LEXINGTON, Mass., Dec. 12,
2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a
biotechnology company focused on the development of emavusertib
(CA-4948), an orally available, small molecule IRAK4 inhibitor,
today announced initial combination study data from its TakeAim
Lymphoma trial including 5 primary CNS lymphoma (PCNSL)
patients.
"We are very pleased with the initial emavusertib/ibrutinib
combination data from the TakeAim Lymphoma study. We are
particularly excited about the activity in relapsed/refractory
PCNSL and the meaningful benefit emavusertib may provide in
combination with BTKi," said James
Dentzer, President and Chief Executive Officer of Curis.
As of October 12th, the TakeAim
Lymphoma trial has enrolled and treated 19 Non-Hodgkin Lymphoma
(NHL) patients, with a combination of emavusertib and ibrutinib;
with emavusertib doses ranging from 100 mg to 300 mg BID. The
initial data reveal encouraging efficacy, demonstrating multiple
objective responses in both BTK-naïve and BTK-experienced
patients.
Patients with PCNSL who had a history of failed BTKi therapy
showed a particularly noteworthy response: 3 out of 5 evaluable
PCNSL patients achieved a Complete Response (CR), with durability
ranging from 0.3 – 8.9 months. These data underscore the potential
of emavusertib to re-sensitize patients to BTKi therapy, marking a
significant advancement in Non-Hodgkin Lymphoma treatment.
Consistent with our previous findings, the emavusertib/ibrutinib
combination demonstrates a manageable and acceptable safety
profile, with no observed dose-limiting toxicities (DLTs) in the
200 mg cohort and 2 reversible DLTs (stomatitis and syncope) in the
300 mg cohort.
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 Lymphoma Study
TakeAim Lymphoma Study (NCT03328078) – 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 Lymphoma study including the potential
developments and benefits of emavusertib in combination with
ibrutinib in relapsed/refractory primary CNS lymphoma (PCNSL)
and/or the potential benefits in combination with BTKi, and 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.