SGR-1505 was observed to have a favorable
safety profile and was well tolerated, with encouraging preliminary
efficacy in patients with relapsed/refractory B-cell
malignancies
Responses observed across a broad range of
B-cell malignancies, including monotherapy responses in patients
with CLL and Waldenstr�m macroglobulinemia
Management to host a webcast today at 8:00 a.m.
ET
Schr�dinger, Inc. (Nasdaq: SDGR) today announced encouraging
initial clinical data from its ongoing Phase 1, open-label,
dose-escalation study of SGR-1505 in patients with
relapsed/refractory B-cell malignancies. SGR-1505 was observed to
be safe, well tolerated, and clinically active, with responses
observed in multiple histologies, including in patients with
chronic lymphocytic leukemia (CLL) and Waldenstr�m
macroglobulinemia (WM). These data are being presented in a poster
presentation at the European Hematology Association Annual
Congress.
“We are very encouraged by the initial results from our Phase 1
study in patients with relapsed/refractory B-cell malignancies. The
data presented today, coupled with the differentiated preclinical
and safety profiles observed in our previously completed study in
healthy volunteers, further increases our conviction about the
potential for SGR-1505 to be a best-in-class therapy,” said
Margaret Dugan, M.D., chief medical officer at Schr�dinger. “Dose
escalation is complete, and we look forward to discussing these
results and our proposed recommended Phase 2 dose with the FDA
later this year.”
“Despite recent advances in the treatment of B-cell
malignancies, resistance to currently available therapies
eventually results in treatment failure and disease progression for
many patients,” said Stephen Spurgeon, M.D., Associate Professor of
Medicine, Oregon Health and Science University, and an investigator
for the clinical study. “We know that MALT1 plays a critical role
in key signaling pathways that drive cancer cell survival and
proliferation, making it a promising target for a broad range of
B-cell malignancies. Although these data are from an early-phase
study, they suggest SGR-1505 demonstrates on-target activity
resulting in potential clinical benefit. I look forward to seeing
additional data as the study progresses, including response data in
patients with aggressive histologies.”
“The positive data reported today represent a key milestone for
Schr�dinger and follow the clinical successes of programs advanced
by collaboration partners and companies we have co-founded,” said
Karen Akinsanya, Ph.D., president, head of therapeutics R&D and
chief strategy officer, partnerships at Schr�dinger. “These data
reinforce the power of Schr�dinger’s platform to enable the rapid
design of differentiated molecules and the impact that our
computational approach can have on a drug discovery and development
program.”
Major Takeaways from the Study
- As of the data cut-off date, May 13, 2025, 49 patients were
enrolled and evaluable for safety, including 18 patients with
CLL/SLL, nine with diffuse large B-cell lymphoma (DLBCL), six with
Waldenstr�m macroglobulinemia (WM), and five with marginal zone
lymphoma (MZL).
- Patients had a median of four (range two-nine) prior lines of
therapy, with the most common being Bruton’s tyrosine kinase (BTK)
inhibitors (55.1%), BCL-2 inhibitors (18.4%) and BTK+BCL-2
inhibitors (18.4%).
- SGR-1505 was well-tolerated with no dose-limiting toxicities or
deaths due to treatment-emergent adverse events (TEAEs). Forty
three percent of patients (n=21) experienced ≥ 1 treatment-related
adverse event (TRAE), with the most common (≥ 10%) being rash (12%)
and fatigue (12%). Ten patients (20%) experienced
treatment-emergent serious adverse events (SAEs); one was
treatment-related. All blood bilirubin increased TEAEs were
asymptomatic, reported in patients with UGT1A1 polymorphisms and
none were Grade 4.
- Inhibition of IL-2 is a pharmacodynamic biomarker for target
engagement and an exploratory endpoint in the study. Preliminary
data indicated that SGR-1505 inhibits T-cell derived IL-2 upon ex
vivo stimulation achieving the PD target of ~90% inhibition in the
majority of PD-evaluable participants treated at ≥ 150 mg QD and
all Q12H doses at steady state.
- Preliminary efficacy data indicated SGR-1505 was clinically
active as a monotherapy in a number of relapsed/refractory B-cell
malignancies. Of the 49 participants, 45 patients had at least one
follow-up disease assessment or disease progression and were
evaluable for preliminary efficacy. The overall response rate (ORR)
across all dose levels was 22% (n = 10/45). Thirteen of 49 patients
had been on treatment for ≥120 days.
