Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage
biotechnology company pioneering the development of bifunctional
fusion proteins as a potential new class of biologic medicine for
the treatment of patients with cancer and autoimmune disease, today
announced updated interim data from the Phase 1B dose expansion
clinical trial of SL-172154 in combination with AZA in frontline
HR-MDS and TP53m AML patients. These data are to be featured in a
poster presentation on June 14, 2024 at 18:00 CEST, during the
European Hematology Association (EHA) 2024 Congress.
“We are pleased to present additional data from our Phase 1B
dose expansion clinical trial, which further supports our
differentiated mechanism of action and underscores SL-172154’s
emergence as the leading CD47 inhibitor in hematologic
malignancies,” said Taylor Schreiber, M.D., Ph.D., Chief Executive
Officer of Shattuck. “This update shows that the rate of complete
remission has improved since our last data release in December,
with additional patients in both cohorts who continue to improve on
therapy. As a result of these encouraging data, and our expectation
of rapid enrollment and progress in our ongoing randomized,
controlled cohort in HR-MDS, we are focusing our efforts on our
opportunity in HR-MDS and TP53m AML. These are indications with
high unmet need, limited competition, and potential for accelerated
paths to approval.”
Dr. Lini Pandite, MBChB, M.B.A., Chief Medical Officer of
Shattuck added, “We are encouraged by the maturing data that
continues to underscore the therapeutic potential, and manageable
safety profile, of SL-172154 for patients with previously untreated
HR-MDS and TP53m AML. Accumulating clinical evidence now shows the
pharmacodynamic contribution of CD40 activation in the peripheral
blood, and an emerging correlation between clinical remission and
CD40 mediated induction of certain cytokines. The TP53m AML and
HR-MDS patients we have treated represent a high-risk group with
short duration of complete remission and overall survival when
treated with azacitidine alone. Median overall survival and
duration of remission have not yet been achieved, and we look
forward to sharing additional durability data later this year.
Enrollment is now underway for our randomized, controlled expansion
cohort in frontline HR-MDS patients, and we expect to engage in
regulatory discussions later this year regarding the registrational
strategy for SL-172154.”
A copy of the EHA poster, titled “Phase 1b Study of SL-172154, a
Bi-functional Fusion Protein Targeting CD47 and CD40, in
Combination with Azacitidine (AZA) in Previously Untreated Acute
Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic
Syndromes/Neoplasms (HR- MDS) Patients (pts),” will be made
available under posters in the Our Science section of Shattuck’s
website.
Phase 1B Trial of SL-172154 in Frontline HR-MDS and
TP53m AMLKey takeaways: Additional
interim efficacy observed for SL-172154 in combination with AZA in
frontline HR-MDS and TP53m AML.
- HR-MDS: As of the data cut-off date of April
23, 2024, in 24 treated patients (21 had TP53m, 16 had complex
karyotype, and seven had therapy-related MDS), the ORR was 67%.
- Ten (42%) patients achieved a CR with 3.6 months as the median
time to CR.
- Nine patients are continuing on treatment (five CR, two mCR+HI,
one SD+HI, one SD).
- Three patients proceeded to allogeneic hematopoietic cell
transplantation (HCT), all three patients achieved CR prior to
HCT.
- TP53m AML: As of the data cut-off date of June
4, 2024, in 21 treated patients (all 21 had TP53 mutations or
deletion, 19 had a complex karyotype, and 14 had secondary AML) the
ORR was 43%.
- Six (29%) patients achieved a CR. One patient achieved a CRi
and two patients achieved a partial remission (PR). The median time
to CR was 3.8 months and none of the responders progressed as of
the data cutoff.
- Five responders (three CR, one CRi, one PR) were taken to HCT
and seven patients were still undergoing treatment, including two
patients in CR. Additional patients may be bridged to transplant in
the coming months.
- Preliminary analysis indicates clearance of TP53 mutation in
four out of five TP53m HR-MDS patients and two out of four TP53m
AML patients who achieved CR and were evaluated as of the data
cutoff.
- Median duration of response for OR and CR and overall survival
had not yet been reached in either HR-MDS or TP53m AML as of the
respective data cutoff dates.
Safety Results: As of the data cutoff date of
April 23, 2024, SL-172154 showed a manageable safety
profile: Infusion-related reactions (IRRs) were the most
common SL-172154 treatment-emergent adverse events (TEAEs). There
have been no G3 or higher IRRs when patients have been premedicated
with dexamethasone. There was no evidence of hemolytic
(destructive) anemia.
