- Combination Immunotherapeutic Regimen Designed to Enhance Cancer
Fighting Competency of Immune Cells -
BERKELEY, Calif.--(BUSINESS WIRE)--Aduro Biotech, Inc. today announced the initiation of an
investigator-sponsored Phase 2 clinical trial of the company’s
immuno-oncology product candidates GVAX Pancreas and CRS-207 in
combination with Bristol-Myers Squibb’s Opdivo (nivolumab), a monoclonal
antibody against programmed death-1 receptor (PD-1). The first patient
has been enrolled in the trial that will be conducted at up to five U.S.
clinical trial sites.
“For some time, we have recognized and embraced the power of combination
strategies for immuno-oncology and this trial will evaluate expanding
our lead combination to include Opdivo, the first-in-class anti-PD-1”
GVAX Pancreas and CRS-207 are designed to stimulate an immune response
against a tumor, and nivolumab is designed to remove an
immuno-suppressive mechanism that cancer cells have developed against
the immune system. Aduro believes the combination of CRS-207 and GVAX
Pancreas with nivolumab may improve clinical outcomes because of their
complementary mechanisms of action.
The randomized, controlled STELLAR trial (Safety and Therapeutic
Efficacy of Live-attenuated Listeria/GVAX with Anti-PD1
Regimen) will enroll approximately 88 adults with metastatic
pancreatic cancer who have had one prior chemotherapy regimen for
metastatic disease. The trial will include two arms: Arm A with
CRS-207/GVAX Pancreas vaccine and nivolumab and Arm B with CRS-207/GVAX
Pancreas vaccine. The primary objective of this study is to compare the
overall survival (OS) of patients in Arm A and Arm B. Secondary
endpoints include evaluation of clinical and immune response and safety.
For more information, please visit ClinicalTrials.gov (Identifier:
NCT02243371).
The trial is supported by Stand up to Cancer (SU2C)-Lustgarten
Foundation Pancreatic Cancer Convergence Dream Team Translational
Research; Pancreatic Cancer Action Network – AACR Research Acceleration
Network Grant, supported by Fredman Family Foundation; and Bristol-Myers
Squibb. SU2C is a program of the Entertainment Industry Foundation.
“For some time, we have recognized and embraced the power of combination
strategies for immuno-oncology and this trial will evaluate expanding
our lead combination to include Opdivo, the first-in-class anti-PD-1,”
said Stephen T. Isaacs, chairman, president and chief executive officer
of Aduro. “While we continue our efforts to evaluate GVAX Pancreas and
CRS-207 in our Phase 2b ECLIPSE trial as an effective treatment for
pancreatic cancer, we look forward to generating data in yet another
combination for potential future applications of our technologies.”
“The Pancreatic Cancer Action Network is thrilled to have provided
initial funding that has been leveraged for this important program,”
said Julie Fleshman, president and CEO of the Pancreatic Cancer Action
Network. “In an effort to double pancreatic cancer survival by 2020, we
are investing in projects that have the potential to improve the
treatment landscape of pancreatic cancer and ultimately increase
survival.”
“Stand Up To Cancer is excited not only that this immunotherapy clinical
trial has begun patient enrollment, one of the 120 clinical trials we
have launched or completed,” stated SU2C President and CEO Sung Poblete,
R.N, Ph.D., “but that it involves collaboration by two distinct
biotechnology firms to study the combination of two proprietary
immunotherapies. Stand Up To Cancer is proud to have facilitated this
level of multi-institutional and corporate collaboration, which is at
the core of SU2C’s research model and its mission to benefit cancer
patients faster.”
Last year, the U.S. Food and Drug Administration (FDA) granted
Breakthrough Therapy designation for Aduro’s pancreatic cancer
combination treatment consisting of CRS-207 and GVAX Pancreas. According
to the FDA, a Breakthrough Therapy designation is for a drug candidate
that treats a serious or life-threatening condition and for which
preliminary clinical evidence indicates that the drug may demonstrate
substantial improvement on a clinically significant endpoint over
available therapies.
