LEXINGTON, Mass., April 4,
2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a
biotechnology company focused on the development of innovative
therapeutics for the treatment of cancer, today announced that the
U.S. Food and Drug Administration (FDA) has placed a partial
clinical hold on the Company's TakeAim Leukemia Phase 1/2a study
(NCT04278768). The TakeAim Leukemia study is a Phase 1/2a
open-label, single arm dose escalation and expansion study of
orally-administered emavusertib (CA-4948) as monotherapy and in
combination with azacitidine or venetoclax in patients with
relapsed or refractory (R/R) acute myeloid leukemia (AML) or
high-risk myelodysplastic syndrome (MDS).
While the partial hold is in place, no new patients will be
enrolled in the study, and current study participants benefitting
from treatment may continue to be treated with emavusertib at doses
of 300mg BID or lower.
With the partial hold, the FDA is requesting additional data
from the study, including data related to the death of a R/R AML
patient who experienced, among several conditions, rhabdomyolysis,
which has previously been identified as a dose-limiting toxicity of
emavusertib. Additionally, the FDA is requesting safety,
efficacy, and other data, including data related to rhabdomyolysis
and the Company's determination of the Recommended Phase 2 Dose for
emavusertib in this study.
"We are committed to ensuring the safety of patients in our
studies and to working collaboratively with the FDA to develop
therapies that meaningfully improve and extend patients' lives,"
said James Dentzer, Chief Executive
Officer of Curis. "Given the clinical profile of emavusertib
observed to date, we are hopeful that the study can be resumed
soon, after appropriate review. We continue to be confident in the
potential of emavusertib to address the high unmet need of patients
with AML or MDS."
Curis expects to provide updated guidance on the timing of
discussing the potential for a rapid registrational path for
emavusertib with the FDA after the partial clinical hold is
resolved and the related impact on the trial can be determined.
While this partial hold does not affect the TakeAim Lymphoma
study (NCT03328078), a Phase 1/2 open-label dose escalating
clinical trial investigating emavusertib in patients with B-cell
malignancies, the Company has decided to pause enrollment of new
patients in that study as well, pending resolution of the partial
clinical hold in the TakeAim Leukemia study.
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, emavusertib (CA-4948). Emavusertib is
currently undergoing testing in the Phase 1/2 TakeAim Lymphoma
trial, in patients with B-cell malignancies, both as a monotherapy
and in combination with BTK inhibitor ibrutinib. The FDA has placed
a partial clinical hold on Curis's evaluation of emavusertib in the
Phase 1/2 TakeAim Leukemia 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.
Cautionary Note Regarding
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
Curis's expectations regarding its interactions with the FDA, its
ability to resolve the partial clinical hold of the TakeAim
Leukemia study, and Curis's plans to advance its development
programs for emavusertib, including with respect to anticipated
results, clinical trials, regulatory plans and timelines; 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, the FDA may not remove the partial clinical hold on the
Phase 1/2 TakeAim Leukemia trial or may take further regulatory
action with regard to such trial; 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, or the
CRADA with NCI, 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 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 the factors that are discussed in other
filings that we periodically make with the Securities and Exchange
Commission. 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.