Reports data showing SGR-1505 is well-tolerated
and achieves target engagement in Phase 1 healthy volunteer
study
Highlights expanding portfolio including
newly-disclosed EGFRC797S, PRMT5-MTA and NLRP3 programs
Outlines broad discovery and development
efforts targeting synthetic lethality and DNA-damage repair
mechanisms, including PRMT5-MTA, SGR-3515 and SGR-2921 programs
Schr�dinger (Nasdaq: SDGR), whose physics-based computational
platform is transforming the way therapeutics and materials are
discovered, is providing a detailed review of its proprietary drug
discovery and development programs during its Pipeline Day today,
December 14, from 10:00 a.m. - 12:30 p.m. ET.
“We are excited to share our first clinical data for a
proprietary Schr�dinger program, SGR-1505, and to outline the
opportunities emerging from our broad portfolio of drug discovery
programs in multiple therapeutic areas, including oncology,
immunology and neurology,” stated Karen Akinsanya, Ph.D., president
of R&D, therapeutics at Schr�dinger. “Our therapeutics team has
been very productive since we started building this portfolio. With
two programs in the clinic, multiple programs in late discovery and
preclinical development, and our advancing collaborations, we
believe the future of our therapeutics portfolio is very
promising.”
SGR-1505 Clinical Progress and Program Update
During Pipeline Day, Schr�dinger is presenting new data showing
that its novel MALT1 inhibitor, SGR-1505, was well tolerated in a
Phase 1 study of 73 healthy volunteers. No drug-related serious
adverse events or dose limiting toxicities were observed in the
study. In the study, SGR-1505 achieved greater than 90 percent
inhibition of IL-2 secretion in activated T cells, confirming
target engagement and meeting the pharmacodynamic goals for the
study. The data support continued evaluation of SGR-1505 in the
ongoing Phase 1 study in patients with relapsed or refractory
B-cell malignancies.
“The data presented from our successful healthy volunteer study
demonstrate that SGR-1505 is well-tolerated with a pharmacokinetic
and pharmacodynamic profile that supports continued development,”
stated Margaret Dugan, M.D., chief medical officer at Schr�dinger.
“These data add significantly to our understanding of SGR-1505 and
inform our clinical development strategy in hematologic
malignancies. The SGR-1505 program is progressing well, and we look
forward to continued enrollment in the patient study and reporting
initial data in late 2024 or 2025.”
Schr�dinger is also presenting preclinical data for SGR-1505
demonstrating that SGR-1505 has favorable attributes and the
potential for combination activity with standard-of-care agents in
B cell malignancies. These data were presented earlier this week at
the American Society of Hematology Annual Meeting.
Three New Programs: EGFRC797S, PRMT5-MTA and NLRP3
Schr�dinger is presenting three new proprietary discovery
programs at Pipeline Day, targeting EGFRC797S, PRMT5-MTA and
NLRP3.
EGFR inhibitors are first-line standard of care agents for
advanced non-small cell lung cancer patients with activating EGFR
mutations, but relapse often occurs due to the development of
resistance mutations, including EGFRC797S. Schr�dinger has
identified multiple EGFRC797S inhibitors and is advancing wild-type
sparing, double mutant CNS-penetrant inhibitors with the potential
to address brain metastases in patients whose disease progresses
following first-line treatment, and to potentially achieve deeper,
more durable responses through new combination regimens.
PRMT5-MTA inhibition has demonstrated clinical responses in both
hematologic and solid tumors with improved safety versus PRMT5
inhibitors due to a synthetic lethal targeting of cancer cells with
MTAP-deletions. Schr�dinger has identified selective, potent
PRMT5-MTA inhibitors with potential applications in solid tumors,
brain metastases and primary CNS tumors.
NLRP3 is a validated target, and mutations in the NLRP3 gene are
associated with a broad spectrum of inflammatory and auto-immune
diseases. Schr�dinger has identified structurally distinct,
selective, NLRP3 inhibitors with anti-inflammatory activity in
preclinical models, and is continuing to optimize peripheral and
brain-penetrant leads.
Broad Portfolio Addresses Synthetic Lethality and DNA-Damage
Repair
Schr�dinger is advancing multiple oncology programs designed to
exploit the intrinsic vulnerabilities of cancer cells through
synthetic lethality and inhibition of DNA-damage repair. Today, the
company is discussing its synthetic lethality programs, PRMT5-MTA
and SGR-3515 (Wee1/Myt1). The company is also reviewing SGR-2921,
which targets CDC7, a key regulator of replication stress and
DNA-damage repair.
Schr�dinger is reporting preclinical data showing that SGR-3515
has a differentiated biochemical, biophysical and functional
profile, with sustained inhibition of Wee1 and Myt1 in tumor cells.
Concurrent loss of function of Wee1 and Myt1 confers selective
vulnerability in cancer cells and could offer increased anti-tumor
activity. SGR-3515 has potential to treat a broad range of solid
tumors, including uterine and ovarian cancers. Schr�dinger plans to
submit an IND for SGR-3515 in the first half of 2024.
Schr�dinger is also discussing preclinical data presented at ASH
demonstrating that SGR-2921 exhibited better activity compared to
other CDC7 inhibitors, and showed anti-proliferative effects in
treatment-resistant acute myeloid leukemia (AML) patient-derived
samples, as well as reduction of blasts in multiple AML models. A
Phase 1 study of SGR-2921 is ongoing in patients with AML or
myelodysplastic syndrome, and the company expects to report initial
data from the study in late 2024 or 2025.
“CDC7 is a promising therapeutic target for the treatment of
myelodysplastic syndromes and acute myeloid leukemia, diseases for
which there is a significant unmet need in treating both frontline
and relapsed/refractory patients,” stated Elie Traer, M.D., Ph.D.,
associate professor at the Center for Hematologic Malignancies at
Oregon Health & Science University. “Targeting CDC7 with
emerging investigational therapeutics, such as SGR-2921, represents
an opportunity to expand our armamentarium of treatment options
beyond existing targeted therapies.”
Anticipated Milestones
Today, Schr�dinger outlined the anticipated milestones for its
proprietary pipeline:
- Report initial data from the Phase 1 study of SGR-1505 in late
2024 or 2025
- Report initial data from the Phase 1 study of SGR-2921 in late
2024 or 2025
- Submit IND for SGR-3515 in the first half of 2024 and initiate
a Phase 1 study in 2024
- Submit an IND from its discovery portfolio in 2025
Event Information
Schr�dinger’s Pipeline Day will begin at 10:00 a.m. ET and is
expected to conclude at approximately 12:30 p.m. ET. The live
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 more than 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, SGR-2921 and SGR-3515, 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, the ability to
identify any new product candidates, including from the company’s
newly announced drug discovery programs, the timing, progress, and
results of clinical trials for its product candidates, and the
expected timing of additional IND submissions to the FDA for any
product candidates the company identifies. 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 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/20231214384353/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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