LEXINGTON, Mass., Dec. 5, 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 that it
has entered into an investigator-initiated clinical trial agreement
with the University of Florida to study
the combination of emavusertib and pembrolizumab in patients with
metastatic melanoma.
- Curis is responsible for supply of emavusertib.
- Merck is responsible for supply of pembrolizumab and clinical
study costs.
- Both companies retain 100% of the commercial rights to their
respective programs.
This announcement builds on the preclinical findings recently
published for this combination by researchers at the University of Florida who, with the University of Chicago, will be the initial clinical
investigators for this study.
"We are pleased to advance the novel combination of emavusertib
(IRAK4) and pembrolizumab (anti-PD1) in metastatic melanoma," said
James Dentzer, President and CEO of
Curis. "We are grateful to Merck for their financial support of
this study and are excited to begin the exploration of
emavusertib's potential as an add-on to standard of care in solid
tumor malignancies."
The study, "A Phase 1/2 Study of Oral IRAK-4 Inhibitor CA-4948
in Combination With Pembrolizumab Following Stereotactic
Radiosurgery in Patients With Melanoma Brain Metastases"
(NCT05669352) is expected to begin enrollment in first half
2024.
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 investigator-initiated research agreement, the
potential developments and benefits of the combination of
emavusertib and pembrolizumab in metastatic melanoma, and the
potential of emavusertib as an add-on to standard of care in solid
tumor malignancies. 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 University of Florida may
experience delays and/or failures in initiating its combination
study of emavusertib and pembrolizumab, and Curis may experience
delays and/or failures in its supply of emavusertib. 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.