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 provided a corporate update and highlighted
upcoming key milestones anticipated in 2023.
“Throughout 2022, we focused on clinical execution to position
ourselves for key clinical data readouts for SL-172154 in 2023.
These milestones are now rapidly approaching for both solid tumor
and hematologic indications. Importantly, in 2022 we completed the
monotherapy dose-escalation study and selected a dose of SL-172154
to advance into combination studies with liposomal doxorubicin for
patients with platinum-resistant ovarian cancer. In addition, we
have established a collaboration with ImmunoGen to combine
SL-172154 with mirvetuximab soravtansine, also in the
platinum-resistant ovarian cancer patient population. As for our
heme program, we are enrolling well and have advanced into the
azacitidine combination cohorts for patients with AML or HR-MDS,”
said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of
Shattuck Labs. “We are looking forward to sharing data in 2023
which we believe will establish SL-172154 as both a differentiated
CD47 inhibitor and a CD40 agonist capable of fully activating the
CD40 pathway in human cancer patients. We expect that these data
will position Shattuck well for continued growth in the years
ahead.”
Key Accomplishments in 2022
ARC Platform
SL-172154 (SIRPα-Fc-CD40L)
- Completed enrollment in Phase 1 dose-escalation clinical trial
of SL-172154 as monotherapy in platinum-resistant ovarian
cancer
- Dosed first patients in ongoing Phase 1B clinical trial of
SL-172154 in combination with liposomal doxorubicin in
platinum-resistant ovarian cancer
- Initiated Phase 1B clinical trial of SL-172154 in combination
with mirvetuximab soravtansine in platinum-resistant ovarian
cancer
- Dosed first patients in first combination cohort with
azacitidine in ongoing Phase 1A/B clinical trial of in SL-172154 in
acute myeloid leukemia (AML) and higher-risk myelodysplastic
syndromes (HR-MDS)
- Provided clinical data for intratumorally administered
SL-172154 in Phase 1 clinical trial in squamous cell carcinoma of
the head and neck or skin
SL-279252 (PD1-Fc-OX40L)
- Advanced enrollment into final dose-escalation cohorts at 12
and 24 mg/kg in ongoing Phase 1 clinical trial of SL-279252 in
advanced solid tumors and lymphomas
SL-9258 (TIGIT-Fc-LIGHT)
- Presented data on the preclinical development of SL-9258 at
the Protein and Antibody Engineering Summit (PEGS) conference
and published the associated preclinical manuscript in the Journal
of Immunology
- Presented preclinical data on SL-9258 at the American
Association for Cancer Research (AACR) Annual Meeting
GADLEN Platform
GADLEN Preclinical Product Candidates
- Announced two potential lead candidates from the GADLEN
platform in 2023, one targeting the CD20 antigen intended for
development in autoimmune disease and a second targeting the B7H3
antigen for development in oncology
- Data from two potential lead candidates were presented at both
the Gamma Delta T Therapies Summit Meeting and Society for
Immunotherapy of Cancer (SITC) Annual Meeting
Clinical Milestones Expected in 2023
ARC Platform
SL-172154 (SIRPα-Fc-CD40L)
- Complete data from Phase 1 dose-escalation clinical trial of
SL-172154 as monotherapy in platinum-resistant ovarian cancer
expected midyear 2023
- Initial data from Phase 1B clinical trial of SL-172154 in
combination with liposomal doxorubicin in platinum-resistant
ovarian cancer expected midyear 2023
- Initial dose-escalation data, as monotherapy and in combination
with azacitidine, for Phase 1A/B clinical trial of SL-172154 in AML
and HR-MDS expected in 1H’2023
- Complete dose-escalation data, as monotherapy and in
combination with azacitidine, for Phase 1A/B clinical trial of
SL-172154 in AML and HR-MDS and initial dose-expansion cohort data
expected in 2H’2023
- Initial data from Phase 1B clinical trial of SL-172154 in
combination with mirvetuximab soravtansine in platinum-resistant
ovarian cancer expected 2H’2023
SL-279252 (PD1-Fc-OX40L)
- Go/no-go decision from the Phase 1 dose-escalation clinical
trial of SL-279252 in advanced solid tumors or lymphoma in
1Q’2023
GADLEN Platform
GADLEN Preclinical Product Candidates
- Additional clinical development detail and further program
guidance regarding the advancement of potential product candidates
from the GADLEN platform in 2023
Cash Position and Financial Guidance
Shattuck Labs ended the third quarter of 2022 with approximately
$185.1 million in cash and cash equivalents and investments. The
Company expects that its cash and cash equivalents and investments
will be sufficient to fund its planned operations into
the second half of 2024.
Upcoming Presentations
Conference: 41st Annual J.P. Morgan Healthcare
ConferenceFormat: Corporate PresentationPresenter: Taylor
Schreiber, M.D., Ph.D., Shattuck’s Chief Executive
OfficerDate: January 12, 2023Time: 2:15 p.m. ET
A live audio recording of the presentation will be available on
the Investors section of the Company’s website. A replay
of the webcast will be archived for up to 30 days following the
presentation date.
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 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. A
second product candidate, SL-279252 (PD1-Fc-OX40L), is being
evaluated in a Phase 1 trial in solid tumors or lymphomas.
Additionally, the company is advancing a proprietary Gamma Delta T
Cell Engager, GADLEN™, platform, which is designed to bridge gamma
delta T cells to tumor antigens for the treatment of patients with
cancer. Shattuck has offices in both Austin, Texas and Durham,
North Carolina. For more information, please
visit: http://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, our expectations
regarding plans for our preclinical studies, clinical trials and
research and development programs, the anticipated timing of the
results from our clinical trials, anticipated timing for
preclinical development updates, potential clinical benefit of our
product candidates, and expectations regarding the time period over
which our capital resources will be sufficient to fund our
anticipated operations. 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: the recent and ongoing
COVID-19 pandemic; 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, 2021, 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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