Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology
company developing transformative therapeutics, and 3D
Medicines Inc., a China-based biopharmaceutical company developing
next-generation immuno-oncology drugs, today announced a
collaboration and exclusive license agreement for the development
and commercialization of AVB-500 across all oncology indications in
mainland China, Hong Kong, Macau, and Taiwan (Greater China).
AVB-500 is an ultra-high affinity decoy protein
that targets the GAS6-AXL signaling pathway associated with tumor
cell growth. Aravive successfully completed a Phase 1b trial of
AVB-500 in platinum resistant ovarian cancer and is also evaluating
AVB-500 in clear cell renal cell carcinoma.
“We believe 3D Medicines is an excellent partner
for the development and potential commercialization of AVB-500 in
China,” said Gail McIntyre, Ph.D., Chief Executive Officer of
Aravive. “3D Medicines has built a pipeline with both innovative
biological and small-molecule anti-tumor drugs and a professional
team with global development, registration and commercialization
capabilities. Following promising results from our Phase 1b trial
of AVB-500 in platinum resistant ovarian cancer, we are excited to
partner with 3D Medicines to potentially bring AVB-500 to patients
in China, expanding AVB-500 clinical indications and broadening our
geographic reach.”
Under the terms of the agreement, Aravive will
receive a signing payment of $12 million and be eligible to receive
up to $207 million in development and commercial milestone payments
with the potential for near term milestone payments of $6 million.
In addition, 3D Medicines will pay Aravive tiered royalties ranging
from the low double digits to mid-teens as a percentage of annual
net sales of AVB-500 in Greater China. 3D Medicines will be
responsible for all costs associated with development and
commercialization activities for AVB-500 in Greater China. Aravive
will retain all rights to AVB-500 in the rest of the world and will
continue to be responsible for the development and
commercialization of AVB-500 in the United States and other
geographies.
“We are very pleased to enter into this exclusive
collaboration with Aravive,” said John Gong, M.D., Ph.D., Chairman
and Chief Executive Officer of 3D Medicines. “We believe that
AVB-500, used in combination with existing standard of care
therapeutics or Envafolimab, an innovative subcutaneous PD-L1
antibody to be launched in China soon, could alter the treatment
paradigm across various tumor types. We are committed to working
closely with Aravive to further advance the development of AVB-500
and bring this important potential therapy to patients living with
cancer in China.”
BFC Group, Ltd. acted as advisors to Aravive,
Inc.
About AVB-500AVB-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 3D Medicines3D Medicines,
Inc. is a biopharmaceutical company at the stage of late clinical
development and early commercialization. With the concept “Help
people with cancer live longer and better,” aiming for the future
long-term survival of tumor patients, 3D Medicines focuses on the
development of differentiated next-generation immuno-oncology
drugs, to help cancer patients live longer with better quality of
life. 3D Medicines has built a pipeline with both innovative
biological and small-molecule anti-tumor drugs, and a professional
team with global development, registration and commercialization
capabilities. For more information, please
visit www.3d-medicines.com.
About AraviveAravive, Inc. is
a clinical-stage oncology company developing transformative
therapeutics designed to halt the progression of life-threatening
diseases. Aravive’s lead therapeutic, AVB-500, is an ultra-high
affinity decoy protein that targets the GAS6-AXL signaling pathway
associated with tumor cell growth. Aravive recently successfully
completed a Phase 1b trial of AVB-500 in platinum resistant ovarian
cancer and selected 15 mg/kg as the dose for the pivotal trial.
While the Phase 1b trial of AVB-500 in platinum resistant ovarian
cancer was a safety trial and not powered to demonstrate efficacy,
all 5 patients in the 15 mg/kg cohort experienced clinical benefit,
with 1 complete response, 2 partial responses, and 2 stable
disease. The Company also intends to initiate a Phase 1b/Phase 2
trial of AVB-500 in clear cell renal cell carcinoma later this
year. For more information, please visit www.aravive.com.
Forward-Looking StatementsThis
communication contains forward-looking statements (including within
the meaning of Section 21E of the United States Securities Exchange
Act of 1934, as amended, and Section 27A of the United States
Securities Act of 1933, as amended), express or implied, such
statements regarding 3D Medicines being an excellent partner for
the development and potential commercialization of AVB-500 in
China, potentially bringing AVB-500 to patients in China, with the
goal of improving the cancer treatment landscape across various
tumor types, the Company receiving up to $207 million in
development and commercial milestone payments under the terms of
the agreement, AVB-500, used in combination with existing standard
of care therapeutics, being able to alter the treatment paradigm
across various tumor types, and the Company initiating a Phase
1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma
later this year. 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:
whether the collaboration will be successful and result in any
development and commercial milestone payments or royalty payments
under the terms of the agreement, the ability to bring AVB-500 to
patients in China and improve the cancer treatment landscape across
various tumor types, , our ability to establish that AVB-500, used
in combination with existing standard of care therapeutics, is able
to alter the treatment paradigm across various tumor types, our
ability to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear
cell renal cell carcinoma as scheduled later this year, 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, 2019, 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.
Contacts:Media:Sheryl Seapy,
W2Osseapy@w2ogroup.com(213) 262-9390
Investors:Luke Heagle, W2Olheagle@w2ogroup.com(910)
726-1372
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