Aravive to Present Phase 1b Data Evaluating AVB-500 in Platinum Resistant Ovarian Cancer at 2021 Society of Gynecologic Oncol...
March 12 2021 - 7:00AM
Aravive, Inc. (Nasdaq:ARAV), a clinical-stage oncology company
developing transformative therapeutics, today announced that
updated data from its Phase 1b trial evaluating AVB-500 in platinum
resistant ovarian cancer (PROC) will be presented at the 2021
Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.
Additionally, a trial in progress poster will be presented on an
open label Phase 1/2 investigator-sponsored trial of AVB-500 in
combination with durvalumab in patients with platinum resistant,
recurrent epithelial ovarian cancer. The meeting is being held
virtually on March 19-25, 2021.
Oral Presentation Details: |
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Title: |
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Phase 1 Study of GAS6/AXL
Inhibitor (AVB-500) in Recurrent, Platinum Resistant Ovarian
Carcinoma |
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Presenter: |
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Katherine Fuh, MD, Associate
Professor in Obstetrics and Gynecology, Washington University
School of Medicine |
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Date: |
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March 19, 2021 |
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Time: |
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2:35 PM CT |
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Session: |
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Scientific Plenary I: Innovation
and Progress in Gynecologic Oncology |
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Poster
Presentation Details: |
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Title: |
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Phase I/II study of AVB-S6-500 in
Combination with Durvalumab (MEDI4736) in Patients with
Platinum-Resistant, Recurrent Epithelial Ovarian Cancer |
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Authors: |
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Emily Hinchcliff, Shannon N.
Westin, Virginia Bayer, Weiyi Peng, Linghua Wang, Bryan Fellman,
Ying Yuan, Anil Sood, Karen Lu, Amir Jazaeri |
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Date: |
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March 19-25, 2021 |
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Time: |
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8:00 PM – 11:00 PM CT |
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Session: |
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TiP Poster Session |
“Results from the Phase 1b trial evaluating AVB-500 in PROC, for
which new treatment options are urgently needed, are very
encouraging in light of the improved progression free survival and
duration of response, coupled with the tolerable safety profile,”
said Reshma Rangwala, MD, PhD, Chief Medical Officer of Aravive.
“We remain focused on advancing the ongoing pivotal Phase 3 trial
of AVB-500 to address the unmet needs of patients with ovarian
cancer.”
For additional information, please visit the Society of
Gynecologic Oncology Annual Meeting on Women’s Cancer website:
www.sgo.org.
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 and clear cell renal 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 transformative 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 product candidate, 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. 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 plans to advance the
ongoing pivotal Phase 3 trial of AVB-500. 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 advance the
ongoing pivotal Phase 3 trial of AVB-500, 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,
2019, 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:Media:Sheryl Seapy,
W2Osseapy@w2ogroup.com(213) 262-9390
Investors:Luke Heagle, W2Olheagle@w2ogroup.com(910) 726-1372
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