Aravive Receives IND Clearance for Phase 1b/Phase 2 Clinical Trial of AVB-500 in Patients with Clear Cell Renal Cell Carcinom...
14 January 2020 - 12:00AM
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage biopharmaceutical
company, today announced that the U.S. Food and Drug Administration
(FDA) has cleared the company’s Investigational New Drug (IND)
application for investigation of the company’s lead candidate,
AVB-500, for the treatment of clear cell renal cell carcinoma
(ccRCC).
“The rapidly changing landscape of front line metastatic ccRCC
has created a clinical need for studies in the second-line
setting,” said Brian Rini, M.D, Ingram Professor of Medicine,
Vanderbilt-Ingram Cancer Center (VICC), Nashville, TN.
“Investigation into the role of AXL in RCC to build on VEGF
inhibition in this setting is an exciting new frontier in RCC
research.”
“Preclinical data demonstrate that inactivation of AXL/GAS6
pathway via treatment with AVB-500 in ccRCC cells plays a key role
in both anti-tumor and anti-metastatic effects,” said Gail
Mcintyre, Ph.D., chief scientific officer of Aravive.
The study has a Phase 1b safety portion and a Phase 2
randomized, controlled portion. The Phase 1b portion will
investigate the safety and tolerability of escalating doses of
AVB-500 in combination with cabozantanib in patients with advanced
clear cell renal cell carcinoma that have progressed with or were
intolerant to front-line treatment. The primary endpoints for the
Phase 1b portion of the clinical trial are safety, pharmacokinetic
and pharmacodynamic measurements with secondary endpoints including
preliminary activity measures. The Phase 2 portion of the study
will investigate the recommended AVB-500 dose identified during the
Phase 1b portion in combination with cabozantinib versus
cabozantinib alone in patients with advanced clear cell renal cell
carcinoma that have progressed with or were intolerant to
front-line treatment. The primary endpoint will be progression free
survival. The clinical trial will also explore AVB-500 effects on
biomarkers (GAS6) in serum.
About ccRCCKidney cancer is a leading cause of
cancer-related deaths in the United States and is among the 10 most
common cancers in both men and women. Metastasis to distant organs
including the lung, bone, liver and brain is the primary cause of
death in kidney cancer patients as only 12% of metastatic kidney
cancer will survive past 5 years. According to the American Cancer
Society, it is estimated that there will be approximately 73,750
new cases of kidney cancer in the U.S. and 14,830 people will die
from this disease in 2020.
Preclinical studies have demonstrated there is a molecular link
between the tumor suppressor gene VHL that is mutated in more than
80% of ccRCC tumors and AXL expression in RCC. The expression of
the receptor tyrosine kinase AXL in tumors has been postulated as a
biomarker and increased mRNA levels of AXL is associated with poor
prognosis in renal cell cancer.
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 expansion cohort in the
Phase 1b portion of a Phase 1b/2 clinical trial of AVB-500 in
platinum-resistant recurrent ovarian cancer. An
investigator-sponsored Phase 1 study of AVB-500, in combination
with durvalumab in patients with platinum-resistant recurrent
epithelial ovarian cancer, is also ongoing. A Phase 2a trial in
renal fibrosis initiated late 2019. 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 AraviveAravive, 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
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, concerning 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 and results
that are as favorable as those of preclinical 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; 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.com619-203-5391
Source: Aravive
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