Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage
biopharmaceutical company focused on developing therapies targeting
the Stimulator of Interferon Genes (STING) and A Proliferation
Inducing Ligand (APRIL) pathways for the treatment of cancer,
autoimmune and inflammatory diseases, today announced that its
license partner, Merck & Co., Inc. (known as MSD outside the
United States and Canada), presented data from an ongoing Phase 1
clinical trial of MK-5890, an anti-CD27 agonist. MK-5890 is being
evaluated as monotherapy and in combination with KEYTRUDA®
(pembrolizumab), an approved anti-PD-1 antibody, in adults with
advanced solid tumors. The findings were accepted as a
late-breaking abstract and presented by Dr. Ronnie Shapira-Frommer
as an oral presentation at the Society for Immunotherapy of Cancer
34th Annual Meeting (SITC 2019) in National Harbor, MD (Abstract
#O83).
“We are pleased with the clinical progress Merck has made to
date in the development of MK-5890, a candidate selected with the
same proprietary B-select monoclonal antibody technology at Aduro
that created BION-1301, an anti-APRIL antibody in development for
IgA nephropathy,” said Andrea van Elsas, Ph.D., chief scientific
officer of Aduro. “We are encouraged by the early antitumor
activity observed in patients with advanced solid tumors in both
the MK-5890 monotherapy and combination therapy arms. We look
forward to Merck’s further exploration of MK-5890’s potential in
expansion cohorts, including an arm of MK-5890 administered with
pembrolizumab, pemetrexed and carboplatin in patients with
non-squamous non-small cell lung cancer.”
Study Design and Findings for MK-5890 (Database cutoff
date: May 30, 2019)
In this Phase 1, open-label, multi-arm, multicenter,
dose-escalation clinical trial (see www.clinicaltrials.gov,
identifier NCT03396445), MK-5890 was administered to patients with
advanced solid tumors by intravenous (IV) infusion every three
weeks. Dose escalations for MK-5890 were 2 – 700 mg and
pembrolizumab was administered as an IV injection at a dose of 200
mg every three weeks. Patients receiving MK-5890 as monotherapy who
progressed while on therapy were eligible for crossover to the
MK-5890-pembrolizumab combination arm. Study objectives included
evaluation of safety, tolerability, pharmacodynamics,
pharmacokinetics and tumor responses evaluated using RECIST v1.1
criteria.
Interim data presented at SITC 2019 were based on findings from
25 patients enrolled in the MK-5890 monotherapy arm and 19 patients
enrolled in the combination arm with pembrolizumab. Fourteen
patients had crossed over from monotherapy to receive the
combination regimen. In the monotherapy arm, one patient achieved a
confirmed partial response with MK-5890. In the combination arm,
one patient achieved a confirmed partial response with MK-5890 and
pembrolizumab. In the crossover phase, two patients achieved
confirmed complete responses and two patients achieved confirmed
partial responses with MK-5890 and pembrolizumab. At the time of
analysis, two of the confirmed partial responses that crossed over
were ongoing and had lasted six months or longer.
In the initial phase, dose-limiting toxicities, all of which
were associated with infusion-related adverse events, were reported
in 12 percent (n=3/25) and 5.3 percent (n=1/19) of patients in
monotherapy and combination arms, respectively. Maximum tolerated
dose was defined as 200 mg every three weeks. Treatment with
MK-5890, alone and in combination with pembrolizumab, demonstrated
an acceptable safety profile. Grade 3 – 4 treatment-related adverse
events (TRAEs) were reported in 24 percent (n=6/25) and 21.2
percent (n=4/19) of patients in monotherapy and combination arms,
respectively. The most common TRAEs (occurring in ≥10% of patients)
in both study arms included: fatigue, infusion-related reaction,
nausea, pruritus, rash, myalgia and vomiting. In the combination
arm, additional TRAEs occurring in ≥10% of patients included:
chills, diarrhea, pyrexia, dry mouth, influenza-like illness and
increased amylase.
About CD27 and MK-5890 CD27 signaling plays a
role in cytotoxic T lymphocyte responses and the survival of
activated T cells. CD27 triggering enhances the priming of
cytotoxic T lymphocyte responses, thereby suggesting anti-CD27 is a
promising immunotherapeutic approach for treatment of cancers.
MK-5890 is a humanized agonist monoclonal antibody that binds to
CD27 to provide a costimulatory signal that enhances
T-cell-mediated responses. Preclinical data from syngeneic tumor
studies with a human CD27 knock-in mouse model have demonstrated
efficacy of MK-5890 as both monotherapy and in combination with
anti-PD-1. MK-5890 is currently being evaluated in a Phase 1
clinical trial for the treatment of advanced solid tumors (see
www.clinicaltrials.gov, identifier NCT03396445).
In 2014, Merck, through certain affiliates, entered into a
worldwide license agreement with Aduro for the development and
commercialization of anti-CD27 agonists, including MK-5890, which
was identified with Aduro’s proprietary B-select monoclonal
antibody technology.
About Aduro Aduro Biotech, Inc. is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of therapies that are designed to
harness the body’s natural immune system for the treatment of
patients with challenging diseases. Aduro’s product candidates in
the Stimulator of Interferon Genes (STING) and A Proliferation
Inducing Ligand (APRIL) pathways are being investigated in cancer,
autoimmune and inflammatory diseases. ADU-S100 (MIW815), which
potentially activates the intracellular STING receptor for a potent
tumor-specific immune response, is being evaluated in patients with
cutaneously accessible metastatic solid tumors or lymphomas.
BION-1301, a first-in-class humanized IgG4 monoclonal antibody that
fully blocks APRIL binding to both the BCMA and TACI receptors, is
being evaluated in IgA nephropathy. Aduro is collaborating with a
number of leading global pharmaceutical companies to help expand
and drive its product pipeline. 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 MK-5890, an anti-CD27 agonist alone
or in combination, the potential for our other therapies, our
eligibility to receive additional milestone payments or royalties
for MK-5890, Merck’s further exploration of MK-5890’s potential in
expansion cohorts, including an arm of MK-5890 administered with
pembrolizmab, pemetrexed and carboplatin in patients with
non-squamous non-small cell lung cancer, the further progress of
our and Merck’s clinical programs and our ability to expand and
drive our product pipeline alone or with 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, 2019, 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:Noopur
Liffick510-809-2465investors@aduro.compress@aduro.com
Aduro Biotech (NASDAQ:ADRO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Aduro Biotech (NASDAQ:ADRO)
Historical Stock Chart
From Jul 2023 to Jul 2024