Shattuck Labs to Present Additional Data from the Phase 1B Dose Expansion Clinical Trial of SL-172154 with Azacitidine (AZA) in Frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) Patients at the Eu
14 Mai 2024 - 10:15PM
Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage
biotechnology company pioneering the development of bifunctional
fusion proteins as a new class of biologic medicine for the
treatment of patients with cancer and autoimmune disease, today
announced the presentation of additional data from the Phase 1B
dose expansion clinical trial of SL-172154 with AZA in frontline
HR-MDS and TP53m AML patients. These data will be featured in a
poster presentation at the EHA 2024 Congress, being held June
13-16, 2024, both virtually and in Madrid, Spain.
“We are rapidly progressing in our clinical development of
SL-172154. After completing initial enrollment in the fourth
quarter of 2023, we elected to expand both the frontline HR-MDS and
TP53m AML cohorts this year,” said Dr. Lini Pandite, MBChB, M.B.A.,
Chief Medical Officer of Shattuck. “The complete response rate in
HR-MDS increased by the February 1st data cutoff, and the ORR
increased in the TP53m AML cohort. This is encouraging because many
patients were still early in their course of treatment. With the
next planned data cutoff in the late second quarter of 2024, we are
well positioned to provide an update at the EHA Annual Congress. We
believe these data will further underscore the therapeutic
potential of SL-172154 for patients with previously untreated
HR-MDS and TP53m AML.”
The full abstract (#P773) is accessible on the EHA Congress
portal, and additional details are provided below.
- Title: Phase 1B Study of SL-172154, a
Bi-functional Fusion Protein Targeting CD47 and CD40, with
Azacitidine in Previously Untreated Acute Myeloid Leukemia and
Higher-Risk Myelodysplastic Syndromes
- Presenter: Dr. Amer Zeidan
- Format: Poster Presentation
- Date and Time: June 14th at 18:00 CEST
Key Takeaways from Phase 1B Trial of SL-172154 in
Frontline HR-MDS and TP53m AMLKey takeaways: Interim
efficacy as of February 1, 2024 observed for SL-172154 in
combination with AZA in frontline HR-MDS and TP53m AML. EHA poster
presentation to include additional data from the next planned
cutoff in the second quarter of 2024.
- HR-MDS: In 23 evaluable patients (20 had
TP53m, 21 had complex karyotype, and seven had therapy-related
MDS), the objective response rate (ORR) was 65%.
- Nine patients achieved a CR within 16 weeks as the median time
to CR. None of the patients with CR progressed as of the data
cutoff.
- 16 patients were still undergoing treatment.
- TP53m AML: In 14 evaluable patients (11 of
whom had secondary AML) the ORR was 36%. A total of 21 patients
will be included in the final pre-conference data cutoff.
- Two patients achieved a CR, the median time to CR was 8.7
weeks. Another patient achieved a CR with incomplete hematologic
recovery (CRi) and two patients achieved a partial response (PR).
None of the responders progressed as of the data cutoff.
- Four responders (one CR, one CRi, two PR) were taken to
hematopoietic cell transplantation (HCT)
- Six patients were still undergoing treatment, including one
patient in CR.
- Median duration of response and overall survival has not been
reached in both HR-MDS and TP53m AML as of the data cutoff
date.
Safety: SL-172154 had an acceptable safety
profile: Infusion-related reactions (IRRs) were the most
common SL-172154 related treatment-emergent adverse events
(TEAEs).
- IRR was reported in 18 patients (46%); all were Grade 1 and 2
except for two Grade 3 events. Other SL-172154 related TEAEs
(>=10%) were fatigue in five patients (13%) and hypokalemia in
four patients (10%).
- Cytokine release syndrome was reported in two patients with
HR-MDS (Grade 2 and Grade 3, respectively).
- 11 patients (28%) experienced at least one Grade 3/4 SL-172154
related TEAE, with fatigue, febrile neutropenia, and IRR as the
most common (in two patients each).
