Schr�dinger (Nasdaq: SDGR), whose physics-based computational
platform is transforming the way therapeutics and materials are
discovered, today announced new preclinical data on SGR-1505, its
investigational MALT1 inhibitor, and SGR-2921, its investigational
CDC7 inhibitor, in a poster session at the American Society of
Hematology (ASH) 65th Annual Meeting taking place virtually and in
San Diego, California. The preclinical data reported show that both
SGR-1505 and SGR-2921 have multiple favorable attributes and the
potential for combination activity with standard-of-care
agents.
Schr�dinger also reported preliminary pharmacodynamic data from
the Phase 1 study of SGR-1505 in healthy subjects, which showed
that SGR-1505 inhibited cytokine release in human whole blood and
demonstrated evidence of MALT1 inhibition in humans. The company
will report additional data from the healthy subject study at its
Pipeline Day on December 14, 2023.
“The pharmacological data for SGR-1505 and SGR-2921 demonstrate
that our development candidates have favorable, differentiated
profiles with best-in-class potential,” stated Karen Akinsanya,
Ph.D., president of R&D therapeutics at Schr�dinger. “Our
progress within these programs further validates our computational
approach to designing therapies with the potential to address the
limitations of current treatments. SGR-1505 and SGR-2921 are now
being evaluated in Phase 1 clinical studies, and we look forward to
seeing these programs advance.”
A Phase 1 dose-escalation study of SGR-1505 in relapsed or
refractory B-cell malignancy patients is ongoing in the U.S. and
Europe. Additionally, a Phase 1 clinical study of SGR-2921 was
recently initiated in patients with acute myeloid leukemia or
myelodysplastic syndrome. Both studies are designed to evaluate the
safety, pharmacokinetics, pharmacodynamics, and determine the
recommended dose for further development.
SGR-1505 Data at ASH
The presentation (Abstract # 2997), “SGR-1505 is a Potent MALT1
Protease Inhibitor with a Potential Best-in-Class Profile,”
includes preclinical data demonstrating the potency of SGR-1505 and
the potential for combination activity with standard of care
agents. Preclinical data showed that SGR-1505 is more potent than
JNJ-6633, which has previously provided clinical validation for
MALT1 inhibition as a potential therapeutic strategy for treating
both chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas
(NHL). In a preclinical model of diffuse large B-cell lymphoma,
SGR-1505, in combination with venetoclax, demonstrated a stronger
combination impact on cell viability compared to JNJ-633 plus
venetoclax. Gene expression analysis showed that SGR-1505 provides
greater modulation of NF-ΚΒ and related pathway genes compared to
JNJ-6633. Signaling of the NF-ΚΒ pathway is known to play a
critical role in the initiation and progression of many types of
cancers, particularly B cell malignancies.
Preliminary clinical biomarker data from the Phase 1 study in
healthy subjects showed that SGR-1505 inhibited cytokine release in
ex vivo stimulation of human whole blood. The inhibition of certain
cytokines in whole blood from human subjects dosed with SGR-1505
provides pharmacodynamic evidence of MALT1 inhibition. These data
are consistent with prior preclinical observations in an in vitro
whole blood assay from healthy human subjects, where approximately
a 50-fold lower concentration of SGR-1505 was needed to achieve 90
percent inhibition of cytokine release compared to JNJ-6633. The
data support continued evaluation of SGR-1505 in the ongoing Phase
1 study in patients with advanced B-cell malignancies.
SGR-2921 Data at ASH
The presentation (Abstract #2801), “SGR-2921, a Potent CDC7
Inhibitor, Demonstrates Significant Anti-Leukemic Responses in
Patient-Derived AML Models Representing Difficult-to-Treat
Disease,” includes preclinical data for SGR-2921 which demonstrate
the potency, breadth of activity and synergistic effects of
SGR-2921 in combination with standard-of-care therapies. In vitro,
SGR-2921 exhibited greater potency compared to other clinical-stage
CDC7 inhibitors and showed anti-proliferative activity in AML
patient-derived samples regardless of driver mutations. In vivo,
SGR-2921 showed dose-dependent reduction of AML blasts in multiple
AML models representing difficult-to-treat disease. SGR-2921 also
showed synergistic activity in combination with decitabine in
p53-mutated AML models in vivo. Together, these data support the
ongoing evaluation of SGR-2921 as a potential treatment for AML,
with particular utility in patients with high-risk mutations and
relapsed and refractory AML.
