LEXINGTON, Mass., Feb. 2, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ:
CRIS), a biotechnology company focused on the development of
innovative therapeutics for the treatment of cancer, today
announced the initiation of a Phase 2 investigator-sponsored trial
(IST) evaluating CA-4948, a novel, small molecule IRAK4 kinase
inhibitor, for the treatment of anemia in patients with very low,
low, or intermediate-risk myelodysplastic syndromes (MDS). The
study is being led by Uwe
Platzbecker, M.D., Ph.D., Professor and Director of the
Medical Clinic and Polyclinic for Hematology, Cell Therapy, and
Hemostaseology at the University Hospital in Leipzig. Dr. Platzbecker is co-founder and
chairman of both the European Myelodysplastic Syndromes Cooperative
Group (EMSCO) and the German MDS Study Group (D-MDS). Furthermore,
he acts as co-chairman of the European Hematology Association's
Scientific Working Group on MDS.
"Following the very promising preliminary data we presented in
December in patients with relapsed/refractory AML and high-risk
MDS, we are eager to further explore if CA-4948 may also provide
benefit in other indications, including in MDS patients with lower
risk profiles. To that end, we are excited to collaborate with Dr.
Platzbecker, a renowned MDS clinician," said James Dentzer, President and Chief Executive
Officer of Curis. "This IST, along with the previously announced
CRADA with the NCI, will enable us to leverage the resources of
large, highly regarded institutions as we continue to advance and
broaden our IRAK4 clinical program."
"As we have learned through intensified surveillance strategies
for asymptomatic lower-risk MDS, there is a distinct need for safe
treatments to modify the natural history of early MDS before it
progresses to AML. These patients often have higher genetic risk
prognoses, worsening cytopenia, an increase in the number of
circulating or bone marrow blasts, and signs of cytogenetic
evolution," said Dr. Platzbecker, the lead investigator on the
LUCAS study. "Current therapies that target anemia in genetically
defined lower-risk MDS with erythropoiesis stimulating agents are
effective, but transient, often ending in progression and disease
complications. As a direct, non-myelosuppressive target of IRAK4,
CA-4948 may possess safe disease-modifying potential in lower-risk
MDS that can slow or prevent further progression."
About the Phase 2 LUCAS Trial
The LUCAS study is a Simon 2-stage Phase 2, open-label,
multicenter trial evaluating the safety and efficacy of CA-4948
monotherapy for the treatment of anemia in patients with very low,
low, or intermediate risk MDS. The trial is expected to start
recruitment in the second quarter of 2021 at 17 sites of the D-MDS
and is designed to enroll 84 patients across two cohorts consisting
of 42 patients each. Cohort A will include erythropoiesis
stimulating agent (ESA) refractory/intolerant patients and Cohort B
will include ESA naïve patients with transfusion dependence (min.
20 patients) or transfusion independence (min. 20 patients).
Patients in both cohorts will receive 300mg CA-4948 twice-daily
(BID) for 21 days in at least four repeating cycles lasting 28 days
each. The primary endpoint of the study is to evaluate the
proportion of patients that develop an erythroid response (HI-E)
according to IWG 2018 criteria. Secondary and exploratory endpoints
of the study include: broader anti-cancer activity, safety &
toxicity, and predictive biomarkers. An interim analysis for
futility will be conducted after 21 patients have completed the
designated treatment period in either cohort.
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's 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 any
expectations of the potential for the Company's proprietary drug
candidate CA-4948, including the potential developments and
benefits of CA-4948 under the investigator-sponsored LUCAS
study, and any statements with respect to the LUCAS study, the
CRADA with NCI, and the Company's ability to advance and broaden
its clinical programs. 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.