Aduro Biotech Announces Clinical Collaboration with Merck to Evaluate the Combination of Aduro’s CRS-207 with Merck’s KEY...
May 17 2017 - 9:05AM
Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with
three distinct immunotherapy technologies, announced today the
expansion of its clinical collaboration with Merck (known as MSD
outside the United States and Canada) to include an additional
Phase 2 clinical trial. The companies will investigate the
combination of CRS-207, Aduro’s LADD (live, attenuated
double-deleted) based immunotherapy, with KEYTRUDA®
(pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of
patients with malignant pleural mesothelioma (MPM) whose disease
progressed following prior treatment. Earlier this year, Aduro
announced a Phase 2 clinical collaboration with Merck, through a
subsidiary, to evaluate the combination of CRS-207 with
pembrolizumab for the treatment of gastric cancer.
“Data from our ongoing Phase 1 clinical trial of CRS-207 with
standard chemotherapy as frontline treatment for malignant pleural
mesothelioma have been very encouraging, including disease control
in 94 percent of patients treated with the CRS-207/chemotherapy
combination,” said Natalie Sacks, M.D., chief medical officer at
Aduro. “Based on these clinical data, as well as data from
preclinical studies that demonstrate synergistic activity of
CRS-207 and anti-PD-1 therapy, we look forward to initiating a
Phase 2 trial to evaluate the CRS-207/pembrolizumab combination in
patients with malignant pleural mesothelioma who have failed prior
treatment.”
The multicenter, single-arm, open-label Phase 2 study is
designed to evaluate the safety and efficacy of CRS-207 with
pembrolizumab in adults with previously treated MPM. The
trial is expected to involve approximately 35 patients who have
failed one to two prior treatments.
About Malignant Pleural Mesothelioma
Mesothelioma is a form of cancer that affects the smooth layer of
mesothelial cells that surround the chest, lungs, heart and
abdomen. Malignant pleural mesothelioma, which affects the thin
balloon-shaped lining of the lungs, is the most common form of this
disease and accounts for approximately 13,000 cases a year in the
United States, European Union and Japan. MPM is an aggressive
disease with a poor prognosis. Most MPM patients are not candidates
for surgical resection. Currently, there is no U.S. Food and Drug
Administration-approved therapy for second- or third-line treatment
of MPM.
About LADD and CRS-207 LADD is Aduro's
proprietary platform of live, attenuated double-deleted Listeria
monocytogenes strains that have been engineered to generate an
innate immune response and to express tumor-associated antigens to
induce tumor-specific T cell-mediated immunity. CRS-207, the
company’s lead LADD product candidate, 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, endometrial and gastric
cancers.
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, 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 includes a number of immune modulating
assets in research and preclinical development. 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 combination of CRS-207 with
pembrolizumab for the potential treatment of mesothelioma and
gastric cancer, the potential for our technology platforms, plans,
the timing of our planned clinical 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,” “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-QK for the quarter ended March
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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc. Kenilworth, NJ,
USA.
Contact:
Sylvia Wheeler
SVP, Corporate Affairs
510 809 9264
Media Contact:
Susan Lehner
510 809 2137
press@aduro.com
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