Curis working with clinical sites to resume
enrollment
Preliminary clinical data update
expected in 2023
LEXINGTON, Mass., Aug. 18,
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 lifted the partial
clinical hold on the TakeAim Lymphoma Phase 1/2 study of
emavusertib after reviewing the comprehensive data package
submitted by Curis.
"We are excited to announce that FDA has completed its review of
the TakeAim Lymphoma study and has lifted the partial clinical
hold. We are working with our clinical sites to quickly resume
enrollment of new patients in this study in the third quarter,"
said James Dentzer, President and
Chief Executive Officer of Curis.
Previously, Curis announced that the FDA had placed separate
partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma
studies on April 4 and April 11, 2022, respectively. The partial hold on
the TakeAim Leukemia study was issued by the FDA Division of
Hematologic Malignancies 1 (DHM1), which regulates clinical studies
in leukemia. The partial hold on the TakeAim Lymphoma study, and
the lifting of that hold, was issued by the FDA Division of
Hematologic Malignancies 2 (DHM2), which regulates clinical studies
in lymphoma. The partial clinical hold was lifted following
agreement with the FDA on Curis's strategy for rhabdomyolysis
identification and management, as well as on the enrollment of at
least nine additional patients at the 200 mg dose level of
emavusertib in combination with ibrutinib.
With the partial clinical hold lifted on the TakeAim Lymphoma
study, the Company is updating its timeline for clinical data
release to reflect the availability of updated preliminary data
from this study in 2023. In addition, Curis is proactively
discussing the clinical plans for emavusertib, including alignment
on optimal dose and development path, with DHM2 for the TakeAim
Lymphoma study.
About Emavusertib (CA-4948)
Emavusertib is an IRAK4 kinase inhibitor and 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. Additionally, third parties have
recently discovered that the long form of IRAK4 (IRAK4-L) is
oncogenic and preferentially expressed in over half of patients
with acute myeloid leukemia (AML) and myelodysplastic syndrome
(MDS). The overexpression of IRAK4-L is believed to be driven by a
variety of factors, including specific spliceosome mutations such
as SF3B1 and U2AF1. In addition to inhibiting IRAK4, emavusertib
was also designed to inhibit FLT3, a known oncologic driver, which
may provide additional benefit in patients with AML and MDS.
About TakeAim Leukemia
The TakeAim Leukemia study (NCT04278768) is a Phase 1/2
open-label dose escalation, dose expansion clinical trial
investigating emavusertib as a monotherapy and in combination with
azacitidine or venetoclax in patients with relapsed or refractory
(R/R) AML or high risk MDS. After dose escalation in both
monotherapy and combination therapy to determine the recommended
Phase 2 dose (RP2D), we plan to expand five cohorts: monotherapy in
AML patients with spliceosome and FLT3 mutations, monotherapy in
patients with MDS and spliceosome mutations and combination therapy
with azacitidine or venetoclax in patients without spliceosome or
FLT3 mutations. The goals of the study are to determine several
parameters including safety, maximum tolerated dose (MTD), RP2D and
signals of activity.
About TakeAim Lymphoma
The TakeAim Lymphoma study (NCT03328078) is a Phase 1/2
open-label, dose escalation, dose expansion clinical trial
investigating emavusertib as monotherapy and in combination with
ibrutinib in patients with R/R hematologic malignancies, such as
non-Hodgkin's lymphoma and other B cell malignancies. After dose
escalation in both monotherapy and combination therapy to determine
the RP2D, we plan to expand four cohorts for combination treatment:
marginal zone lymphoma, activated b-cell diffuse large b-cell
lymphoma, primary CNS lymphoma, and patients developing adaptive
resistance to ibrutinib monotherapy. The goals of the study are to
determine several parameters including safety, MTD, RP2D and
signals of activity.
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 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 trial in patients with AML and MDS,
for which it has received Orphan Drug Designation from the U.S.
Food and Drug Administration. The FDA has placed a partial clinical
hold on the TakeAim Leukemia trial during which no new patients
will be enrolled, and current study participants benefiting from
treatment may continue to be treated with emavusertib at doses of
300mg BID or lower. 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 with respect to
Curis's plans, strategies and objectives to resume and further
patient enrollment in its TakeAim Lymphoma trial and its ability to
resolve the partial clinical hold of the 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, Curis's plans and timelines to provide
preliminary, interim and/or additional data from its ongoing or
planned clinical trials, 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 not remove the partial clinical hold on the
Phase 1/2 TakeAim Leukemia trial or may take further regulatory
action with regard to such 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 develop or commercialize Erivedge in basal cell
carcinoma (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 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.