Aravive Reports Preliminary Results of AVB-500 from the First Cohort of the Phase 1b/Phase 2 Recurrent Platinum Resistant Ova...
July 31 2019 - 7:05AM
Aravive Inc. (Nasdaq: ARAV) today announced that preliminary
efficacy data from their ongoing clinical trial with AVB-500 showed
compelling anti-tumor activity in the 12 patients treated
from the first cohort of the ongoing Phase 1b portion of the Phase
1b/2 trial of AVB-500 in patients with platinum-resistant recurrent
ovarian cancer where response to standard of care chemotherapy
alone in patients is typically 10-15 percent.
The open-label, Phase 1b safety lead-in portion of the efficacy
and safety study of AVB-500 in patients with platinum-resistant
recurrent ovarian cancer enrolled patients into two cohorts, one
investigating a combination of AVB-500 with pegylated liposomal
doxorubicin (PLD) and the other, a combination of AVB-500 with
paclitaxel (PAC). The overall best response rate (ORR) in the
AVB-500 combination cohorts to date by investigator determined
RECIST v1.1 criteria was greater than response rates observed
historically with standard of care chemotherapy alone in this
clinical setting. The company therefore has decided to expand
enrollment in the Phase 1b portion of the study to validate the
unanticipated early positive efficacy signal.
The company plans to present the detailed safety,
pharmacokinetic, pharmacodynamic and preliminary efficacy results
for this cohort at an upcoming scientific meeting.
“We have decided to expand the clinical trial to validate that
early positive efficacy signal,” said Laura Bonifacio, PharmD,
Ph.D, Vice President of Aravive. “If we continue to see a robust
efficacy signal, we plan to work with FDA to explore the most
efficient regulatory pathway to bring this drug to the patients in
need. We continue to pursue our other pipeline programs, including
renal cell carcinoma and renal fibrosis” added Bonifacio.
About Ovarian CancerEach year in the United
States, more than 22,000 women develop ovarian cancer and there are
approximately 14,240 attributed deaths annually, making ovarian
cancer the deadliest of gynecologic malignancies. Clinical studies
over time have shown little response to treatment, especially for
platinum-resistant ovarian cancer. In fact, on average, only 10-15
percent of patients with platinum-resistant ovarian cancer have an
objective response to currently approved therapies (Davis et al.
Gynecologic Oncology 133 (2014) 624–631). Clearly, there is a need
to develop new therapeutic strategies to improve the overall
survival of patients who face less than optimal outcomes due to
metastasis and treatment resistant ovarian cancer.
About AVB-500 AVB-500 (previously called
AVB-S6-500) 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 or
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.
A Phase 1 clinical trial in healthy volunteers (NCT03401528)
investigating the safety, pharmacokinetics, and pharmacodynamics
was completed last year. The study met the safety and tolerability
endpoints and demonstrated clinical proof-of-mechanism for AVB-500
in neutralizing GAS6. Based on AVB-500’s favorable safety
profile, coupled with its specifically targeted mechanism of
action, the protein has the potential to be used both in
combination with existing therapies, as well as a maintenance drug.
U.S. FDA granted Fast Track Designation to Aravive Biologics’
AVB-S6-500 in platinum-resistant recurrent ovarian cancer in
2018.
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 has
initiated the Phase 1b portion of a Phase 1b/2 clinical trial of
AVB-500 combined with standard of care therapies in patients with
platinum-resistant ovarian cancer, 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. Aravive was one of
FierceBiotech's Fierce 15 in 2017. For more information,
please visit www.aravive.com.
Forward Looking Statements
This press release 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 Company's goals, intentions and
expectations as to future plans or events, including statements
regarding the plans to present the detailed safety,
pharmacokinetic, pharmacodynamic and preliminary efficacy results
for the first cohort at an upcoming scientific meeting, the
potential for AVB-500 to be used both in combination with existing
therapies, as well as a maintenance drug, plans to work with FDA to
explore the most efficient regulatory pathway to bring this drug to
the patients in need, the continued pursuit of the Company’s other
pipeline programs, including renal cell carcinoma and renal
fibrosis. 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 2019 into additional oncology and
fibrotic indications, the Company’s dependence upon AVB-500,
AVB-500’s ability to have favorable results in clinical trials or
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 Quarterly Reports on Form 10-Q,
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:
Vinay Shah
CFO
Aravive Inc.
Vinay@aravive.com
Media:
Heidi Chokeir
Canale Communications
heidi@canalecomm.com
619-203-5391
Aravive (NASDAQ:ARAV)
Historical Stock Chart
From Aug 2024 to Sep 2024
Aravive (NASDAQ:ARAV)
Historical Stock Chart
From Sep 2023 to Sep 2024