Separately, Aduro is currently conducting a 240 patient Phase 2b
clinical trial (ECLIPSE;
identifier NCT02004262) in metastatic pancreatic cancer patients who
have received at least one line of therapy. The randomized, controlled
3-arm trial will involve approximately 20 clinical trial sites in the
United States and Canada and will evaluate the safety, immune response
and efficacy of the combination immunotherapy of GVAX Pancreas in
combination with CRS-207 compared to chemotherapy or to CRS-207 as a
monotherapy. The primary endpoint of the trial is overall survival.
About CRS-207
CRS-207 is one of a family of product candidates based on Aduro’s
live-attenuated, double-deleted (LADD) Listeria monocytogenes
immuno-oncology platform that are designed to induce potent innate and
adaptive immune responses. CRS-207 has been engineered to express the
tumor-associated antigen mesothelin, which is over-expressed in many
cancers including mesothelioma and pancreatic, non-small cell lung,
ovarian and gastric cancers.
About GVAX Pancreas
GVAX Pancreas is one of a family of GVAX vaccines derived from human
cancer cell lines that are genetically modified to express
granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune
system-stimulating cytokine. GVAX Pancreas is derived from human
pancreatic cancer cell lines and is designed to activate specific T cell
immunity to pancreatic cancer antigens, including mesothelin.
About the Stand Up To Cancer Initiative
Stand Up To Cancer (SU2C) raises funds to accelerate the pace of
research to get new therapies to patients quickly and save lives now.
SU2C, a program of the Entertainment Industry Foundation (EIF), a
501(c)(3) charitable organization, was established in 2008 by film and
media leaders who utilize the industry’s resources to engage the public
in supporting a new, collaborative model of cancer research, and to
increase awareness about cancer prevention as well as progress being
made in the fight against the disease. As SU2C’s scientific partner, the
American Association for Cancer Research (AACR) and a Scientific
Advisory Committee led by Nobel Laureate Phillip A. Sharp, PhD, conduct
rigorous, competitive review processes to identify the best research
proposals to recommend for funding, oversee grants administration, and
provide expert review of research progress.
About the Pancreatic Cancer Action Network
The Pancreatic Cancer Action Network is the national organization
creating hope in a comprehensive way through research, patient support,
community outreach and advocacy for a cure. The organization is leading
the way to increase survival for people diagnosed with this devastating
disease through a bold initiative — The Vision of Progress: Double
Pancreatic Cancer Survival by 2020. Together, we can Wage Hope in the
fight against pancreatic cancer by intensifying our efforts to heighten
awareness, raise funds for comprehensive private research, and advocate
for dedicated federal research to advance early diagnostics and better
treatments and increase chances of survival. For more information, go to .
About Aduro
Aduro Biotech, Inc. is a private, clinical-stage immuno-oncology company
focused on the development of technology platforms to stimulate an
immune response against cancer. Aduro’s lead platform is based on
proprietary strains of live-attenuated, double-deleted (LADD) Listeria
monocytogenes that induce a potent innate immune response and have
been engineered to express tumor-associated antigens to induce
tumor-specific T cell-mediated immunity. Aduro has received Breakthrough
Therapy designation from the FDA for its lead LADD regimen, CRS-207 in
combination with GVAX Pancreas in pancreatic cancer. The company is
evaluating the proprietary immuno-oncology combination in the ongoing
Phase 2b ECLIPSE clinical trial and has additional ongoing clinical
trials with its LADD platform in mesothelioma and glioblastoma. The
company is also developing clinical candidates using synthetic small
molecule immune modulators that are designed to activate the
intracellular STING receptor, a central mediator of the innate immune
response. For more information, please visit .
Contacts
Aduro Biotech, Inc.Sylvia Wheeler, 510-809-9264SVP,
Corporate AffairsorMedia Contact:Angela Bitting,
925-202-6211a.bitting@comcast.net
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