Aravive Presents Updated Clinical Data at ASCO Showing Continued Best-in-Class Potential of Batiraxcept in Advanced or Metastatic clear cell Renal Cell Carcinoma (ccRCC)
May 26 2022 - 5:11PM
Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage
oncology company developing targeted therapeutics to treat
metastatic disease, today announced the presentation of updated
Phase 1b/2 ccRCC data at the 2022 American Society of Clinical
Oncology (ASCO) annual meeting, taking place June 3-7, 2022 in
Chicago. The abstract presents the updated response rate, landmark
progression-free-survival data, and biomarker data.
“We are jubilant about the selection of the poster on the use of
batiraxcept in 2L+ ccRCC for oral discussion at this year’s ASCO
annual meeting,” said Gail McIntyre, Ph.D., DABT, Chief Executive
Officer of Aravive. “This is a rare opportunity provided only to
select abstracts at this meeting. Batiraxcept continues to show
best-in-class potential in advanced or metastatic clear cell renal
carcinoma, platinum resistant ovarian cancer, and pancreatic
cancer. Enrollment in the registration directed Phase 3 program in
PROC remains on pace to complete this year and we look forward to
providing updates on the renal and pancreatic cancer programs
throughout 2022.”
Abstract Title: |
A Phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with
cabozantinib in patients with advanced or metastatic clear cell
renal cell carcinoma (ccRCC) who have received front-line treatment
(NCT04300140) |
Abstract Number: |
4511 (Poster Discussion Session – Data will be presented) |
Poster Session: |
Genitourinary Cancer—Kidney and Bladder |
Session Date: |
Poster Presentation: Saturday, June 4, 2022, 1:15 PM - 4:15 PM
CDTDiscussion: Saturday, June 4, 2022, 4:30 PM CDT (5:30 PM
EDT) |
Abstract Title: |
A Phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with
cabozantinib, cabozantinib and nivolumab, and as monotherapy in
patients with advanced or metastatic clear cell renal cell
carcinoma (NCT04300140) |
Abstract Number: |
TPS4599 (Trials in Progress poster – No data presented) |
Poster Session: |
Genitourinary Cancer—Kidney and Bladder |
Session Date: |
Saturday, June 4, 2022, 1:15 PM - 4:15 PM CDT |
Of note, 100% of patients had received a prior immunotherapy,
77% of the patients were in the IMDC (International Metastatic RCC
Database Consortium) Risk Score of intermediate or poor, and 39% of
the patients had received 2 or more prior lines of therapy prior to
study entry.
A summary of the interim Phase 1b results include (as of April
30, 2022, the cut-off date):
- Batiraxcept 15 mg/kg in combination with cabozantinib 60 mg has
a manageable safety profile in previously treated ccRCC; no
dose-limiting toxicities have been observed; a similar safety
profile was observed across the 15 mg/kg and 20 mg/kg dose
cohorts.
- Batiraxcept given every 2 weeks suppressed serum GAS6 to below
the level of quantitation in 25/26 patients (1 patient did not have
an assessment), showing a clear pharmacokinetic
(PK)/pharmacodynamic (PD) relationship; 23/26 patients had
batiraxcept trough levels above the minimally efficacious
concentration of 13.8 mg/L by Cycle 2.
- The confirmed + unconfirmed response rate in the total
population was 46% with a 50% confirmed response rate in the
15mg/kg (RP2D) batiraxcept group.
- The proportion of patients in the total population who were
progression free at 7 months was 71%.
- The proportion of patients in the total population who had a
duration of response of at least 7 months was 75%.
- A baseline biomarker enriched the confirmed response rate in
the RP2D (15mg/kg) biomarker high population to 67%, increased the
proportion of patients progression free at 7 months to 91% and
increased the proportion of patients who had a duration of response
of at least 7 months to 80%.
- 58% (15/26) of total population achieved a better response on
the batiraxcept trial than they did with their therapy prior to
study entry, which was only 23%.
- The safety and clinical activity of this combination together
with PK/PD data support a RP2D of 15 mg/kg.
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, inhibiting
metastasis, 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 European Commission in
PROC. 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). The Company is
based in Houston, Texas and received a Product Development Award
from the Cancer Prevention & Research Institute of Texas
(CPRIT) in 2016. Additional information at www.aravive.com.
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 development of the
biomarker offering the potential of a first in class targeted
therapy in renal cancer, having a registrational path for potential
accelerated approval as well as full approval of batiraxcept in 2L+
ccRCC, enrollment in the registration directed Phase 3 program in
PROC remaining on pace to complete this year and providing updates
on the renal and pancreatic cancer programs throughout 2022.
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 ability of the
biomarker to offer the potential of a first in class targeted
therapy in renal cancer, the ability to obtain accelerated approval
as well as full approval of batiraxcept in 2L+ ccRCC ; the ability
to report data from the current clinical trials in accordance with
current timelines, 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, 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; 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, 2021, 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.
Contact:Marek Ciszewski, J.D.Vice President,
Investor RelationsMarek@Aravive.com(562) 373-5787
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