- Among patients with indolent disease, 3/17 CLL/SLL, 5/5 WM, and
1/5 MZL patients responded. The responses of the three CLL
responders were independently reviewed and confirmed, and two had a
partial response (PR) with lymphocytosis (PR-L). Two of three CLL
patients with partial responses were double-exposed to BTK and
BCL-2 inhibitors, and all WM patients were exposed to BTK
inhibitors.
- The study recently began enrolling patients with aggressive
lymphomas into the 300 mg QD and 100 mg Q12H cohorts. A PR was
reported in one of four ABC-DLBCL patients.
Study Design The Phase 1 dose-escalation study
(NCT05544019) assessed SGR-1505 as a monotherapy treatment in
patients with relapsed/refractory B-cell malignancies. The primary
endpoint is the incidence and severity of adverse events and
dose-limiting toxicities. Secondary endpoints include
pharmacokinetic and pharmacodynamic measurements as well as
objective response rate, duration of response and disease control
rate.
EHA Poster Presentation Details The full abstract
(#PS1569) can be found online at www.ehaweb.org.
Poster Title: A Phase 1 study of SGR-1505, an oral,
potent, MALT1 inhibitor for relapsed/refractory (R/R) B-cell
malignancies, including chronic lymphocytic leukemia/small
lymphocytic leukemia (CLL/SLL) Presentation Date and Time:
Saturday, June 14, 2025, 6:30-7:30PM CST (12:30-1:30PM ET)
Location: Poster Session 2
About SGR-1505 SGR-1505 is an oral investigational MALT1
inhibitor being evaluated for the treatment of relapsed/refractory
B-cell malignancies. MALT1 plays a central role in key signaling
pathways that drive cancer cell survival and proliferation, making
its location downstream of BTK in the NF-κB signaling pathway an
attractive target for the development of novel therapeutics for a
potentially broad range of B-cell malignancies. In preclinical
studies, SGR-1505 was observed to be highly potent and selective,
and has demonstrated anti-tumor activity in preclinical models both
as a monotherapy and in combination with BTK and BCL-2 inhibitors.
There is also emerging therapeutic rationale supporting MALT1
inhibition as a potential treatment for inflammatory and autoimmune
disorders.
SGR-1505 was designed using Schr�dinger’s computational platform
at scale and was discovered approximately 10 months after the
company started its MALT1 program. Schr�dinger believes that
SGR-1505 is currently the most advanced MALT1 inhibitor known to be
in clinical development and has both first-in-class and
best-in-class potential. A Phase 1 study in patients with
relapsed/refractory B-cell malignancies is ongoing
(NCT05544019).
Webcast and Conference Call Information Schr�dinger will
host a conference call on Thursday, June 12, 2025, at 8:00 a.m. ET
to review the clinical opportunity for SGR-1505 and review the
Phase 1 data presented at EHA. The live webcast can be accessed
under “Events & Presentations” in the investors section of
Schr�dinger’s website,
https://ir.schrodinger.com/events-and-presentations. To participate
in the live call, please register for the call here. It is
recommended that participants register at least 15 minutes in
advance of the call. The archived webcast will be available on
Schr�dinger’s website for approximately 90 days following the
event.
About Schr�dinger Schr�dinger is transforming molecular
discovery with its computational platform, which enables the
discovery of novel, highly optimized molecules for drug development
and materials design. Schr�dinger’s software platform is built on
more than 30 years of R&D investment and is licensed by
biotechnology, pharmaceutical and industrial companies, and
academic institutions around the world. Schr�dinger also leverages
the platform to advance a portfolio of collaborative and
proprietary programs and is advancing three clinical-stage oncology
programs. Founded in 1990, Schr�dinger has approximately 800
employees operating from 15 locations globally. 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 SGR-1505, its MALT1
inhibitor, and the potential for SGR-1505 to be used for the
treatment of relapsed/refractory B-cell malignancies, including
chronic lymphocytic leukemia, small lymphocytic leukemia, and
Waldenstr�m macroglobulinemia, and Schr�dinger’s plans to engage
with regulators. 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, whether initial data from clinical results will be
predictive of the final results of the 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 quarter ended
March 31, 2025, filed with the Securities and Exchange Commission
on May 7, 2025, 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/20250612910362/en/
Matthew Luchini (Investors) matthew.luchini@schrodinger.com
917-719-0636 Allie Nicodemo (Media) allie.nicodemo@schrodinger.com
617-356-2325
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