LEXINGTON, Mass., July 7, 2020 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
of innovative therapeutics for the treatment of cancer, today
announced that the first patient has been dosed in its Phase 1
trial evaluating CA-4948, a novel, small molecule IRAK4 kinase
inhibitor, in patients with acute myeloid leukemia (AML) or
high-risk myelodysplastic syndromes (MDS) with spliceosome
mutations, such as SF3B1 and U2AF1, that drive expression of the
long isoform of IRAK4 (IRAK4-L). IRAK4 plays an essential role in
the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R)
signaling pathways, and these pathways are frequently dysregulated
in patients with AML and MDS.
"When Drs. Daniel Starczynowski,
Professor, Cincinnati Children's Hospital and Amit Verma, Director of the Division of
Hematologic Malignancies at the Albert Einstein College of
Medicine, demonstrated the important pathogenic role of IRAK4 in
MDS/AML in their seminal publication in Nature Cell Biology and
presentation at ASH last December, everyone in the AML/MDS
community paid attention, including our team at Curis," said
James Dentzer, President and Chief
Executive Officer of Curis. "Dr. Starczynowski, Dr. Verma, and
their colleagues showed that IRAK4-L, the oncogenic long isoform of
IRAK-4, is expressed as a result of specific spliceosome mutations
common in AML and MDS. Further, they demonstrated that it
potentially impacts over 50% of the AML/MDS population. We quickly
worked with our clinical investigators and the U.S. Food and Drug
Administration (FDA) to design a study of CA-4948, our
first-in-class IRAK4 inhibitor, in this population. We are pleased
to announce today, just six months later, that we have initiated
this new study and successfully dosed our first patient. The
initial dose in this study is 200mg twice-daily (BID) which, based
on our preclinical models, we believe may be a therapeutic dose
level. As a result, we expect to report initial efficacy data by
the end of the year."
"Historically, no single oncogenic driver of AML and MDS has
been known to impact the majority of patients," said Dr.
Guillermo Garcia-Manero, Chief,
Section of Myelodysplastic Syndromes at the University of Texas MD Anderson Cancer Center.
"Recent studies have changed this understanding. The long isoform
of IRAK4, itself the result of specific genetic mutations, was
recently discovered to be a driver of disease in over half the
population of patients with AML and MDS. With CA-4948, we may now
have a single drug that can directly target a key driver of disease
in these patients. We are delighted to be a lead clinical site in
the study of this novel new drug."
About the CA-4948 Phase 1 Clinical Trial
The Phase 1 trial is an open-label, dose escalation study
designed to evaluate the safety, pharmacokinetics, pharmacodynamics
and clinical activity of CA-4948 in patients with AML and high-risk
MDS. The primary objective of the study is to determine the maximum
tolerated dose and recommended Phase 2 dose of CA-4948 based on
safety and tolerability, dose-limiting toxicities (DLTs), and
pharmacokinetic and pharmacodynamic findings. A minimum of three
patients will be enrolled at each dose level, starting with 200 mg
BID, which was determined to be safe, capable of achieving relevant
levels of drug exposure, and demonstrated signs of biologic
activity and clinical efficacy in a separate, ongoing Phase 1
study. Each treatment cycle will be 28 days in length and repeated
in the absence of toxicity. Initial data from the study is expected
in the fourth quarter of 2020.
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, CA-4948. CA-4948 is currently
undergoing testing in a Phase 1 trial in patients with non-Hodgkin
lymphoma and in a Phase 1 trial in patients with acute myeloid
leukemia and myelodysplastic syndromes. 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' website at www.curis.com.
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, statements regarding the
potential advantages and benefits of CA-4948 to treat patients
with acute myeloid leukemia (AML) and/or with myeloid
malignancies and certain spliceosome mutations, the Company's
plans to report initial efficacy data in the fourth quarter of
2020, and the Company's expectations regarding the potential
therapeutic benefit of CA-4948. Forward-looking statements may
contain the words "believes," "expects," "anticipates," "plans,"
"intends," "seeks," "estimates," "assumes," "will," "may," "could"
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, 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' 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' 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, 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 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. Based on its available cash resources, it
does not have sufficient cash on hand to support current operations
within the next 12 months from the date of this press release. 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. If it is unable to continue as a going concern, it may
have to liquidate its assets and may receive less than the value at
which those assets are carried on its audited financial statements,
and it is likely that investors will lose all or a part of their
investment. Curis faces substantial competition. Curis also
faces risks relating to 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'
control could significantly disrupt its operations or the
operations of third parties on which Curis depends, and could
adversely impact Curis' 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 Curis' ongoing or
planned clinical trials or impact sales of Erivedge by
Genentech and/or Roche. The extent to which the COVID-19
pandemic may impact Curis' business or operating results is
uncertain. 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
caption "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' 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.