Aduro Biotech Announces First Patient Dosed in Phase 1 Clinical Trial of Personalized Immunotherapy pLADD Based on Proprietar...
September 27 2017 - 8:01AM
Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with
three distinct immunotherapy technologies, announced today that the
first patient has been dosed in the Phase 1 clinical trial (see
www.clinicaltrials.gov, identifier NCT03189030) designed to
evaluate the safety and tolerability of a personalized live,
attenuated double-deleted Listeria monocytogenes (pLADD)
immunotherapy for adults with metastatic colorectal cancer that is
microsatellite stable (MSS). The personalized immunotherapy
has been engineered with patient-specific neoantigens that were
identified and selected using state-of-the-art neoantigen
identification technology developed by Hanlee Ji, M.D., associate
professor of medicine at the Stanford University School of
Medicine.
“Our pLADD program leverages our extensive capabilities relating
to the use of Listeria as a delivery mechanism for cancer antigens
and Dr. Ji’s innovative neoantigen technology used to identify
immunogenic antigens specific for an individual patient,” said
Natalie Sacks, M.D., chief medical officer of Aduro Biotech.
“Together, we believe these two cutting edge technologies represent
a new approach to treating patients who have relapsed following
prior chemotherapy. We look forward to evaluating initial
proof-of-concept in this Phase 1 clinical trial.”
Clinical Design of Phase 1 PLADD Trial in Adults with
Metastatic Corlorectal Cancer The Phase 1 clincial
single-arm trial is designed to evaluate the safety and
tolerability of a personalized immunotherapy made using
patient-specific antigens and Aduro’s proprietary live, attenuated,
double-deleted Listeria monocytogenes platform technology.
The trial is seeking to enroll approximately 10 patients with
metastatic colorectal cancer that is MSS. Patients will
receive their patient-specific immunotherapy once every three
weeks.
About pLADD Personalized LADD, or pLADD, is a
second-generation LADD technology that is designed to leverage the
immune-activating activity of the Listeria bacterial vector in
combination with neoantigens, which are unique, patient-specific
tumor markers exclusively expressed in an individual’s tumor
cells. Once administered, pLADD therapies are expected to
mobilize the immune system in two ways--first, through the
immediate recognition of the presence of Listeria as being foreign,
and subsequently, through a specific and customized immune attack
on cells containing the tumor neoantigens presented by
pLADD.
To create a patient-specific pLADD therapy, a physician begins
by removing tumor cells from the patient. These cells are
analyzed in order to molecularly characterize (sequence) the tumor,
including any mutations that are unique to the patient’s own tumor
cells. Predictive algorithms for antigen processing are run to
identify pertinent tumor antigens. Aduro then creates a LADD strain
engineered to enable the presentation of multiple selected
neoantigens in dendritic cells, with the aim of inducing a
targeted, robust anti-cancer immune response.
Preclinical Data with pLADD Preclinical data
showed that mouse pLADD strains targeting tumor-specific
neoepitopes induced a robust immune response, including induction
of cytokines, chemokines, and antigen-specific CD8+ T cells.
In preclinical models of pLADD, remodeling of the tumor
microenvironment with an increase in the CD8:Treg ratio was
observed. The combination of pLADD with an anti PD-1 agent led to a
sustained immune response and significantly improved efficacy in
these mouse tumor models.
About Aduro Aduro Biotech, Inc. is an
immunotherapy company focused on the discovery, development and
commercialization of therapies that transform the treatment of
challenging diseases. Aduro's technology platforms, which are
designed to harness the body's natural immune system, are being
investigated in cancer indications and have the potential to expand
into autoimmune and infectious diseases. Aduro's LADD technology
platform is based on proprietary attenuated strains of Listeria
that have been engineered to express tumor-associated antigens to
induce specific and targeted immune responses. This platform is
being developed as a treatment for multiple indications, including
mesothelioma, gastric, ovarian, lung and prostate cancers.
Additionally, a personalized form of LADD, or pLADD, is being
developed utilizing tumor neoantigens that are specific to an
individual patient’s tumor. Aduro's STING Pathway Activator
platform is designed to activate the STING receptor in immune
cells, resulting in a potent tumor-specific immune response.
ADU-S100 is the first STING Pathway Activator compound to enter the
clinic and is currently being evaluated in a Phase 1 study in
patients with cutaneously accessible metastatic solid tumors or
lymphomas. Aduro’s B-select monoclonal antibody platform is
comprised of a number of immune modulating assets in research and
preclinical development, including BION-1301, an anti-APRIL
antibody. Aduro is collaborating with leading global pharmaceutical
companies to expand its products and technology platforms. For more
information, please visit www.aduro.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include
statements regarding our intentions or current expectations
concerning, among other things, the potential for pLADD and our
technology platforms, the potential for the neoantigen
identification technology that we are using for the pLADD program,
our plans, the timing and availability of results of our clinical
trials and those of our collaborators, the timing and receipt of
milestone payments, and the potential for eventual regulatory
approval of our product candidates. In some cases, you can identify
these statements by forward-looking words such as “may,” “believe,”
“will,” “continue,” “anticipate,” “intend,” “could,” “project,”
“expect,” “targeted” or the negative or plural of these words or
similar expressions. Forward-looking statements are not
guarantees of future performance and are subject to risks and
uncertainties that could cause actual results and events to differ
materially from those anticipated, including, but not limited to,
our history of net operating losses and uncertainty regarding our
ability to achieve profitability, our ability to develop and
commercialize our product candidates, our ability to use and expand
our technology platforms to build a pipeline of product candidates,
our ability to obtain and maintain regulatory approval of our
product candidates, our ability to operate in a competitive
industry and compete successfully against competitors that have
greater resources than we do, our reliance on third parties, and
our ability to obtain and adequately protect intellectual property
rights for our product candidates. We discuss many of these risks
in greater detail under the heading “Risk Factors” contained in our
quarterly report on Form 10-Q for the quarter ended June 30, 2017,
which is on file with the Securities and Exchange Commission. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release.
Contact:
Sylvia Wheeler
SVP, Corporate Affairs
510 809 9264
Media Contact:
Susan Lehner
510 809 2137
press@aduro.com
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