Aravive and AstraZeneca Announce Initiation of Randomized Phase 1/2 Study of AVB-500 in Combination with Durvalumab in Patien...
13 November 2019 - 12:00AM
Aravive, Inc. (Nasdaq: ARAV) and AstraZeneca (NYSE: AZN) today
announced that an investigator-sponsored Phase 1/2 clinical trial
of AVB-500, a GAS6/AXL inhibitor, in combination with durvalumab, a
PD-L1 inhibitor, in patients with platinum-resistant, recurrent
epithelial ovarian cancer has initiated and is recruiting patients.
The clinical trial is jointly funded by Aravive and
AstraZeneca.
“GAS6/AXL signaling plays a key role in immune evasion,
suggesting that inhibition of this pathway has the potential to
augment the anti-tumor effects of an anti-PD-L1 agent to achieve
better outcomes for patients,” said Gail McIntyre, Ph.D., chief
scientific officer of Aravive. “Consequently, we believe there is a
strong mechanistic and clinical rationale for exploring the
potential of AVB-500 in combination with a checkpoint inhibitor in
the treatment of ovarian cancer.”
This open-label trial will begin with a Phase 1b
safety lead-in phase to determine the recommended Phase 2 dose
(RP2D) for the combination of AVB-500 and durvalumab. In the Phase
2 portion, eligible subjects will participate in a 6-week
monotherapy cycle randomized to either AVB-500 or durvalumab before
receiving the combination therapy at the RP2D. Patients will
receive treatment until progression or unacceptable toxicity with
combination therapy. The study is listed on clinicaltrials.gov
NCT04019288.
“There is a significant need for effective
treatments that don’t add to the treatment burden for women with
ovarian cancer,” said Laura Bonifacio, Pharm.D., Ph.D., vice
president of clinical operations at Aravive.
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.
About AVB-500AVB-500 (previously 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 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. AVB-500 continues to
be well tolerated with no dose limiting toxicities. A Phase 1
clinical trial in healthy volunteers (NCT03401528) investigating
the safety, pharmacokinetics, and pharmacodynamics of AVB-500 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, 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,
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 Statements This 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 belief
that there is a strong mechanistic and clinical rationale for
exploring the potential of AVB-500 in combination with a checkpoint
inhibitor in the treatment of ovarian cancer, the suggestion that
inhibition of the GAS6-AXL pathway has the potential to augment the
anti-tumor effects of an anti-PD-L1 agent to achieve better
outcomes for patients, 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 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 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 Tartaglia
Stern Investor Relations
christina@sternir.com
Media:
Heidi Chokeir
Canale Communications
heidi@canalecomm.com
619-203-5391
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