LEXINGTON, Mass., March 7, 2022 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
of innovative therapeutics for the treatment of cancer, today
announced that a manuscript has been published in the peer-reviewed
journal Gastroenterology, authored by Curis collaborators at
Washington University School of
Medicine in St. Louis, on the role
of IRAK4 in pancreatic ductal adenocarcinoma (PDAC) and the
preclinical efficacy of emavusertib (CA-4948), a novel, small
molecule IRAK4 inhibitor, in combination with checkpoint
immunotherapy.
"Through our emavusertib clinical trials, we have seen the
potential of targeting IRAK4 in indications like non-Hodgkin's
lymphoma, acute myeloid leukemia and myelodysplastic syndromes,"
said James Dentzer, President and
Chief Executive Officer of Curis. "Given the early, but compelling
preclinical data outlined in Gastroenterology, IRAK4
targeting may have a broader application in treating solid tumors
such as pancreatic cancer. We are thrilled to continue to identify
new opportunities to potentially expand the development of
emavusertib into additional cancer types as we work towards our
goal of delivering novel, innovative cancer therapeutics in areas
with significant unmet patient need."
The manuscript titled "IRAK4 signaling drives resistance to
checkpoint immunotherapy in pancreatic ductal adenocarcinoma"
concluded that tumor IRAK4 drives T-cell exhaustion in PDAC and is
a promising therapeutic target when combined with checkpoint
immunotherapy. Specifically, the experiments demonstrated that
IRAK4 controls the NF-kB pathway and production of multiple
checkpoint ligands, suppressive chemokines/cytokines, as well as
hyaluronan synthase 2, all of which suppress T cell immune function
against cancer. The study demonstrated that in a genetic mouse
model that develops highly aggressive pancreatic cancer, IRAK4 can
be targeted to overcome the immunosuppressive tumor
microenvironment and drive response to checkpoint immunotherapy and
validate the study of CA-4948 as a means to improve
immunotherapeutic response in pancreatic cancer. The study team
further confirmed this finding by generating a genetic mouse model
in which the IRAK4 gene is deleted from the pancreatic
cancer, providing firm evidence that IRAK4 is a promising
therapeutic target in this deadly disease.
"Historically, the tumor microenvironment's strong defense
mechanisms have made cancers such as PDAC nearly impossible to
treat effectively. Checkpoint immunotherapies, which have had a
groundbreaking impact on other areas of oncology, are largely
ineffective in PDAC," said Dr. Kian-Huat
Lim, MD, PhD, Associate Professor of Medicine at
Washington University School of
Medicine, and Director of the GI Oncology Program. "Given the role
of IRAK4 in NF-kB activation, we sought to explore whether there
could be a translational benefit to targeting IRAK4 in PDAC. The
results of our preclinical study show the promising effects of
targeting IRAK4 in combination with chemotherapy and checkpoint
immunotherapy, highlighting the potential of emavusertib to deliver
effective therapeutic options to pancreatic cancer patients, who
continue to have very limited therapeutic options."
The manuscript is available online at
https://www.gastrojournal.org/article/S0016-5085(22)00201-3/pdf.
About Emavusertib (CA-4948)
Emavusertib is an IRAK4 kinase inhibitor and IRAK4 plays an
essential role in the toll-like receptor (TLR) and interleukin-1
receptor (IL-1R) signaling pathways, which are frequently
dysregulated in patients with AML and MDS. Third parties have
recently discovered that the long form of IRAK4 (IRAK4-L) is
oncogenic and preferentially expressed in over half of patients
with AML and MDS. The overexpression of IRAK4-L is believed to be
driven by a variety of factors, including specific spliceosome
mutations such as SF3B1 and U2AF1.
About Curis, Inc.
Curis is a biotechnology company focused on the development of
innovative therapeutics for the treatment of cancer. In 2015, Curis
entered into a collaboration with Aurigene in the areas of
immuno-oncology and precision oncology. As part of this
collaboration, Curis has exclusive licenses to oral small molecule
antagonists of immune checkpoints including the VISTA/PDL1
antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as
the IRAK4 kinase inhibitor, emavusertib (CA-4948).
Emavusertib is currently undergoing testing in the Phase 1/2
TakeAim Lymphoma trial, in patients with non-Hodgkin's lymphoma
both as a monotherapy and in combination with BTK inhibitor
ibrutinib. Curis is also evaluating emavusertib in the Phase
1/2 TakeAim Leukemia trial in patients with acute myeloid leukemia
and myelodysplastic syndromes, for which it has received Orphan
Drug Designation from the U.S. Food and Drug Administration. In
addition, Curis is engaged in a collaboration with ImmuNext for
development of CI-8993, a monoclonal anti-VISTA antibody, which is
currently undergoing testing in a Phase 1 trial in patients with
solid tumors. Curis is also party to a collaboration with
Genentech, a member of the Roche Group, under which Genentech and
Roche are commercializing Erivedge® for the treatment of advanced
basal cell carcinoma. For more information, visit Curis's website
at www.curis.com.
