LEXINGTON, Mass., Oct. 21, 2020 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
of innovative therapeutics for the treatment of cancer, today
highlighted a paper published online in ACS Medicinal Chemistry
Letters, a peer-reviewed publication of the American Chemical
Society, titled, "Discovery of CA-4948, an Orally Bioavailable
IRAK4 Inhibitor for Treatment of Hematologic Malignancies." The
paper describes the preclinical work done to select CA-4948 and its
on-target engagement and inhibition of IRAK4 in various animal
studies. CA-4948 demonstrated potent IRAK4 inhibition, with
favorable selectivity over other kinases, cellular activity,
pharmacokinetics, efficacy, and safety, and showed tumor regression
in a diffuse large B-cell lymphoma xenograft model without any
overt toxicities.
"We have been excited by the potential of CA-4948 since we began
our partnership with its initial developer, Aurigene, in 2015,"
said James Dentzer, President and
Chief Executive Officer of Curis. "This newly published paper
further validates our confidence in CA-4948's mechanism to
selectively inhibit IRAK4 and its potential as a treatment for
various hematologic malignancies. With our robust clinical
development program for CA-4948 currently in Phase 1, we look
forward to providing an update of clinical results for this program
later this quarter."
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' 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 CA-4948's
mechanism to selectively inhibit IRAK4 and its potential as a
treatment for various hematologic malignancies, and the Company's
expectations regarding its planned combination study of
CA-4948 and ibrutinib and the timeline for enrollment.
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.