LEXINGTON, Mass., Dec. 10,
2024 /PRNewswire/ -- Curis, Inc. ("Curis") (NASDAQ:
CRIS), a biotechnology company focused on the development of
emavusertib (CA-4948), an orally available, small molecule IRAK4
inhibitor, yesterday presented data from the TakeAim Leukemia study
(CA-4948-102) in relapsed/refractory (R/R) Acute Myeloid Leukemia
(AML) at the 66th ASH annual meeting.
The additional data presented include data for 21 patients with
a FLT3 mutation (FLT3m) who had received fewer than 3 lines of
prior therapy and were treated with emavusertib as monotherapy at
the Recommended Phase 2 Dose (RP2D) of 300 mg BID. This brings the
total number of patients dosed at the RP2D from 12 to 21
patients.
Data show 10 objective responses in 19 response-evaluable
patients: 6 complete remission (CR), 2 CR with either a complete
remission with incomplete hematological recovery (CRi) or a partial
hematological recovery (CRh) and 2 morphologic leukemia-free state
(MLFS). Prior therapies of responders included Venetoclax (5/10),
HMA (6/10), and FLT3i (6/10). Two of the 21 patients were treated,
but discontinued treatment prior to first disease assessment (death
occurred at Day 8 and Day 13, respectively), and were not included
as response-evaluable patients.
Two patients who achieved a CR and CRi, respectively, proceeded
to allogenic stem cell transplantation. Responses were achieved
rapidly in this population, with 7 of 10 responses reported at
the first assessment (Cycle 2 Day 1).
"We continue to be pleased with the monotherapy data in R/R AML
patients with a FLT3 mutation," said James
Dentzer, President and CEO of Curis, "and believe these data
further support the exciting potential of emavusertib's novel
mechanism to address a significant unmet need in patients with
AML."
About Curis, Inc.
Curis is a biotechnology company focused on the development of
emavusertib, an orally available, small molecule IRAK4 inhibitor.
Emavusertib is currently undergoing testing in the Phase 1/2
TakeAim Lymphoma study (CA-4948-101) in patients with
relapsed/refractory primary central nervous system lymphoma (PCNSL)
in combination with the BTK inhibitor ibrutinib, as a monotherapy
in the Phase 1/2 TakeAim Leukemia study (CA-4948-102) in patients
with relapsed/refractory acute myeloid leukemia (AML) and
relapsed/refractory high risk myelodysplastic syndrome (hrMDS) with
either a FLT3 mutation or a splicing factor mutation (U2AF1 or
SF3B2), and as a frontline combination therapy with azacitidine and
venetoclax in patents with AML (CA-4948-104). Emavusertib has
received Orphan Drug Designation from the U.S. Food and Drug
Administration for the treatment of AML and MDS and from the
European Commission for the treatment of PCNSL. Curis, through
its 2015 collaboration with Aurigene, has the exclusive license to
emavusertib (CA-4948). Curis licensed its rights to Erivedge® to
Genentech, a member of the Roche Group, under which they 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, statements regarding
additional data from the TakeAim Leukemia study and the therapeutic
potential of emavusertib in patients with AML; statements
concerning research, development, clinical trials and
commercialization plans, timelines, anticipated results or the
therapeutic potential of emavusertib including the progression,
expansion, use, safety, efficacy, rates and duration of responses,
mutations or potential biomarkers, and potential benefits of
emavusertib in clinical trials as a monotherapy and/or as a
combination therapy; 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. 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. Curis is
dependent on the success of emavusertib and any delays in the
development of emavusertib could have a material adverse effect on
its business. There can be no guarantee that the collaboration
agreement with Aurigene will continue for its full term, or the
CRADA with NCI, 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 commercialize Erivedge in basal cell
carcinoma. 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
the development emavusertib, including related clinical trials and
operating expenses, potentially delaying the time to market for, or
preventing the marketing of, emavusertib, 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. 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 Form 10-Q, 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/curis-announces-additional-data-from-takeaim-leukemia-study-302326938.html
SOURCE Curis, Inc.