“In 2023, we delivered key safety and efficacy data across our clinical development program for SL-172154 and further strengthened our financial resources, which we believe will carry us beyond upcoming milestones in the year ahead,” said
Key Accomplishments in 2023
Clinical Accomplishments
Platinum-Resistant Ovarian Cancer (PROC)
- Presented complete data from the Phase 1A clinical trial of SL-172154 as monotherapy in PROC at the
American Society of Clinical Oncology 2023 annual meeting, including data supporting 3 mg/kg as an appropriate dose of SL-172154 for each PROC combination cohort. - Completed enrollment of and presented positive interim data from the Phase 1B clinical trial of SL-172154 in combination with pegylated liposomal doxorubicin (PLD) in PROC.
- Demonstrated an acceptable safety profile and encouraging anti-tumor activity that compares favorably to PLD as a monotherapy.
- Enrollment continued to progress in the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC.
Higher-Risk Myelodysplastic Syndromes (HR-MDS) and Acute Myeloid Leukemia (AML)
- Presented results from the dose escalation portion of the Phase 1A/B clinical trial of SL-172154 in relapsed/refractory (R/R) AML and HR-MDS and frontline TP53 mutant (TP53m) HR-MDS patients as monotherapy and in combination with azacitidine (AZA) in a poster presentation at the
American Society of Hematology Annual Meeting.- Anti-leukemic responses were observed with SL-172154 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. No destructive anemia was observed.
- Completed enrollment in frontline expansion cohort in TP53m AML patients and in the frontline expansion cohort in HR-MDS patients.
- Presented positive initial topline data from the ongoing Phase 1A/B dose expansion clinical trial of SL-172154 with AZA in frontline HR-MDS and TP53m AML patients.
- Initial data suggest SL-172154 improved complete response rates relative to what would be expected historically with AZA alone in previously untreated HR-MDS and TP53m AML. SL-172154 demonstrated an acceptable safety and tolerability profile both as monotherapy and in combination with AZA.
Corporate Accomplishments
- On
December 21, 2023 , Shattuck announced a$50 million registered offering of common stock and concurrent private placement of pre-funded warrants. Net proceeds from the registered offering and the private placement are intended to further support the development of its pipeline candidates, including SL-172154.
Clinical Milestones Expected in 2024
- Complete objective response rates and initial duration of response data from the ongoing Phase 1B clinical trial of SL-172154 in combination with PLD in PROC expected mid-year 2024.
- Initial combination data from the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected mid-year 2024.
- Complete objective response rates and initial duration of response data from the Phase 1B expansion cohorts of SL-172154 in combination with AZA in frontline TP53m AML and HR-MDS expected mid-year 2024.
Cash Position and Financial Guidance
Shattuck ended the third quarter of 2023 with approximately
Upcoming Presentations
Conference: 42nd Annual J.P. Morgan Healthcare Conference
Format: Corporate Presentation
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: January 11, 2024
Time: 12:00 p.m. PT
Location: Westin St. Francis,
A live webcast of the presentation will be available on the Events & Presentations section of the company’s website. A replay of the webcast will be archived for up to 30 days following the presentation date.
About SL-172154
SL-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 and patients with AML and HR-MDS.
About
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, the anticipated timing of additional data from Shattuck’s clinical trials, enrollment and potential expansion of the company’s clinical trials, the use of proceeds from the company’s recent financing transaction, and statements regarding Shattuck’s anticipated cash runway. 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 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
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:
Vice President of Investor Relations
InvestorRelations@shattucklabs.com
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