Aravive Announces Positive Updated Data and New Biomarker Data from Phase 1b Study of Batiraxcept in Clear Cell Renal Cell Carcinoma
March 03 2022 - 7:00AM
Aravive, Inc. (Nasdaq: ARAV), a late clinical-stage oncology
company developing targeted therapeutics to treat metastatic
disease, today announced positive new data from the Phase 1b
portion of the ongoing Phase 1b/2 trial of batiraxcept in clear
cell renal cell cancer (ccRCC) and new data from a biomarker high
subgroup.
As of February 4, 2022, 26 ccRCC patients have been treated with
batiraxcept at doses of 15 mg/kg (n=16) and 20 mg/kg (n=10), plus
cabozantinib 60 mg daily in previously treated (2L+) patients with
ccRCC. Demographics of the evaluated 26 patients are representative
of a 2L+ ccRCC population, with all patients having received a
prior immunotherapy. Key findings include:
- No dose limiting toxicities observed at either the 15 mg/kg or
20 mg/kg batiraxcept dose in combination with cabozantinib
- At a median follow-up of 4.9 months on February 4, 2022, 92% of
patients remain on study
- Best overall response rate (ORR) in the ITT population is 46%
(12/26)
- In the 15 mg/kg population, best ORR is 56% (9/16)
- In the 20 mg/kg population, best ORR is 30% (3/10)
- No patient has had progressive disease as their best
response
- The 6-month progression-free survival (PFS) rate in the ITT
population is 79%
- Median duration of response (DOR) has not been reached; the
3-month DOR is 100%
Biomarker DataAs previously reported, a key
finding from the Company’s Phase 1b trial of batiraxcept in
platinum-resistant ovarian cancer is an observable correlation of
baseline levels of serum soluble AXL (sAXL)/GAS6 to clinical
activity. As such, one of the objectives of the ongoing Phase 1b/2
ccRCC trial is to measure the correlation of baseline sAXL/GAS6
with radiographic response in patients with ccRCC treated with
batiraxcept plus cabozantinib. Ratios of sAXL/GAS6 were evaluated
retrospectively.
Among the 26 patients treated in the ccRCC trial, 25 were
evaluable for baseline sAXL/GAS6. A high ratio optimized a
patient’s ability to respond to batiraxcept plus cabozantinib. Key
findings from biomarker high patients include:
- Best ORR rate in the biomarker high
population is 63% (12/19)
- In the 15 mg/kg population, best ORR
is 75% (9/12)
- In the 20 mg/kg population, best ORR
is 43% (3/7)
- The 6-month PFS rate in the
biomarker high population is 77%, with a 6-month PFS rate of 91% in
the 15 mg/kg biomarker high group
- Median DOR has not been reached in
the biomarker high subgroup; the 3-month DOR is 100%
The safety and clinical activity data continue to support 15
mg/kg batiraxcept as an appropriate dose to study in combination
with cabozantinib in the Phase 2 ccRCC portion of the study.
“We are very encouraged by the best overall response rate and
6-month progression-free survival rate observed in the Phase 1b
trial of batiraxcept in patients with ccRCC,” said Kathryn
Beckermann, M.D., Ph.D., Assistant Professor, Division of
Hematology and Oncology, Vanderbilt University Medical Center, and
lead investigator for the trial. “These data are compelling as the
objective response rate in the cabozantinib alone groups of the
METEOR and CANTATA studies were 17% and 28%, respectively, and the
6-month progression-free survival rates for cabozantinib from these
studies ranged from 55-65%. Additionally, objective response rates
for other preferred National Comprehensive Cancer Network regimens
range from 25-37%. These early data suggest batiraxcept adds to
cabozantinib clinical activity and potentially provides a
much-needed therapy for this group of patients with refractory
clear cell renal cell carcinoma.”
About the Batiraxcept (AVB-500) Phase 1b/2 ccRCC
TrialThe Phase 1b trial is evaluating batiraxcept at doses
of 15 mg/kg and 20 mg/kg, plus cabozantinib 60 mg daily in
previously treated (2L+) patients with ccRCC. Prior treatment with
cabozantinib was not allowed. The primary objective is safety;
secondary and exploratory objectives include identification of the
recommended phase 2 dose (RP2D), objective response rate, and
duration of response (DOR). Given baseline levels of serum soluble
AXL (sAXL)/GAS6 correlated to clinical activity in the Company’s
Phase 1b trial of batiraxcept in platinum-resistant ovarian cancer,
one of the objectives of the ccRCC trial is to correlate baseline
sAXL/GAS6 with ORR in patients with ccRCC treated with batiraxcept
plus cabozantinib.
The open-label Phase 2 portion of the clinical trial initiated
earlier this year and is expected to enroll 55 patients across
three parts. Part A is expected to enroll approximately 25 patients
and 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 nivolumab and cabozantinib as a potential
front-line treatment for ccRCC. 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.
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
restoring 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). 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, and include statements
regarding the suggestion that batiraxcept adds to cabozantinib
clinical activity and potentially provides a much-needed therapy
for this group of patients with refractory clear cell renal cell
carcinoma, the expected enrollment in Part A of approximately 25
patients, Part B of approximately 20 patients and Part C of
approximately 10 patients with ccRCC. 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 potential of batiraxcept to serve as a breakthrough
therapy for this clear cell renal cell patient population, the data
from patients treated in the future with batiraxcept being
consistent with the results reported, 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
and ISTs, the clinical trials of batiraxcept 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 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. 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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