500 in platinum-resistant recurrent
ovarian cancer.
About Aravive Aravive, Inc. (Nasdaq: ARAV) is a
clinical-stage biopharmaceutical company developing treatments
designed to halt the progression of life-threatening diseases,
including cancer and fibrosis. Aravive’s lead product candidate,
AVB-500, is an ultra-high affinity decoy protein that targets the
GAS6-AXL signaling pathway. By capturing serum GAS6, AVB-500
starves the AXL pathway of its signal, potentially halting the
biological programming that promotes disease progression. AXL
receptor signaling plays an important role in multiple types of
malignancies by promoting metastasis, cancer cell survival,
resistance to treatments, and immune suppression. The GAS6-AXL
signaling pathway also plays a significant role in fibrogenesis.
Aravive is evaluating AVB-500 in platinum-resistant ovarian cancer,
clear cell renal cell carcinoma and kidney fibrosis and intends to
expand development into additional oncology and fibrotic
indications. Aravive 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 (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 as targeting
additional mechanisms of immunosuppression and tumor growth such as
Gas6/AXL signaling could be synergistic with immunotherapy and may
improve outcomes in this challenging disease, the potential of
AVB-500 to be used both in combination with existing therapies, as
well as a maintenance drug, the potential of AVB-500 to halt the
biological programming that promotes disease progression and the
expansion of the development of AVB-500 into additional oncology
and fibrotic indications. 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 expand development in 2020 into additional
oncology and fibrotic indications, the Company’s dependence upon
AVB-500, AVB-500’s ability to have favorable results in clinical
trials, the clinical trials of AVB-500 having results that are as
favorable as those of preclinical and clinical studies, 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 outbreak; 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 and Form 10-K/A for the fiscal year
ended December 31, 2018, 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 for Aravive:
Investors:Christina TartagliaStern Investor
Relationschristina@sternir.com
Media:Heidi Chokeir, Ph.D.Canale
Communicationsheidi@canalecomm.com 619-203-5391
Source: Aravive
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