LEXINGTON, Mass., Nov. 10, 2020 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
of innovative therapeutics for the treatment of cancer, today
announced that it has entered into a Cooperative Research and
Development Agreement (CRADA) with the National Cancer Institute
(NCI), a component of the National Institutes of Health, for joint
development of CA-4948, a first-in-class small molecule IRAK4
kinase inhibitor, as an anti-cancer agent under the NCI
Experimental Therapeutics Program (NExT).
Under the CRADA, Curis will collaborate with the NCI Cancer
Therapy Evaluation Program to conduct non-clinical and clinical
studies of Curis's proprietary compound CA-4948, an IRAK-4 kinase
inhibitor that acts as a Toll-like Receptor (TLR) suppressor, as an
anti-cancer agent.
"In addition to expanding the reach of this important clinical
program, we believe this CRADA will provide powerful validation of
our target-specific approach to developing impactful novel
therapeutics for patients suffering from devastating cancers," said
James Dentzer, President and Chief
Executive Officer of Curis. We look forward to working closely
alongside the team at the NCI and utilizing their tremendous
expertise and resources as we advance CA-4948 through the clinical
process."
About CA-4948
CA-4948 is a small molecule inhibitor of IRAK4, which is
currently being tested in a Phase 1 dose escalating clinical trial
in patients with non-Hodgkin lymphomas, including those with
Myeloid Differentiation Primary Response 88 ("MYD88"), alterations.
CA-4948 is also being investigated in a separate Phase 1 trial for
acute myeloid leukemia and myelodysplastic syndromes. The Company
is planning a combination study of CA-4948 and ibrutinib, a BTK
inhibitor, in non-Hodgkin lymphomas with planned enrollment
commencing in the fourth quarter of 2020.
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 trial in patients with non-Hodgkin
lymphoma and in a Phase 1 trial in patients with acute myeloid
leukemia and myelodysplastic syndromes. 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 1a/1b
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, statements regarding the
potential developments and benefits of CA-4948 under the
CRADA, the Company's plans to work with the NCI to advance
CA-4948, and the Company's expectations regarding NCI's
expertise and resources, and the validation of the Company's
target-specific approach to developing impactful novel
therapeutics. Forward-looking statements may contain the words
"believes," "expects," "anticipates," "plans," "intends," "seeks,"
"estimates," "assumes," "will," "may," "could" 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, 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. Based on its available cash resources, it
does not have sufficient cash on hand to support current operations
within the next 12 months from the date of this press release. 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. If it is unable to continue as a going concern, it may
have to liquidate its assets and may receive less than the value at
which those assets are carried on its audited financial statements,
and it is likely that investors will lose all or a part of their
investment. Curis faces substantial competition. Curis also
faces risks relating to 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 Curis's ongoing or
planned 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. 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
caption "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.