Full Press Release Details
Shattuck Labs Announces Positive Initial Topline Data from Ongoing Phase 1 A/B Dose Expansion Clinical Trial of SL-172154 with Azacitidine in Frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) Patients
Observed 79% Objective Response Rate (ORR) in frontline HR-MDS patients, primarily with TP53
mutations; initial complete response (CR)/marrow complete response (mCR) rate of 64%
Observed 27% initial CR/complete
response with incomplete hematologic recovery (CRi) in frontline TP53m AML patients, and 5/11 evaluable patients achieved stable disease with decreasing blast counts and peripheral blood count improvement, these patients continue on treatment
SL-172154 demonstrated an acceptable safety and tolerability profile as a
monotherapy and in combination with azacitidine (AZA)
Shattuck to host conference call and webcast
today, December 13, 2023 at 8:00 a.m. ET
AUSTIN, TX & DURHAM, NC, December 13, 2023
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 initial topline dose-expansion data from its ongoing Phase 1A/B clinical trial of SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML patients. Initial data from the dose-expansion cohorts build on the complete dose-escalation data featured in a poster presentation on December 11, 2023 at the 65th ASH Annual Meeting.
Both the frontline HR-MDS and TP53m
AML expansion cohorts enrolled quickly after completion of the dose escalation study in the middle of this year, and we are pleased to share initial efficacy data, which begin to demonstrate the activity of
SL-172154 beyond what is expected of AZA alone. In dose escalation, we saw a monotherapy response to SL-172154 in a heavily
pre-treated relapsed/refractory (R/R) TP53m AML patient that allowed the patient to receive a stem cell transplant. That patient remains disease free. said Dr. Lini Pandite, MBChB, M.B.A., Chief
Medical Officer of Shattuck. In frontline, the rate of complete responses in both the HR-MDS and TP53m AML cohorts is already encouraging, and when coupled with the observation of peripheral blood count
recovery in most patients that have not yet achieved a complete response, and the fact that many of these patients are very early in their course of treatment and have not yet reached the median time at which a complete response is expected for
azacitidine, suggests that the complete response rate may continue to improve in the coming months. As a result, we have amended both studies to increase the sample size and look forward to providing another update by
Phase 1B Trial of SL-172154 in Frontline TP53m
Key takeaways: Early efficacy observed for
SL-172154 in combination with AZA in previously untreated HR-MDS and TP53m AML:
Phase 1A Trial of SL-172154 in
R/R AML and HR-MDS and Frontline TP53m HR-MDS
presentation, titled 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), is accessible under posters in the Our Science section of Shattuck s website.
Key takeaways: Anti-tumor responses were observed as monotherapy and in combination with AZA. SL-172154 alone and in
combination with AZA had an acceptable safety profile, consistent with the safety profile of the individual agents (see SL-172154 safety above). No destructive anemia was observed.
Conference Call at 8:00 a.m. ET Today
Shattuck will host a conference call today at 8:00 a.m. ET featuring key opinion leader Dr. Naval Daver, MD, (Professor, Director Leukemia Research
Alliance Program, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX) to present the initial data from the frontline expansion cohorts in HR-MDS and TP53m AML. Additionally,
a review of data from the poster presentation featured at the 65th ASH Annual Meeting will be discussed. To listen to the live webcast, please visit the Investor Relations page of the Shattuck
Labs website here. Participants may register for the call here. While not required, interested participants are encouraged to join 10 minutes prior to the start of the event.
A replay of the webcast will be available following the conclusion of the live call and will be accessible on the Company s website.
SL-172154 (SIRP -Fc-CD40L) is an investigational ARC fusion protein designed to simultaneously inhibit the CD47/SIRP
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 (SIRP -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 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, the clinical benefit of SL-172154 in frontline HR-MDS and TP53m AML patients, the safety and tolerability profile of SL-172154, and the anticipated timing of additional data from our clinical trials. 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:
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