Aduro Announces First Patient Dosed in Phase 1 Study of ADU-S100 (MIW815) in Combination with YERVOY (ipilimumab) for the Tre...
February 11 2019 - 7:00AM
Aduro Biotech, Inc. (NASDAQ: ADRO) today announced that the first
patient has been dosed in a Phase 1 trial of ADU-S100 (MIW815), a
novel stimulator of interferon genes (STING) pathway activator, in
combination with YERVOY® (ipilimumab), an approved anti-CTLA-4
antibody for the treatment of relapsed and refractory melanoma. The
multicenter trial (see www.clinicaltrials.gov, identifier:
NCT02675439), which is part of an ongoing research and development
collaboration with Novartis, will enroll advanced melanoma patients
who have relapsed after or are refractory to treatment with
anti-PD-1 antibodies, nivolumab or pembrolizumab.
“We are pleased to initiate this study evaluating ADU-S100 with
ipilimumab in a homogeneous patient population. Despite recent
advancements in treating earlier stages of melanoma, the relapsed
and refractory patient segment remains underserved due to a lack of
therapeutic options. Based on their potential synergistic activity,
ADU-S100 in combination with an anti-CTLA-4 antibody could generate
a systemic adaptive immune response in patients with late-stage
melanoma,” commented Stephen Isaacs, chairman, president and chief
executive officer of Aduro Biotech. “As demonstrated leaders in the
STING pathway, we are committed to build upon the growing body of
data we’ve generated thus far, including encouraging clinical
signals demonstrated by ADU-S100 as a single agent and in
combination with spartalizumab, an investigational anti-PD-1
antibody.”
The protocol for investigation of ADU-S100 as a single agent was
amended to include evaluation of ADU-S100 in combination with
ipilimumab. During the ongoing dose escalation phase of the trial,
ipilimumab will be administered at its approved dose and schedule,
while the dose of ADU-S100 will be escalated. The dose expansion
phase of the trial will evaluate the optimized dose of ADU-S100 in
combination with ipilimumab in two expansion cohorts that will
enroll patients with cutaneously and viscerally accessible
melanoma.
As previously presented at the 2018 Society for Immunotherapy of
Cancer Annual Meeting, target engagement of ADU-S100 and activation
of the STING pathway was demonstrated in the ongoing Phase 1 dose
escalation of ADU-S100 alone through increases in key systemic
cytokines, IL-6, MCP-1 and IFN- β after administration. Partial
responses were observed in 4.9 percent of patients (n=2/41),
including one patient with parotid gland cancer who received prior
anti-PD-1 therapy. Stable disease (SD) was achieved in 26.8 percent
of patients (n=11/41), including five patients who had received
prior checkpoint inhibitor therapy. In the ongoing study of
ADU-S100 in combination with spartalizumab, clinical responses were
observed in several tumor types, including two patients who had
previously demonstrated responses to checkpoint inhibitor therapy
alone.
In preclinical models, activation of the STING pathway has been
shown to rapidly invoke an innate immune response, which
subsequently leads to a systemic and sustained adaptive immune
response through tumor-specific-CD8+ T cells. Ipilimumab may
further augment such immunity, by blocking the activity of the
checkpoint protein, CTLA-4, resulting in enhanced activity of T
cells that attack melanoma cells in the body, supported by the
demonstration of combined activity of ADU-S100 and anti-CTLA-4 in
preclinical models.
About STING Pathway Activator Technology The
Aduro-proprietary STING pathway activator product candidates,
including ADU-S100 (MIW815), are synthetic small molecule immune
modulators that are designed to target and activate human STING.
STING is generally expressed at high levels in immune cells,
including dendritic cells. Natural activation of STING is not
always sufficient to prevent the growth and spread of cancer cells.
In preclinical models, ADU-S100 directly activates STING to further
amplify the natural anti-tumor response. Once activated, the STING
receptor initiates a profound innate immune response through
multiple pathways, inducing the expression of a broad profile of
cytokines, including interferons and chemokines. This subsequently
leads to the development of a systemic tumor antigen-specific T
cell adaptive immune response.
Aduro’s lead molecule, ADU-S100, is the first therapeutic in
development specifically targeting STING. In collaboration with
Novartis, it is being tested in a Phase 1 clinical trial as a
single agent and in combination with ipilimumab, and in a Phase 1b
combination trial with spartalizumab (PDR001), an investigational
anti-PD-1 monoclonal antibody. These studies are enrolling patients
with cutaneously accessible, advanced/metastatic solid tumors or
lymphomas. The trials are evaluating the ability of ADU-S100 to
activate the immune system and recruit specialized immune cells to
attack the injected tumor, leading to a broad immune response that
seeks out and kills distant metastases.
About Aduro Aduro Biotech, Inc. is an
immunotherapy company focused on the discovery, development and
commercialization of therapies that are intended to transform the
treatment of challenging diseases. Aduro's technologies, which are
designed to harness the body's natural immune system, are being
investigated in cancer indications, autoimmune diseases and have
the potential to expand into infectious diseases. Aduro's STING
pathway activator technology is designed to activate the STING
receptor in immune cells, which may result in a potent
tumor-specific immune response. ADU-S100 (MIW815) is the first
STING pathway activator compound to enter the clinic and is
currently being evaluated in a Phase 1 clinical trial as a single
agent and in combination with ipilimumab and in a Phase 1b
combination trial with spartalizumab (PDR001), an investigational
anti-PD-1 monoclonal antibody. Aduro’s B-select monoclonal antibody
technology, including BION-1301, an anti-APRIL antibody, is
comprised of a number of immune modulating assets in research and
development. Aduro is collaborating with leading global
pharmaceutical companies to expand its products and technologies.
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 ADU-S100 for the
treatment of cancer, the potential for ADU-S100 in combination with
an anti-CTLA-4 antibody to generate a systemic adaptive immune
response in patients with late-stage melanoma, the timing and
volume of clinical data, our ability to continue as leaders in the
STING pathway and our ability to advance our drug development
programs on our own or with our collaborators. In some cases, you
can identify these statements by forward-looking words such as
“may,” “will,” “continue,” “anticipate,” “intend,” “could,”
“project,” “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,
early or preliminary clinical trial results may not be predictive
of future results, 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 technologies 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 September 30, 2018, 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.
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Investor
Relations Contact: |
Media
Contact: |
Noopur
Liffick |
Aljanae
Reynolds |
510-809-2465 |
510-809-2452 |
investors@aduro.com |
press@aduro.com |
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