Initial TakeAim Lymphoma combination data
shows anti-cancer activity, including 1 complete response and 2
partial responses, in heavily pretreated patients including those
with prior ibrutinib use
LEXINGTON, Mass., May 12, 2022
/PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company
focused on the development of innovative therapeutics for the
treatment of cancer, today announced that multiple abstracts have
been accepted for presentation at the upcoming European Hematology
Association 2022 Hybrid Congress (EHA), which will be held
virtually and in-person in Vienna
on June 9-12, 2022. The abstracts
include data from both the TakeAim Leukemia and TakeAim Lymphoma
studies as well as other studies by Curis and independent
collaborators. These planned presentations are in addition to the
previously announced presentations scheduled for the upcoming 2022
American Society of Clinical Oncology (ASCO) Annual Meeting taking
place in Chicago and online
June 3-7, 2022.
"We are pleased that research from our lead programs will be
shared with the oncology community at ASCO and EHA this year," said
James Dentzer, Chief Executive
Officer of Curis. "We are excited to share the initial data from
the TakeAim Lymphoma study investigating the use of emavusertib in
combination with ibrutinib in patients with several types of
Non-Hodgkin's Lymphoma. Data in the abstract indicates that the
combination has shown signs of early anti-cancer activity,
including in patients with prior BTK inhibitor use, and the regimen
appears to be well tolerated. The data from the TakeAim Leukemia
study are consistent with our findings reported in January of this
year, demonstrating emavusertib's encouraging monotherapy activity
in patients with R/R AML and MDS including importantly those with
spliceosome and FLT3 mutations. Currently the prognosis for
patients with R/R AML or MDS is grim, there are no effective
therapies and new options are very much needed. In addition to data
from Curis, there will be several interesting data sets from
Curis's collaborators. We look forward to providing further updates
at EHA and ASCO next month."
Both of the TakeAim studies are to be presented at both the ASCO
and EHA meetings. In addition, at EHA Curis will present data on
the development of potential biomarkers for emavusertib in AML.
Finally, Curis's collaborators will present data at EHA on the use
of emavusertib in primary CNS lymphoma.
Details of the EHA presentations are as follows:
Abstract Title: TakeAim Lymphoma- An Open-Label, Dose
Escalation And Expansion Trial Of Emavusertib (CA-4948) In
Combination With Ibrutinib In Patients With Relapsed Or Refractory
Hematologic Malignancies
Presenting Author: Grzegorz Nowakowski, MD, Mayo
Clinic Rochester
Abstract Code: P1121
Session Type/Title: Poster Session
Date and Time: June 10, 2022,
4:30 – 5:45 pm CEST
Abstract Title: TakeAim Leukemia A Phase 1/2a Study Of
The IRAK4 Inhibitor Emavusertib (CA-4948) As Monotherapy Or In
Combination With Azacitidine Or Venetoclax In Relapsed/Refractory
AML Or MDS
Presenting Author: Guillermo Garcia-Manero, MD, MD
Anderson Cancer Center
Abstract Code: S129
Session Type/Title: Novel insights into AML
treatment
Session Room: Hall A7
Date and Time: June 11,
2022, 4:30 – 5:45 pm
CEST
Abstract Title: Development of Potential Biomarkers
for IRAK4 Inhibitor Emavusertib in Human Acute Myeloid Leukemia
Presenting Author: Andrey Ugolkov, PhD
Abstract Code: P473
Session Title: Poster session
Date and Time: Friday, June 10, 2022 - 4:30 - 5:45 pm CEST
Collaborator Presentations
Abstract Title: The IRAK-4 Inhibitor Emavusertib
(CA-4948) For The Treatment Of Primary CNS Lymphoma
Presenting Author: Christina Von Roemeling, PhD The
University of
Florida
Abstract Code: P1298
Session Type/Title: Poster Session
Date and Time: June 10,
2022, 4:30 – 5:45 pm
CEST
The abstracts are available online at ehaweb.org/.
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-Hodgkins 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 acute myeloid leukemia and myelodysplastic
syndrome, 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 and TakeAim Lymphoma trials
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, 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 initiation, progression,
expansion, use, efficacy, dosage and potential benefits of CA-4948
in clinical trials as a monotherapy and/or as a combination
therapy, the progression, use and potential benefits of CI-8993,
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 or its ability to resolve the partial
clinical hold of the TakeAim Leukemia study or the partial clinical
hold of the TakeAim Lymphoma study, and 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 the
partial clinical hold on the Phase 1/2 TakeAim Lymphoma 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
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/curis-announces-abstracts-accepted-for-presentation-at-the-european-hematology-association-2022-congress-eha-301546222.html
SOURCE Curis, Inc.