LEXINGTON, Mass., April 19, 2021 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
of innovative therapeutics for the treatment of cancer, is pleased
to announce that the U.S. Food and Drug Administration (FDA) has
granted Orphan Drug designation for CA-4948, a first-in-class,
small molecule inhibitor of IRAK4 and Curis's most advanced
therapeutic in clinical development. CA-4948 targets IRAK4-L, the
oncogenic isoform of IRAK4 preferentially expressed by the majority
of patients with acute myeloid leukemia (AML) and myelodysplastic
syndromes (MDS) and has shown broad clinical activity in Phase 1
trials in patients with relapsed or refractory (R/R) AML/MDS.
"We are pleased to take this important next step in unlocking
the potential of CA-4948 to offer a safe and transformative,
disease-modifying alternative treatment for patients on the AML/MDS
spectrum," said James Dentzer, chief
executive officer of Curis. "Receiving Orphan Drug designation for
CA-4948 in AML and MDS represents a significant milestone in our
mission of slowing or preventing the progression of disease in
patients with these rare hematological malignancies."
Orphan Drug Designation is granted by the FDA to drugs intended
to treat rare disorders that affect fewer than 200,000 people in
the U.S. The designation can provide development and commercial
incentives, including eligibility for seven years of market
exclusivity in the U.S. after product approval, FDA assistance in
clinical trial design and exemption from FDA user fees.
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 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
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 any
expectations of the potential benefits of CA-4948, including its
safety, tolerability and/or ability to modify, slow or prevent
disease progression; and the potential benefits of having received
orphan drug designation for CA-4948. 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. 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 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 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 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.