Schr�dinger Pipeline Day Webcast Information
Schr�dinger will review the company's proprietary research and
development programs, including updates on SGR-1505 and SGR-2921,
at its Pipeline Day taking place in-person and virtually on
December 14, 2023. Pipeline Day will be a hybrid event, with a
webcast and limited in-person attendance available to members of
the investment community. The presentation can be accessed in the
“Investors” section of Schr�dinger’s website and will be archived
for approximately 90 days. To participate in the live webcast,
please register for the event here. It is recommended that
participants register at least 15 minutes in advance of the
event.
About Schr�dinger
Schr�dinger is transforming the way therapeutics and materials
are discovered. Schr�dinger has pioneered a physics-based
computational platform that enables discovery of high-quality,
novel molecules for drug development and materials applications
more rapidly and at lower cost compared to traditional methods. The
software platform is licensed by biopharmaceutical and industrial
companies, academic institutions, and government laboratories
around the world. Schr�dinger’s multidisciplinary drug discovery
team also leverages the software platform to advance a portfolio of
collaborative and proprietary programs to address unmet medical
needs.
Founded in 1990, Schr�dinger has approximately 800 employees and
is engaged with customers and collaborators in more than 70
countries. To learn more, visit www.schrodinger.com, follow us on
LinkedIn and Instagram, or visit our blog, Extrapolations.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of 1995
including, but not limited to those statements regarding the
potential advantages of Schr�dinger’s computational platform, the
clinical potential and favorable properties of its product
candidates, including SGR-1505 and SGR-2921, the potential for
SGR-1505 to be used for the treatment of advanced B-cell
malignancies, the potential for SGR-2921 to be used for the
treatment of AML or myelodysplastic syndrome, and the timing,
progress, and results of clinical trials for its product
candidates. Statements including words such as “aim,” “anticipate,”
“believe,” “contemplate,” “continue,” “could,” “estimate,”
“expect,” “goal,” “intend,” “may,” “might,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “will,” “would” and
statements in the future tense are forward-looking statements.
These forward-looking statements reflect Schr�dinger’s current
views about its plans, intentions, expectations, strategies and
prospects, which are based on the information currently available
to the company and on assumptions the company has made. Actual
results may differ materially from those described in these
forward-looking statements and are subject to a variety of
assumptions, uncertainties, risks and important factors that are
beyond Schr�dinger’s control, including the uncertainties inherent
in drug development and commercialization, such as the conduct of
research activities and the timing of and its ability to initiate
and complete preclinical studies and clinical trials, whether
results from preclinical and early clinical studies will be
predictive of the results of later preclinical studies and clinical
trials, uncertainties associated with the regulatory review of
clinical trials and applications for marketing approvals and the
ability to retain and hire key personnel on its business and other
risks detailed under the caption “Risk Factors” and elsewhere in
the company’s Securities and Exchange Commission filings and
reports, including its Quarterly Report on Form 10-Q for the fiscal
quarter ended September 30, 2023, filed with the Securities and
Exchange Commission on November 1, 2023, as well as future filings
and reports by the company. Any forward-looking statements
contained in this press release speak only as of the date hereof.
Except as required by law, Schr�dinger undertakes no duty or
obligation to update any forward-looking statements contained in
this press release as a result of new information, future events,
changes in expectations or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20231210358409/en/
Matthew Luchini (Investors) Schr�dinger, Inc.
matthew.luchini@schrodinger.com 917-719-0636
Allie Nicodemo (Media) Schr�dinger, Inc.
allie.nicodemo@schrodinger.com 617-356-2325
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