- HR-MDS:
- Grade 3/4 AEs were reported in ten (42%) patients as
related/possibly related to SL-172154: IRR (n=3), febrile
neutropenia (n=2), anemia, alkaline phosphate increased,
chondrocalcinosis, colitis, cytokine release syndrome, decreased
appetite, fatigue, hypertension, left ventricular dysfunction,
myocardial infarction (MI), neutropenia, pancytopenia,
thrombocytopenia, troponin I increase, each in one patient.
- There was one death due to AE of sepsis, deemed unrelated to
SL-172154, and three treatment discontinuations due to AEs,
including MI (n=1), IRR (n=1) and sepsis (n=1).
- As already reported in the Company’s May 2024 EHA abstract, a
Grade 4 MI occurred in one patient who first developed sepsis
on-study. This patient had a history of coronary artery
disease and type II diabetes. The MI occurred eight days after the
last dose of SL-172154. Although reported by the investigator as
possibly related, Shattuck’s assessment is that this event was
unlikely related to SL-172154.
- TP53m AML:
- Grade 3/4 AEs were reported in seven patients (33%), as
related/possibly related to SL-172154, including neutropenia
(n=3), thrombocytopenia (n=2), leukopenia (n=2), ALT increased
(n=1), AST increased (n=1), enterococcal bacteremia (n=1), fatigue
(n=1), hypoxia (n=1) and pneumonia (n=1).
- There were three deaths due to AEs deemed unrelated to
SL-172154 including sepsis (n=1) and pneumonia (n=2).
- As already reported in the Company’s December 2023 update for
the ASH Annual Meeting, a Grade 5 cardiac arrest occurred in one
patient with a history of significant cardiovascular disease, prior
MI, prior stenting, prior arrhythmia, hypokalemia in the setting of
amiodarone, additional adverse risk factors and other
comorbidities. Although reported by the investigator as possibly
related, Shattuck’s assessment is that this event was unlikely
related to SL-172154.
Key Takeaways from Phase 1B Trial of SL-172154 in
Platinum-Resistant Ovarian Cancer (PROC)SL-172154 in
combination with pegylated liposomal doxorubicin (PLD) or
mirvetuximab soravtansine (Elahere)
- Interim efficacy results as of April 23, 2024, showed four of
21 (19%) treated patients in our Phase 1B study of SL-172154 in
combination with PLD have achieved partial responses. The
Javelin-200 study reported an ORR of 4% with PLD alone. Two
additional patients with stable disease showed maximum tumor
reductions of 17% and 27% and were continuing on study. The Company
is continuing to follow patients for progression free survival and
overall survival.
- In our cohort combining SL-172154 with Elahere, the Company has
completed enrollment. As of the April 23, 2024 data cutoff, the
Company has not observed an ORR benefit beyond Elahere alone, and
the Company plans to further follow patients for progression free
survival and overall survival.
- Both of these combinations, SL-172154 combined with PLD and
SL-172154 combined with Elahere, have shown an acceptable safety
profile with IRRs as the most common treatment emergent AE as of
the data cutoff.
- The Company is not currently planning to conduct additional
clinical development in PROC, in part due to the evolving
competitive landscape in this indication. Should progression free
survival or overall survival mature favorably in either PROC
cohort, we would evaluate further development in PROC at that time.
Shattuck will focus all current later-stage clinical development
efforts in AML and HR-MDS due to the strength of the emerging
efficacy results in those patient populations, the limited
competition, and the potential for these indications to be the
fastest path to registration.
Conference Call at 7:30 a.m. ET TodayShattuck
will host a conference call today at 7:30 a.m. ET featuring lead
investigator Dr. Naval Daver, MD, (Professor and the Director of
the Leukemia Research Alliance Program in the Department of
Leukemia and MD Anderson Cancer Center in Houston, TX) to discuss
the data from the poster presentation featured at the EHA 2024
Congress, including an interim safety and efficacy update from the
frontline expansion cohorts in HR-MDS and TP53m AML. 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.
About SL-172154SL-172154 (SIRPα-Fc-CD40L) is an
investigational Agonist Redirected Checkpoint (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 potential new
class of biologic medicine for the treatment of patients with
cancer and autoimmune disease. Compounds derived from Shattuck’s
proprietary 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; the potential failure of a
clinical trial to provide sufficient results to merit further
development; 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
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