LEXINGTON, Mass., May 12, 2021 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
of innovative therapeutics for the treatment of cancer, today
announced that two abstracts for CA-4948, a novel, small molecule
IRAK4 inhibitor, have been accepted for oral and poster
presentation at the European Hematology Association 2021 Virtual
Congress (EHA), which will be held virtually from June 9-17, 2021. The abstracts include updated
data from a February data-cut for its ongoing open-label, single
arm, Phase 1/2 study of CA-4948 in patients with acute myeloid
leukemia (AML) or high-risk myelodysplastic syndromes (MDS).
"We are very pleased to report this clinical update on our
first-in-class IRAK4 kinase inhibitor, CA-4948, as an anticancer
agent for patients with acute myeloid leukemia and
myelodysplastic syndromes for whom multiple prior lines of therapy
have been unsuccessful," said James
Dentzer, President and Chief Executive Officer of Curis.
"The clinical data published in the abstract this morning are
consistent with our preliminary findings reported late last year
showing that CA-4948 has, in addition to encouraging safety
characteristics, clear potential to reduce leukemic blasts in
late-line patients, along with early signs of hematologic recovery.
We look forward to providing updated safety, pharmacodynamic, and
efficacy data, as well as data from additional patients and
nonclinical combination synergy data at EHA next month."
Key findings from a cutoff date of February 8, 2021 in 15 patients (8 MDS and 7 AML)
include:
- Bone marrow blast reductions observed at all tested doses in 8
of 9 (89%) evaluable patients (at least one malignancy assessment
following first cycle) with elevated blast counts at baseline
- Objective responses observed included 1 patient experiencing a
full hematologic recovery complete response, 1 CRi with negative
minimal residual disease, and 2 bone marrow CRs
- All 3 patients with SF3B1 or U2AF1 spliceosome mutation
achieved marrow CR or better
- All patients with objective responses also saw signs of
hematologic recovery
Details of the presentations are as follows:
Oral Presentation:
- Title: A Phase 1, Dose Escalation Trial with Novel Oral
IRAK4 Inhibitor CA-4948 in Patients with Acute Myelogenous Leukemia
or Myelodysplastic Syndrome – Interim Report
- Author: Guillermo Garcia-Manero, MD, MD Anderson
Cancer Center
- Session Name: 10. Myelodysplastic syndromes -
Clinical
- Presentation Time: Friday, June
11, 2021, 09:00 CEST
(3:00 am ET)
- Q&A Session: Wednesday, June
16, 2021, 17:00 CEST
(11:00 am ET)
Poster Presentation
- Title: IRAK4 Inhibitor CA-4948 Potentiates
Antitumor Effects of Azacitidine and Venetoclax in Human Acute
Myeloid Leukemia
- Session Name: 01. Acute lymphoblastic leukemia –
Biology & Translational Research
- Session Date & Time: Friday, June 11, 2021,
09:00 CEST (3:00 am ET)
Virtual KOL Event
- Virtual event to be hosted Friday, June
11 at 8:00 am ET, featuring
Dr. Guillermo Garcia-Manero, Chief
of the Section of Myelodysplastic Syndromes within the Department
of Leukemia at The University of Texas
MD Anderson Cancer Center
- Discussion of the EHA presentation data from the ongoing Phase
1/2 study of CA-4948 in patients with acute myeloid leukemia and
myelodysplastic syndromes
- A live webcast of the presentation will be available under
"Events & Presentations" in the Investors section of the
Company's website at www.curis.com. A replay of the webcast
will be available on the Curis website for 90 days following the
event.
Additional meeting information can be found on the EHA website
at www.ehaweb.org/congress. Each presentation will also be
available under "Events and Presentations" in the Investors section
of the Company's website at www.curis.com
About CA-4948
CA-4948 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 AML and MDS. Third parties have
recently discovered that the long form of IRAK4 (IRAK4-L) is
oncogenic and preferentially expressed in over half of patients
with AML and 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.
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 1/2 in patients with non-Hodgkin's
lymphoma both as a monotherapy and in combination the with BTK
inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase
1/2 trial in patients with acute myeloid leukemia and
myelodysplastic syndromes, 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,
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' 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, any statements with respect to
Curis's plans, strategies, objectives or financial results;
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 activity, durability
and tolerability of CA-4948 and any key findings, and statements
with respect to 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, 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 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.