Aravive Announces First Patient Dosed in Phase 2 Study of Batiraxcept in Clear Cell Renal Cell Carcinoma
January 31 2022 - 7:00AM
Aravive, Inc. (Nasdaq: ARAV), a late clinical-stage oncology
company developing targeted therapeutics to treat metastatic
disease, today announced that the Company has dosed the first
patient in the Phase 2 portion of the Phase 1b/2 study of
batiraxcept for the treatment of clear cell renal cell carcinoma
(ccRCC).
“Safety and preliminary activity data from the Phase 1b study of
batiraxcept in combination with cabozantinib in patients with 2L+
ccRCC gives us confidence to initiate the Phase 2 portion of the
trial and expand the study to additional cohorts,” said Gail
McIntyre, Ph.D., DABT, Chief Executive Officer of
Aravive. “I’m grateful to our team for their diligence and
dedication to expedite the ccRCC program. The data reported to date
shows clinically relevant benefit of adding batiraxcept to the
current standard of care in ccRCC without adding to the toxicity
profile. We will continue to update the ongoing Phase 1b portion of
the study as data mature and anticipate providing clinical activity
and safety updates of the P2 portion of the study throughout
2022.”
The Phase 2 portion of the Phase 1b/2 clinical trial of
batiraxcept in ccRCC is an open-label study in which 55 patients
are anticipated to enroll across three parts. Part A is expected to
enroll approximately 25 patients and will investigate batiraxcept
15 mg/kg in combination with cabozantinib in 2L+ ccRCC patients.
Part B is expected to enroll approximately 20 patients and evaluate
batiraxcept 15 mg/kg in combination with standard of care nivolumab
and cabozantinib in first-line ccRCC patients. Part C is expected
to evaluate batiraxcept 15 mg/kg monotherapy in approximately 10
patients with ccRCC who are not eligible for curative intent
therapies. The primary endpoint of each part of the Phase 2 portion
of the trial is objective response rate (“ORR”) and key secondary
endpoints include duration of response (“DOR”), progression free
survival (“PFS”), and overall survival (“OS”). Additional
information on the trials: NCT04300140.
About Batiraxcept (AVB-500)Batiraxcept 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, batiraxcept selectively
inhibits the GAS6-AXL signaling pathway, which is upregulated in
multiple cancer types including ovarian, renal and pancreatic. 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. Batiraxcept is currently being evaluated in
multiple clinical trials and has been granted Fast Track
designation by the U.S. Food and Drug Administration and orphan
drug designation by the European Commission in platinum resistant
recurrent ovarian cancer.
About AraviveAravive, Inc. is a
late clinical-stage oncology company developing targeted
therapeutics to treat metastatic disease. Our lead product
candidate, batiraxcept (formerly AVB-500), is an ultra-high
affinity decoy protein that binds to GAS6, the sole ligand that
activates AXL, thereby inhibiting metastasis and tumor growth, and
restores sensitivity to anti-cancer agents. Batiraxcept has been
granted Fast Track Designation by the U.S. FDA and Orphan Drug
Designation by the European Commission in platinum-resistant
recurrent ovarian cancer. Batiraxcept is in an active
registrational Phase 3 trial in platinum resistant ovarian cancer
(NCT04729608), a Phase 1b/2 trial in clear cell renal cell
carcinoma (NCT04300140), and a Phase 1b/2 trial in pancreatic
adenocarcinoma (NCT04983407). A P1B platinum-resistant ovarian
cancer trial demonstrated more than a doubling of progression-free
survival in a patient subgroup that represents the ongoing P3
population. Additional information at www.aravive.com.
Contact:Marek Ciszewski,
J.D.Vice President, Investor Relationsmarek@aravive.com (562)
373-5787
Forward Looking StatementsThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 on
our current expectations and projections about future events. 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. These statements are based
upon current beliefs, expectation, and assumptions and include
statements regarding continuing to update the ongoing Phase 1b
portion of the study as data mature and providing clinical activity
and safety updates of the Phase 2 portion of the study throughout
2022, enrollment of 55 patients in the Phase 2 portion of the Phase
1b/2 clinical trial of batiraxcept in ccRCC three parts, Part A
enrolling approximately 25 patients and investigating batiraxcept
15 mg/kg in combination with cabozantinib in 2L+ ccRCC patients,
Part B enrolling approximately 20 patients and evaluating
batiraxcept 15 mg/kg in combination with standard of care nivolumab
and cabozantinib in first-line ccRCC patients and Part C evaluating
batiraxcept 15 mg/kg monotherapy in approximately 10 patients with
ccRCC who are not eligible for curative intent therapies. These
statements are subject to risks and uncertainties, including the
ability to enroll the expected number of patients, 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 indications, the Company's dependence
upon batiraxcept, batiraxcept’s ability to have favorable results
in 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 batiraxcept 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 batiraxcept; if batiraxcept 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 and other
factors described in Aravive’s filings with the SEC. 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, 2020, 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.
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