LEXINGTON, Mass., July 6, 2023
/PRNewswire/ -- Curis, Inc., (Nasdaq: CRIS), a biotechnology
company focused on the development of emavusertib, an orally
available small molecule triple target inhibitor (IRAK4, FLT3 and
CLK) for the treatment of hematologic malignancies, today announced
that the U.S. Food and Drug Administration (FDA) has removed the
partial clinical hold on the TakeAim Leukemia Phase 1/2 study of
emavusertib. Further, the recommended phase 2 dose (RP2D) for
emavusertib as a monotherapy has been established at 300 mg BID in
patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic
Syndromes (MDS).
"We are pleased to announce that FDA has removed the partial
clinical hold on the TakeAim Leukemia study and that we are
proceeding with 300 mg BID as our RP2D. We are working with our
clinical sites to enroll targeted patients with AML (patients with
a FLT3 or spliceosome mutation who have received ≤ 2 prior lines of
treatment). We also plan to initiate a front-line combination study
of emavusertib with azacitidine and venetoclax. We believe
emavusertib has the potential to be the cornerstone agent in the
treatment of hematological malignancies." said James Dentzer, President and Chief Executive
Officer of Curis. "In 2024, we expect to have updated data from the
TakeAim Leukemia monotherapy study, clarification of a monotherapy
registrational study design, and initial data from an azacitidine
and venetoclax combination study."
On April 4, 2022, the Company
announced that the FDA placed a partial clinical hold on the
TakeAim Leukemia study. On August 30,
2022, the Company announced that the FDA notified Curis that
it may resume enrollment of additional patients in the monotherapy
dose finding phase of the TakeAim Leukemia study, so that the
Company could enroll at least nine additional patients at the 200
mg BID dose level. On July 6, 2023,
the Company announced the FDA had removed the partial clinical hold
on the TakeAim Leukemia study and that the RP2D has been
established at 300 mg BID.
In the TakeAim Leukemia study, as of the March 17, 2023 data cutoff for patients dosed
prior to February 9, 2023, 84
patients received emavusertib monotherapy, ranging from doses of
200 mg to 500 mg BID. Significant blast count reductions have been
observed across all patient groups, regardless of dose level,
mutation status, or number of prior lines of treatment. Emerging
from these data are two genetically-defined subpopulations of
relapsed/refractory (R/R) patients who have demonstrated compelling
responses in monotherapy: AML patients with FLT3 mutation and AML
patients with spliceosome mutation (U2AF1 or SF3B1 mutation) who
have received ≤ 2 prior lines of treatment. In these subpopulations
of evaluable patients (patients whose disease has been determined
to be evaluable for objective response with baseline and
post-treatment marrow assessments) treated with 300 mg BID, 2 of 3
patients with a FLT3 mutation achieved a CR (Complete Response),
and 2 of 3 patients with spliceosome mutation achieved a CR or CRh
(Complete Response with Partial Hematologic Recovery). The duration
of response for these patients ranged from 5.6 to 7.0 months.
"A significant unmet need remains for patients with AML and MDS
with the majority of front-line patients relapsing with currently
available treatment options," said Dr. Reinhard von Roemeling, Senior Vice President of
Clinical Development of Curis. "Emavusertib has the potential to be
uniquely positioned as an addition to frontline therapy in
combination with standard of care and also as a monotherapy in
targeted R/R patient populations."
About emavusertib (CA-4948)
Emavusertib is a triple target inhibitor (IRAK4, FLT3 and
CLK). 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 Studies
TakeAim Leukemia Study (NCT04278768) – study is open for
enrollment.
TakeAim Lymphoma Study (NCT03328078) – study is open for
enrollment.
About Curis, Inc.
Curis is a biotechnology company focused development of
emavusertib, a triple target inhibitor (IRAK4, FLT3 and CLK) for
the treatment of hematologic malignancies. 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 study in patients with
hematologic malignancies, such as non-Hodgkin's lymphoma and other
B cell malignancies, both as a monotherapy and in combination with
BTK inhibitor ibrutinib, and 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. In addition, Curis is
engaged in a collaboration with ImmuNext for development of
CI-8993, a monoclonal anti-VISTA antibody. 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 with respect to
Curis's plans, strategies and objectives to resume and further
patient enrollment in its TakeAim Leukemia study, initiate a
front-line combination study of emavusertib with azacitidine and
venetoclax, and provide updated data from such studies and
clarification of a monotherapy registrational study design for its
TakeAim Leukemia study, statements concerning product research,
development, clinical trials and studies and commercialization
plans, timelines, anticipated results or the therapeutic potential
of drug candidates including any statements regarding the
initiation, progression, expansion, use, safety, efficacy, dosage
and potential benefits of emavusertib in clinical trials as a
monotherapy and/or as a combination therapy, the progression, use
and potential benefits of CI-8993, Curis's plans and timelines to
provide preliminary, interim and/or additional data from its
ongoing or planned clinical trials, its ability to further patient
enrollment in its TakeAim Leukemia and TakeAim Lymphoma studies,
any statements concerning Curis's expectations regarding its
interactions with the FDA, statements with respect to mutations or
potential biomarkers, 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 take further regulatory action with regard to
Curis's clinical trials. 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, 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.