Forward-Looking Statements:
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995, including, without limitation, any statements concerning
product research, development, clinical trials and studies and
commercialization plans, timelines, anticipated results or the
therapeutic potential of drug candidates including any statements
regarding the activity, safety and tolerability of emavusertib
(CA-4948) and any preclinical findings including potential
combinations and indications; and statements of assumptions
underlying any of the foregoing. Forward-looking statements
may contain the words "believes," "expects," "anticipates,"
"plans," "intends," "seeks," "estimates," "assumes," "predicts,"
"projects," "targets," "will," "may," "would," "could," "should,"
"continue," "potential," "focus," "strategy," "mission," or similar
expressions. These forward-looking statements are not guarantees of
future performance and involve risks, uncertainties, assumptions
and other important factors that may cause actual results to be
materially different from those indicated by such forward-looking
statements. For example, Curis may experience adverse results,
delays and/or failures in its drug development programs and may not
be able to successfully advance the development of its drug
candidates in the time frames it projects, if at all. Curis's drug
candidates may cause unexpected toxicities, fail to demonstrate
sufficient safety and efficacy in clinical studies and/or may never
achieve the requisite regulatory approvals needed for
commercialization. Favorable results seen in preclinical studies
and early clinical trials of Curis's drug candidates may not be
replicated in later trials. There can be no guarantee that the
collaboration agreements with Aurigene and ImmuNext, or the CRADA
with NCI, will continue for their full terms, that Curis or its
collaborators will each maintain the financial and other resources
necessary to continue financing its portion of the research,
development and commercialization costs, or that the parties will
successfully discover, develop or commercialize drug candidates
under the collaboration. Regulatory authorities may determine to
delay or restrict Genentech's and/or Roche's ability to continue to
develop or commercialize Erivedge in BCC. Erivedge may not
demonstrate sufficient or any activity to merit its further
development in disease indications other than BCC. Competing drugs
may be developed that are superior to Erivedge. In connection with
its agreement with Oberland Capital, Curis faces risks relating to
the transfer and encumbrance of certain royalty and royalty-related
payments on commercial sales of Erivedge, including the risk that,
in the event of a default by Curis or its wholly-owned subsidiary,
Curis could lose all retained rights to future royalty and
royalty-related payments, Curis could be required to repurchase
such future royalty and royalty-related payments at a price that is
a multiple of the payments it has received, and its ability to
enter into future arrangements may be inhibited, all of which could
have a material adverse effect on its business, financial condition
and stock price. Curis will require substantial additional capital
to fund its business. If it is not able to obtain sufficient
funding, it will be forced to delay, reduce in scope or eliminate
some of its research and development programs, including related
clinical trials and operating expenses, potentially delaying the
time to market for, or preventing the marketing of, any of its
product candidates, which could adversely affect its business
prospects and its ability to continue operations, and would have a
negative impact on its financial condition and its ability to
pursue its business strategies. Curis faces substantial
competition. Curis and its collaborators face the risk of potential
adverse decisions made by the FDA and other regulatory authorities,
investigational review boards, and publication review bodies. Curis
may not obtain or maintain necessary patent protection and could
become involved in expensive and time-consuming patent litigation
and interference proceedings. Unstable market and economic
conditions, natural disasters, public health crises, political
crises and other events outside of Curis's control could
significantly disrupt its operations or the operations of third
parties on which Curis depends, and could adversely impact Curis's
operating results and its ability to raise capital. For example,
the COVID-19 pandemic may result in closures of third-party
facilities, impact enrollment in clinical trials or impact sales of
Erivedge by Genentech and/or Roche. The extent to which
the COVID-19 pandemic may impact Curis's business or operating
results is uncertain. Other important factors that may cause or
contribute to actual results being materially different from
those indicated by forward-looking statements include the factors
set forth under the captions "Risk Factor Summary" and "Risk
Factors" in our most recent Form 10-K and Form 10-Q, and the
factors that are discussed in other filings that we periodically
make with the Securities and Exchange Commission ("SEC"). In
addition, any forward-looking statements represent the views of
Curis only as of today and should not be relied upon as
representing Curis's views as of any subsequent date. Curis
disclaims any intention or obligation to update any of the
forward-looking statements after the date of this press release
whether as a result of new information, future events or otherwise,
except as may be required by law.
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SOURCE Curis, Inc.