LEXINGTON, Mass., Oct. 7, 2021 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
of innovative therapeutics for the treatment of cancer, today
announced two poster presentations with new preclinical data for
CA-4948, a first-in-class small molecule IRAK4 inhibitor, at the
AACR-NCI-EORTC Virtual Conference on Molecular Targets and Cancer
Therapeutics.
"In ongoing Phase 1 clinical trials, CA-4948 has already
demonstrated anti-tumor activity in non-Hodgkin's lymphoma, acute
myeloid leukemia and myelodysplastic syndromes. New preclinical
data presented at AACR-NCI-EORTC today support the potential of
CA-4948 in additional hematologic cancers," said James Dentzer, President and Chief Executive
Officer of Curis.
"Notably, these new preclinical data indicate that CA-4948 is
synergistic with small molecules targeting BCR signaling, including
both idelalisib and ibrutinib, and suggest it may help overcome or
reduce secondary resistance to these therapies in marginal zone
lymphoma. In addition, these data demonstrate that CA-4948 can
cross the blood brain barrier and improve survival, in a
dose-dependent manner, providing additional preclinical support for
the study of CA-4948 in patients with primary central nervous
system (pCNS) lymphoma, one of the most aggressive forms of
lymphoma and a clear area of unmet need for patients." Mr. Dentzer
added.
Details of the presentations are as follows:
- Title: Pharmacological inhibition of IRAK-4 with CA-4948
is beneficial in marginal zone lymphoma models with secondary
resistance to PI3K and BTK inhibitors
- Author: Francesca Guidetti, Institute of Oncology
Research, Faculty of Biomedical Sciences, USI, Bellinzona,
Switzerland
- Poster Number: P073
- Title: The IRAK4 inhibitor CA-4948 demonstrates
antitumor activity in a preclinical model of CNS lymphoma
- Author: Christina A. von Roemeling, Ph.D., Research
Associate, UF Brain Tumor Immunotherapy Program, Department of
Neurosurgery, McKnight Brain Institute, University of Florida
- Poster Number: P243
Additional meeting information can be found on the AACR website
at:
https://www.aacr.org/meeting/aacr-nci-eortc-international-conference-on-molecular-targets-and-cancer-therapeutics/program/.
The presentations will also be available under "Posters and
Presentations" in the Pipeline: CA-4948 section of the Company's
website at www.curis.com
About CA-4948
CA-4948 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, CA-4948. CA-4948 is currently
undergoing testing in a Phase 1/2 trial in patients with
non-Hodgkin's lymphoma both as a monotherapy and in combination
with BTK inhibitor ibrutinib. Curis is also evaluating CA-4948 in a
Phase 1/2 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 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 will continue for their full terms, or
the CRADA with NCI, 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.
For further information:
Elif McDonald
VP, Investor Relations and Corporate Communications
Curis, Inc.
617-503-6583
emcdonald@curis.com
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SOURCE Curis, Inc.