Aravive Receives Third Development Milestone from 3D Medicines
10 Ottobre 2022 - 10:05PM
Aravive Inc. (Nasdaq: ARAV), a late clinical-stage oncology company
developing innovative therapeutics to treat life-threatening
diseases, today announced that it received a $6 million development
milestone payment from its licensee, 3D Medicines Inc. This
milestone is based on the initiation of the global Phase 3 platinum
resistant ovarian cancer (PROC) clinical trial in China for the
development of Aravive’s batiraxcept.
Gail McIntyre, Ph.D., DABT, Chief Executive
Officer, said, “Our partnership with 3D Medicines continues with
positive progress as they move forward with enrollment in the Phase
3 Trial for batiraxcept (3D-299) in China. Their enrollment of
patients will support Aravive’s potential marketing application for
batiraxcept in the United States, as well as their potential
marketing application in China. This is our third milestone
achieved since entering our agreement with 3D Medicines in November
2020 and we look forward to continued advancement towards the
potential approval of batiraxcept in both the United States and
China. Our companies are dedicated and working together to improve
patient survival and bring hope to women with advanced ovarian
cancer.”
Aravive’s collaboration and license agreement
with 3D Medicines Inc. is for the development and commercialization
of batiraxcept in oncology indications in Greater China. Under the
terms of the agreement, Aravive is eligible to receive up to an
aggregate of $207 million in development and commercial milestone
payments and royalties. In addition to achieving this $6 million
development milestone, the Company had previously received a $9
million in development milestones related to development of
batiraxcept for platinum resistant ovarian cancer in the United
States and China, as well as a $12 million upfront payment in 2020,
totaling $27 million that has been achieved by Aravive from 3D
Medicines.
About the Phase 3 PROC Trial
The global, randomized, double-blind,
placebo-controlled trial (GOG-3059/ENGOT OV-66) is designed to
evaluate efficacy and safety of batiraxcept at a dose of 15 mg/kg
in combination with paclitaxel. The trial is expected to
enroll approximately 300-400 patients with high-grade serous
ovarian cancer who have received one to four prior lines of therapy
at approximately 150 sites in North America, Europe, and Asia. The
primary endpoint for the trial is progression free-survival and the
secondary endpoint is overall survival. Exploratory endpoints
include objective response rate, duration of response, quality of
life, clinical benefit rate, pharmacokinetic and pharmacodynamic
profile, and sAXL/GAS6 ratio. This trial is being conducted in
partnership with The GOG Foundation, Inc. (GOG-F), through the GOG
Partners program in the USA, and in partnership with the European
Network for Gynaecological Oncological Trial (ENGOT) groups in
Europe. The Phase 3 trial is listed on
clinicaltrials.gov NCT04729608.
About Aravive
Aravive, 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.
This 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 have patients from China included in
the Company’s Phase 3 PROC trial along with patients from the
Company’s approximately 150 sites in North America and Europe, that
the Company is eligible to receive up to an aggregate of $207
million in development and commercial milestone payments and
royalties from 3D Medicines and the Company’s ability to receive
regulatory approval of batiraxcept. 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 to combine batiraxcept with multiple
anti-cancer therapies across several tumor types; 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 batiraxcept; batiraxcept's ability to have
favorable results in clinical trials and investigator sponsored
trials (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; and 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, the Company’s Quarterly Reports on
Form 10-Q for the fiscal quarters ended March 31, 2022 and June 30,
2022, respectively, 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:ir@aravive.com
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