Shattuck Labs to Present Complete Dose-Escalation Data from Phase 1A Monotherapy Clinical Trial of SL-172154 in Platinum-Resistant Ovarian Cancer (PROC) at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting
25 Maggio 2023 - 11:15PM
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 complete dose-escalation data from
the Phase 1A monotherapy clinical trial of SL-172154 in PROC. These
data will be featured in a poster presentation at the ASCO Annual
Meeting, being held both virtually and in Chicago, IL from June
2-6, 2023.
“We are excited to present data at ASCO that we believe
positions SL-172154 as a differentiated CD47 inhibitor and further
underscores its therapeutic potential in heavily pretreated PROC
patients,” said Dr. Lini Pandite, MBChB, M.B.A., Chief Medical
Officer of Shattuck. “We believe SL-172154, a dual CD47 inhibitor
and CD40 agonist, has a differentiated safety and pharmacodynamic
profile and its hexameric structure enables CD40 activation in a
fundamentally different manner than prior CD40 agonist therapies
studied in humans. Preliminary analysis of pre- and on-treatment
tumor biopsies further validates its mechanism of action.”
Dr. Pandite continued, “In the Phase 1A dose-escalation trial,
SL-172154 had maximal CD47 and CD40 target engagement and
CD40-dependent pharmacodynamic effects observed at the 3 mg/kg
dose. SL-172154 had a favorable safety and tolerability profile
across doses. Based on these encouraging data, we believe we have
selected the optimal dose with maximal pharmacodynamic activity,
which further supports our SL-172154 dose-expansion strategy in
combination trials for patients with PROC. Our ongoing clinical
trial of SL-172154 in combination with liposomal doxorubicin
remains on track, and we expect to share initial data midyear.
Additionally, we expect to share initial data from our clinical
trial of SL-172154 in combination with mirvetuximab soravtansine in
the second half of 2023.”
The full abstract (#5544) is accessible on the ASCO Congress
portal, and additional details are provided below.
- Title: Phase 1 dose escalation study of SL-172154
(SIRPα-Fc-CD40L) in platinum-resistant ovarian cancer
- Presenter: Nehal J. Lakhani, M.D., Ph.D., START Midwest
- Format: Poster #239
- Session Title: Gynecologic Cancer
- Session Date and Time: Monday, June 5 at 1:15 p.m. CT
Key Takeaways:
- SL-172154 was generally well
tolerated in heavily pretreated PROC patients.
- While a maximum tolerated dose was not reached, one
dose-limiting toxicity was reported of Grade 3 ALT at 10 mg/kg
requiring dose interruption for resolution.
- There were no fatal adverse events
(AEs) and no AEs that led to drug discontinuation.
- Infusion related reactions (IRR)
were the most common drug related AE and were readily manageable.
The frequency of IRR events increased with dose and slowing the
rate of infusion was utilized for mitigation.
- Best response per RECIST 1.1 was stable disease in 6 (22%)
patients.
- Maximal CD47 and CD40 target
engagement and CD40-dependent PD effects were observed with ≥ 3
mg/kg of SL-172154.
- SL-172154 exhibited greater than
dose proportional pharmacokinetics at or above 3 mg/kg, potentially
due to target saturation.
- Dose-dependent target engagement of
CD47 and CD40 on CD4 T cells and B cells, respectively, approached
100% by the 3 mg/kg dose level.
- Significant dose-dependent increases
in IL-12, along with post-dose increases in multiple other serum
cytokines, including CXCL-8, CXCL-10, IL-10, CCL2, CCL20, and
CCL22, concurrent with rapid dose-dependent egress of CD40+ B cells
and monocytes from the peripheral blood, were maximal at ≥ 3
mg/kg.
About the Phase 1A Dose Escalation Clinical
Trial As of the data cut-off of January 3, 2023, the
first-in-human, open-label, multi-center, dose-escalation clinical
trial evaluated SL-172154 as monotherapy in 27 patients with
advanced platinum-resistant ovarian, fallopian tube and primary
peritoneal cancers. SL-172154 was administered intravenously across
5 dose levels (0.1, 0.3, 1.0, 3.0, and 10.0 mg/kg). Dose escalation
followed a modified toxicity probability interval 2 design.
Objectives included evaluation of safety, dose-limiting toxicity,
recommended Phase 2 dose, pharmacokinetic and pharmacodynamic
parameters, and antitumor activity.
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
with SL-172154 are ongoing, including trials for patients with PROC
(NCT05483933) and 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 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. Additionally, the
company is advancing a proprietary Gamma Delta T Cell Engager,
GADLEN™, platform, which is designed to bridge gamma delta T cells
to cell-based antigens for the treatment of patients with cancer
and autoimmune disease. Shattuck has offices in both Austin, Texas
and Durham, North Carolina. For more information, please visit:
www.ShattuckLabs.com.
Forward-Looking Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the federal
securities laws, including, but not limited to, therapeutic
potential, efficacy and clinical benefits of SL-172154, the safety,
pharmacodynamic and tolerability profile of SL-172154, the optimal
dosing of SL-172154, SL-172154 as a potentially differentiated CD47
inhibitor, the anticipated timing of the results from our clinical
trials, 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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