Aduro Biotech Presents Early Observations From its Personalized Neoantigen-based pLADD Therapy Clinical Study at European Neo...
April 26 2018 - 8:00AM
Aduro Biotech, Inc. (Nasdaq:ADRO) today presented preliminary
observations from a case study of a patient with metastatic
colorectal cancer treated in Aduro’s ongoing Phase 1 study of its
personalized neoantigen-based immunotherapy (pLADD). This Phase 1
proof-of-concept study is designed to evaluate the safety and
tolerability of pLADD immunotherapy in adults with metastatic
colorectal cancer that is microsatellite stable (MSS). Data were
presented at the European Neoantigen Summit held in Amsterdam
(April 24-26, 2018).
The immunological data presented demonstrated that neoantigens
isolated and sequenced from the patient’s tissue samples, and
engineered into a personalized immunotherapy, induced
neoantigen-specific CD8+ T cells undetectable before pLADD
treatment started. In addition to adaptive immunity, pLADD induced
an innate response exemplified by gamma delta T cells, also thought
to be important for successful immunotherapy. The patient’s
neoantigens were selected using state-of-the-art algorithm
identification technology developed by Aduro’s collaborator,
Hanlee Ji, M.D., associate professor of medicine at
the Stanford University School of Medicine.
“Although early, the immunological data obtained from this case
study is encouraging, as it indicates that our pLADD immunotherapy
has the potential to induce a sustained, antigen-specific effect on
the immune system,” said Andrea van Elsas, Ph.D., chief scientific
officer of Aduro. “We believe our pLADD approach could offer a
differentiated treatment option to patients with MSS colorectal
cancer, who represent the vast majority of the colorectal cancer
patient population and who have not been responsive to immune
checkpoint inhibitors. In addition, these preliminary observations
support our plan to combine pLADD with checkpoint inhibitors, which
we believe could enhance the overall response in this patient
setting. We look forward to reporting additional immunological data
from this Phase 1 trial before the end of 2018.”
Preclinical data presented 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 antibody led to a sustained immune response and
significantly improved efficacy in these mouse tumor models.
Clinical Design of Phase 1 pLADD Trial in Adults with
Metastatic Corlorectal Cancer The Phase 1 single-arm
clinical trial (see www.clinicaltrials.gov,
identifier NCT03189030) is designed to evaluate the safety and
tolerability of a personalized immunotherapy using patient-specific
neoantigens and Aduro’s proprietary Listeria platform
technology. The trial is enrolling patients with metastatic
colorectal cancer that is microsatellite stable.
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 pLADD
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.
Aduro received an exclusive license (for use with Listeria based
therapetutics) to the proprietary bioinformatics algorithms and
computational workflows for neoantigen identification and selection
from Stanford University based on technology developed by Dr.
Hanlee Ji. The accurate identification of neoantigens, tumor
markers that are unique to an individual’s tumor, is believed to be
critical in the development of a patient-specific cancer
treatment. Aduro’s LADD technology, which has been shown in
clinical studies to remodel the tumor microenvironment, will be
used to create a patient-specific immunotherapy that is engineered
to enable the presentation of multiple selected neoantigens in
dendritic cells, with the aim of inducing a targeted, robust
anti-cancer immune response.
About Aduro Aduro Biotech, Inc. is an
immunotherapy company focused on the discovery, development and
commercialization of therapies that are intended 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 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
both a Phase 1 monotherapy study as well as a Phase 1b combination
study with an anti-PD1 immune checkpoint inhibitor. Aduro’s
B-select monoclonal antibody platform, including BION-1301, an
anti-APRIL antibody, is comprised of a number of immune modulating
assets in research and development. Aduro's pLADD program is based
on proprietary attenuated strains of Listeria that have been
engineered to express tumor neoantigens that are specific to an
individual patient’s tumor. Other Listeria strains for lung and
prostate cancers are being advanced by a partner. 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
StatementsThis 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 our
technology platforms, plans, anticipated timing for the
commencement and completion of various clinical trials and the
announcement of data relative to these trials 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,” “will,” “continue,” “plan,” “anticipate,” “intend,”
“could,” “project,” “seek,” “expect,” 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-K for
the year ended December 31, 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. We assume no obligation to update our
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Contact: |
Media Contact: |
Jennifer Lew |
Aljanae Reynolds |
Chief Financial
Officer |
510 809 2452 |
510 809 4816 |
press@aduro.com
|
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