Aravive Achieves Second Development Milestone from 3D Medicines
July 15 2021 - 7:00AM
Aravive Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing innovative therapeutics to treat life-threatening
diseases, today announced that it achieved a $3 million development
milestone payment from its licensee, 3D Medicines Inc. This
milestone is based on the Center for Drug Evaluation (CDE) of the
China National Medical Products Administration (NMPA) approval of
the Investigational New Drug (IND) application submitted by 3D
Medicines Inc. to participate in Aravive’s international AVB-500
Phase 3 platinum resistant ovarian cancer (PROC) clinical trial.
Gail McIntyre, Ph.D., DABT, Chief Executive Officer, said, “We
have a strong partnership with 3D Medicines, and we are
enthusiastic about the progress they have made with development of
AVB-500 (3D-299) in China. Our companies are dedicated and working
together to improve patient survival and bring hope to women with
advanced ovarian cancer, and we plan to have patients from China
included in our Phase 3 PROC trial along with patients from our
approximately 165 sites in North America and Europe. This IND
approval by the CDE in China is the second development milestone
achieved by Aravive since we entered into our agreement with 3D
Medicines in November 2020.”
Aravive’s collaboration and license agreement with 3D Medicines
Inc. is for the development and commercialization of AVB-500 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 $3 million development
milestone, the company received a $6 million development milestone
payment in June 2021 related to the first patient dosed by Aravive
in the AVB-500 Phase 3 registrational clinical trial for platinum
resistant ovarian cancer in the United States, and a $12 million
upfront payment in 2020, totaling $21 million that has been
achieved by Aravive from 3D Medicines.
About the Phase 3 PROC TrialThe global,
randomized, double-blind, placebo-controlled adaptive trial
(GOG-3059/ENGOT OV-66) is designed to evaluate efficacy and safety
of AVB-500 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 165
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. A prospectively defined interim analysis will
determine whether randomization will continue with all patients,
regardless of prior bevacizumab treatment, or only with patients
medically ineligible to receive bevacizumab or who choose not to
receive bevacizumab. 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 AVB-500 AVB-500 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, AVB-500 selectively inhibits the GAS6-AXL
signaling pathway, which is upregulated in multiple cancer types
including ovarian cancer. 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. AVB-500 is
currently being evaluated in clinical trials and has been granted
Fast Track Designation by the U.S. Food and Drug Administration in
platinum resistant recurrent ovarian cancer. Analysis of all safety
data to date showed that AVB-500 has been generally well-tolerated
with no dose-limiting toxicities or unexpected safety signals.
About AraviveAravive, Inc. is a
clinical-stage oncology company developing innovative therapeutics
to treat life-threatening diseases. Aravive’s lead therapeutic,
AVB-500, is a first-in-class ultra-high affinity decoy protein that
targets the GAS6-AXL signaling pathway associated with tumor cell
growth, tumor metastasis, resistance to treatment and decreased
survival. AVB-500 has the potential to be combined with multiple
anti-cancer therapies across several tumor types, due to its novel
mechanism of action and favorable safety profile. AVB-500 has been
granted Fast Track Designation by the U.S. Food and Drug
Administration in platinum resistant recurrent ovarian cancer. The
Company is currently evaluating AVB-500 in a registrational Phase 3
trial in platinum resistant ovarian cancer and a Phase 1b/2 trial
in second line plus, clear cell renal cell carcinoma. Aravive plans
to initiate a Phase 1b/2 trial evaluating AVB-500 in first-line
treatment of pancreatic cancer in the second half of 2021. The
Company 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 StatementsThis 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 165 sites in
North America and Europe, the potential of AVB-500 to be combined
with multiple anti-cancer therapies across several tumor types, due
to its novel mechanism of action and favorable safety profile and
plans to initiate a Phase 1b/2 trial evaluating AVB-500 in
first-line treatment of pancreatic cancer in the second half of
2021. 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
initiate a Phase 1b/2 trial evaluating AVB-500 in first-line
treatment of pancreatic cancer in the second half of 2021,the
ability to combine AVB-500 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 AVB-500,
AVB-500's ability to have favorable results in clinical trials and
ISTs, the clinical trials of AVB-500 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 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
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.
Contact: Joseph T. SchepersVP, Investor
Relations, Aravive, Inc. jschepers@aravive.com(770) 558-5517
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