LEXINGTON, Mass., Dec. 11,
2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS),
a biotechnology company focused on the development of emavusertib
(CA-4948), an orally available, small molecule IRAK4 inhibitor,
last night presented clinical data from its TakeAim Leukemia Study
at the 2023 ASH Conference.
"We continue to be pleased with patient enrollment in the
TakeAim Leukemia study and are especially pleased that the data
confirm our observations to date – that emavusertib demonstrates a
safe and manageable safety profile in addition to clear anti-cancer
activity," said James Dentzer,
President and Chief Executive Officer of Curis.
Data were presented for 92 patients treated with emavusertib
monotherapy at doses ranging from 200 mg to 500 mg BID. Substantial
reductions in blast counts were observed across all patient groups,
irrespective of dose level, mutation status, or prior treatment
history. Treatment-related adverse events (TRAEs) of grade ≥ 3 were
found to be both manageable and acceptable, with no dose-limiting
myelosuppression detected.
In the targeted population of patients with a FLT3 mutation,
evidence of clear anti-cancer activity included changes in
mutational profiles that suggest disease-modifying activity. These
results were observed in patients including those who had
progressed on a prior FLT3 inhibitor.
Among relapsed/refractory patients with FLT3 mutation who
received ≤ 2 prior lines of treatment and had both baseline and
post-treatment marrow evaluations, administering 300 mg emavusertib
BID yielded compelling results. Notably, 2 out of 3 patients
achieved a Complete Response (CR) with the other achieving
morphological leukemia free state, indicating strong activity in
patients with FLT3 mutation.
About emavusertib (CA-4948)
Emavusertib is a small molecule IRAK4 inhibitor. IRAK4 plays an
essential role in the toll-like receptor (TLR) and interleukin-1
receptor (IL-1R) signaling pathways, which are frequently
dysregulated in patients with cancer. TLRs and the IL-1R family
signal through the adaptor protein MYD88, which results in the
assembly and activation of IRAK4, initiating a signaling cascade
that induces cytokine and survival factor expression mediated by
the NF-κB protein complex. Preclinical studies targeting IRAK1/4 in
combination with FLT3 have demonstrated the ability to overcome the
adaptive resistance incurred when targeting FLT3 alone. Further,
emavusertib has shown anti-tumor activity across a broad range of
hematologic malignancies including monotherapy activity in
patient-derived xenografts and synergy with both azacitidine and
venetoclax.
About TakeAim Leukemia Study
TakeAim Leukemia Study (NCT04278768) – study is open for
enrollment.
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 in patients with hematologic malignancies,
such as non-Hodgkin's lymphoma and other B cell malignancies in
combination with the BTK inhibitor ibrutinib, and as a monotherapy
in the Phase 1/2 TakeAim Leukemia study in patients with acute
myeloid leukemia and myelodysplastic syndrome, for which it has
received Orphan Drug Designation from the U.S. Food and Drug
Administration. 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, any statements with respect to
the TakeAim Leukemia study including the activity, safety,
tolerability, manageability and efficacy of emavusertib.
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. 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. 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. 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.
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SOURCE Curis, Inc.