- Two patients had drug discontinuation that were possibly
related to SL-172154: one patient had a Grade 4 event of myocardial
infarction, and one patient had a Grade 5 event of cardiac arrest.
Both patients had a history of significant cardiovascular disease,
adverse risk factors and other comorbidities.
About SL-172154SL-172154 (SIRPα-Fc-CD40L) is an
investigational ARC® fusion protein designed to simultaneously
inhibit the CD47/SIRPα checkpoint interaction and activate the CD40
costimulatory receptor to bolster an anti-tumor immune response in
patients with advanced cancer. Multiple Phase 1 clinical trials are
ongoing for patients with platinum-resistant ovarian cancer
(NCT04406623, NCT05483933) and patients with AML and HR-MDS
(NCT05275439).
About Shattuck Labs, Inc.Shattuck Labs, Inc.
(Nasdaq: STTK) is a clinical-stage biotechnology company pioneering
the development of bi-functional fusion proteins as a new class of
biologic medicine for the treatment of patients with cancer and
autoimmune disease. Compounds derived from Shattuck’s proprietary
Agonist Redirected Checkpoint (ARC®) platform are designed to
simultaneously inhibit checkpoint molecules and activate
costimulatory molecules with a single therapeutic. The company’s
lead SL-172154 (SIRPα-Fc-CD40L) program, which is designed to block
the CD47 immune checkpoint and simultaneously agonize the CD40
pathway, is being evaluated in multiple Phase 1 trials. Shattuck
has offices in both Austin, Texas and Durham, North Carolina. For
more information, please visit: www.ShattuckLabs.com.
Forward-Looking StatementsCertain statements in
this press release may constitute “forward-looking statements”
within the meaning of the federal securities laws, including, but
not limited to, statements regarding: future presentations of
clinical data; clinical development plans and strategies for
SL-172154; timing of anticipated clinical data; future plans for
Shattuck’s pipeline; and Shattuck’s strategies. Words such as
“anticipate,” “may,” “might,” “will,” “objective,” “intend,”
“should,” “could,” “can,” “would,” “expect,” “believe,” “design,”
“estimate,” “predict,” “potential,” “develop,” “plan” or the
negative of these terms, and similar expressions, or statements
regarding intent, belief, or current expectations, are
forward-looking statements. While the company believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to the company on the date of this
release. These forward-looking statements are based upon current
estimates and assumptions and are subject to various risks and
uncertainties (including, without limitation, those set forth in
Shattuck’s filings with the U.S. Securities and Exchange Commission
(SEC)), many of which are beyond the company’s control and subject
to change. Actual results could be materially different. Risks and
uncertainties which could cause such outcomes to change include:
global macroeconomic conditions and related volatility;
expectations regarding the initiation, progress, and expected
results of Shattuck’s preclinical studies, clinical trials and
research and development programs; expectations regarding the
timing, completion and outcome of the company’s clinical trials;
the unpredictable relationship between preclinical study results
and clinical study results; the timing or likelihood of regulatory
filings and approvals; liquidity and capital resources and other
risks and uncertainties identified in Shattuck’s Annual Report on
Form 10-K for the year ended December 31, 2023 and subsequent
disclosure documents filed with the SEC. Shattuck claims the
protection of the Safe Harbor contained in the Private Securities
Litigation Reform Act of 1995 for forward-looking statements.
Shattuck expressly disclaims any obligation to update or alter any
statements whether as a result of new information, future events or
otherwise, except as required by law.
The Company intends to use the investor relations portion of its
website as a means of disclosing material non-public information
and for complying with disclosure obligations under Regulation
FD.
Investor & Media Contact: Conor
RichardsonVice President of Investor RelationsShattuck Labs,
Inc.InvestorRelations@shattucklabs.com
Shattuck Labs (NASDAQ:STTK)
Historical Stock Chart
Von Mai 2024 bis Jun 2024
Shattuck Labs (NASDAQ:STTK)
Historical Stock Chart
Von Jun 2023 bis Jun 2024