Shattuck Labs to Present Topline Data from Phase 1 A/B Clinical Trial of SL-172154 in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS) Patients at the American Society of Hematology (ASH) 2023 Annual
02 Noviembre 2023 - 7:01AM
Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), 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, today
announced the presentation of topline data from the dose escalation
portion of its Phase 1 A/B clinical trial of SL-172154 as
monotherapy and in combination with azacitidine (AZA) in primarily
R/R AML and HR-MDS patients. These data will be featured in a
poster presentation at the 65th ASH Annual Meeting, which is being
held both virtually and in San Diego, CA from December 9-12, 2023.
“Response rates are historically low for heavily pretreated
relapsed/refractory AML and HR-MDS patients. We were particularly
pleased to observe initial anti-leukemic activity, unique
pharmacodynamic activity, and an acceptable safety and tolerability
profile for SL-172154 as monotherapy and in combination with
azacitidine. We are excited to continue development of our unique
bifunctional protein SL-172154, as we seek to improve the lives of
patients with hematologic malignancies.” said Dr. Lini Pandite,
MBChB, M.B.A., Chief Medical Officer of Shattuck. “The observation
of a monotherapy response, dose-dependent increases in serum
cytokines, and accumulation of mature myeloid cells in bone marrow
support a potential contribution of CD40 stimulation in these heme
malignancies. Notably, preliminary data shows anti-leukemic effects
detected in previously untreated TP53m-MDS and R/R AML patients. We
look forward to sharing additional data from the frontline
expansion cohorts later this year. Overall, we are encouraged by
the growing body of data that further validates the unique
mechanism of action of SL-172154 and its therapeutic potential to
address the unmet needs for patients with AML and HR-MDS.”
The full abstract (#4278) is accessible on the ASH Congress
portal, and additional details are provided below.
- Title: Safety, Pharmacodynamic, and Anti-Tumor Activity of
SL-172154 as Monotherapy and in Combination with Azacitidine (AZA)
in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and
Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) Patients
(pts)
- Session Title: Acute Myeloid Leukemias: Investigational
Therapies, Excluding Transplantation and Cellular Immunotherapies:
Poster III
- Presenter: Dr. Naval Daver
- Format: Poster Presentation
- Session Date: Monday, December 11, 2023
- Time: 6:00 PM - 8:00 PM PT
Key Takeaways: SL-172154 monotherapy response
was observed in a heavily pretreated patient with R/R AML after
just a single cycle of treatment, as well as early efficacy signals
for SL-172154 in combination with AZA in previously untreated
HR-MDS with TP53 mutant patients. SL-172154 was tolerable at 3mg/kg
as a monotherapy and in combination with AZA.
- Data Overview: As of the abstract data cut-off
date of May 25, 2023, 37 adult patients with R/R AML and HR-MDS had
received SL-172154 as monotherapy or in combination with AZA in the
parallel staggered dose-escalation portion of a Phase 1A/B clinical
trial. Patients had a median of two prior lines of therapy.
- Preliminary signs of anti-leukemic activity:
Monotherapy response in a R/R AML patient and early signals of
anti-leukemic activity (in the form of blast count reductions) in
patients with R/R AML who received SL-172154 in combination with
AZA were observed in a dose-dependent manner. Early signals of
activity with SL-172154 in combination with AZA in frontline
patients with TP53 mutant HR-MDS were observed.
- SL-172154 monotherapy response (Morphologic Leukemia-Free
State) (n=1 at 6 mg/kg) was observed in a heavily pretreated R/R
AML patient who subsequently proceeded to allogeneic hematopoietic
cell transplantation (allo-HCT).
- Anti-leukemic activity, in the form of blast count reductions,
was observed in R/R AML patients in combination with AZA (n=2 at 1
mg/kg, n=5 at 3 mg/kg) and one patient subsequently proceeded to
allo-HCT.
- Out of four evaluable previously untreated HR-MDS with TP53m
patients, there was one confirmed complete response (3 mg/kg), one
marrow complete response (1 mg/kg), and two stable diseases (n=1 at
1 mg/kg, n=1 at 6 mg/kg). Two patients subsequently proceeded to
allo-HCT.
- SL-172154 had an acceptable safety profile as
monotherapy and in combination with AZA.
- Infusion-related reactions (IRRs) were the most common
SL-172154-related treatment-emergent AEs (TEAEs) and were reported
in 13 patients (68%) as monotherapy and 8 patients (44%) in
combination with AZA.
- Other TEAEs observed were increased AST (aspartate
aminotransferase) (4; 21%), ALT (alanine aminotransferase) (3; 16%)
and nausea (3; 17%) in monotherapy cohorts, and nausea (3; 17%) in
combination cohorts. All events of increased AST/ALT were
transient.
- SL-172154 in combination with AZA had an acceptable safety
profile with one dose-limiting toxicity event at 6mg/kg of
SL-172154. The dose of 3 mg/kg is being evaluated in the dose
expansion.
- CD47 and CD40 target engagement and CD40-dependent
pharmacodynamic effects observed at the 3 mg/kg dose.
- SL-172154 induced elevations in serum IL-12p40, IP-10, IL-8,
IL-10, MIP3α, and MCP1 with greater response at 3 mg/kg compared to
1 mg/kg and similar response between 3 mg/kg and 6 mg/kg.
- In bone marrow, abundant staining of SL-172154 was observed,
along with a dose-dependent increase in phagocytic cells within
mature myeloid immune cell compartments. Reduction in leukemic
blasts was associated with an increase in mature myeloid and
phagocytic cell phenotypes.
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 PROC (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, the therapeutic potential, efficacy and clinical
benefits of SL-172154, the safety, pharmacodynamic and tolerability
profile of SL-172154, the anticipated timing of the results from
our expansion cohorts, and potential clinical benefit of our
product candidates. Words such as “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 we believe 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 us 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 our filings with the U.S. Securities
and Exchange Commission (the “SEC”)), many of which are beyond our
control and subject to change. Actual results could be materially
different. Risks and uncertainties include: global macroeconomic
conditions and related volatility, expectations regarding the
initiation, progress, and expected results of our preclinical
studies, clinical trials and research and development programs;
expectations regarding the timing, completion and outcome of our
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 our
Annual Report on Form 10-K for the year ended December 31, 2022,
and subsequent disclosure documents filed with the SEC. We claim
the protection of the Safe Harbor contained in the Private
Securities Litigation Reform Act of 1995 for forward-looking
statements. We expressly disclaim 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
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