This section highlights FDA-related milestones and regulatory updates for drugs developed by Shattuck Labs (STTK).
Over the past two years, Shattuck Labs has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SL-172154, SL-172154, and SL-325. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SL-172154 - FDA Regulatory Timeline and Events
SL-172154 is a drug developed by Shattuck Labs for the following indication: For the treatment of AML.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SL-172154
- Announced Date:
- October 1, 2024
- Indication:
- For the treatment of AML
Announcement
Shattuck Labs, Inc announced a strategic pipeline prioritization to include the discontinuation of its clinical program, SL-172154.
AI Summary
Shattuck Labs, Inc. has decided to discontinue its clinical program for SL-172154 after interim data showed only modest improvements in overall survival for patients with TP53 mutant AML and higher-risk MDS. The results did not meet the expectation of a clear clinical benefit when SL-172154 was combined with azacitidine. In response, the company is shifting its focus to SL-325, a first-in-class DR3 antagonist antibody. SL-325 is designed to block the TL1A/DR3 signaling pathway and is planned for clinical development in patients with inflammatory bowel disease. Shattuck expects to file an IND for SL-325 in the third quarter of 2025. Additionally, the company announced a restructuring that will reduce its workforce by about 40%, optimizing resources and extending its cash runway into 2027, positioning Shattuck for future success.
Read Announcement- Drug:
- SL-172154
- Announced Date:
- June 10, 2024
- Indication:
- For the treatment of AML
Announcement
Shattuck Labs, Inc announced that the U.S. FDA has granted orphan drug designation (ODD) to lead clinical candidate SL-172154 for the treatment of AML.
AI Summary
Shattuck Labs, Inc. announced that the U.S. FDA has granted orphan drug designation (ODD) to its lead clinical candidate, SL-172154, for treating acute myeloid leukemia (AML). The designation is important because it supports the development of new therapies for AML, a disease with few treatment options and a poor outlook for patients. With orphan drug status, SL-172154 may get benefits such as market exclusivity for seven years after FDA approval, tax credits for clinical trials, and fee waivers.
This milestone underlines the urgency in finding better treatments for AML, especially for patients with limited alternatives. Shattuck Labs is encouraged by the decision and plans to move SL-172154 into later-stage clinical studies to further explore its effectiveness and potential as a breakthrough treatment option.
Read Announcement
SL-172154 (AML HR-MDS) - FDA Regulatory Timeline and Events
SL-172154 (AML HR-MDS) is a drug developed by Shattuck Labs for the following indication: Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SL-172154 (AML HR-MDS)
- Announced Date:
- June 14, 2024
- Estimated Event Date Range:
- June 14, 2024 - June 14, 2024
- Target Action Date:
- June 14, 2024
- Indication:
- Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS)
Announcement
Shattuck to host conference call and webcast today, June 14, 2024 at 7:30 a.m. ET
AI Summary
Shattuck Labs, a clinical-stage biotech company developing innovative fusion proteins for cancer and autoimmune diseases, announced positive interim data from its Phase 1B trial of SL-172154 in combination with azacitidine for frontline HR-MDS and TP53 mutant AML patients. Encouraging efficacy and a manageable safety profile were reported, with notable objective response rates in both indications. As part of its effort to update investors and the medical community, Shattuck will host a conference call and live webcast today, June 14, 2024, at 7:30 a.m. ET. The call will feature lead investigator Dr. Naval Daver from the MD Anderson Cancer Center and will cover details from the poster presentation at the EHA 2024 Congress. Interested participants can register and listen in via the Shattuck Labs Investor Relations webpage.
Read Announcement- Drug:
- SL-172154 (AML HR-MDS)
- Announced Date:
- June 14, 2024
- Indication:
- Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS)
Announcement
Shattuck Labs 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.
AI Summary
Shattuck Labs announced updated interim results from its Phase 1B dose expansion trial of SL-172154 combined with AZA in patients with frontline high-risk myelodysplastic syndromes (HR-MDS) and TP53-mutated acute myeloid leukemia (AML). In the HR-MDS group, 67% of patients achieved an objective response, with a complete remission or marrow complete remission rate of 58%. In the TP53m AML cohort, 43% of patients showed an objective response, including 33% who reached complete remission or partial hematologic recovery. These encouraging results support the potential of SL-172154’s unique dual mechanism of blocking the CD47 checkpoint and activating CD40. The safety profile remains manageable, with premedication helping reduce infusion-related reactions. Shattuck Labs is focusing its clinical development on these high unmet need areas and is continuing to enroll patients in a randomized, controlled cohort for HR-MDS, with future regulatory discussions planned later this year.
Read Announcement
SL-325 - FDA Regulatory Timeline and Events
SL-325 is a drug developed by Shattuck Labs for the following indication: In inflammatory bowel disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SL-325
- Announced Date:
- February 20, 2025
- Indication:
- In inflammatory bowel disease
Announcement
Shattuck Labs announced positive preclinical data from an IND-enabling GLP toxicology study of SL-325 in non-human primates (NHP).
AI Summary
Shattuck Labs announced positive preclinical data from a GLP toxicology study of SL-325 in non-human primates. SL-325 is a high-affinity DR3 blocking antibody designed to treat inflammatory bowel disease. In the study, conducted in cynomolgus macaques, the drug was given in three doses and showed no evidence of toxicity or residual agonism. The research confirmed that SL-325 achieved full and durable receptor occupancy at low doses, with no sign of unwanted immune cell activation, such as CD4 or CD8 T cell stimulation. These findings suggest that the antibody has a favorable pharmacokinetic profile, which may allow for extended dosing intervals in future treatments.
The promising results support plans to file an IND by the third quarter of 2025 and to soon begin Phase 1 clinical trials. This marks an important step forward in the development of new treatments for inflammatory bowel disease, highlighting the potential for SL-325 to offer effective and durable therapy for patients.
Read Announcement- Drug:
- SL-325
- Announced Date:
- October 1, 2024
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 - 2025
- Indication:
- In inflammatory bowel disease
Announcement
Shattuck Labs, announced that Prioritization to focus on SL-325, a first-in-class antagonist antibody to DR3, the receptor for TL1A, intended for clinical development in inflammatory bowel disease (IBD); IND filing expected in Q3 2025
AI Summary
Shattuck Labs has announced a strategic switch in its focus, concentrating now on SL-325 rather than its previous candidate. SL-325 is a first-in-class DR3 antagonist antibody that directly targets the TL1A/DR3 signaling pathway. The company believes that a more complete blockade of this pathway could offer a stronger treatment option for inflammatory bowel disease (IBD) compared to current treatments that only block TL1A. Shattuck Labs plans to start clinical development of SL-325 targeting patients with IBD, and they expect to file an Investigational New Drug (IND) application in the third quarter of 2025.
This new focus reflects a shift towards opportunities with a higher likelihood of success, as the previous candidate did not show enough improvement in patient survival. The move also aligns with ongoing plans to optimize resources and restructure the company for long-term progress.
Read Announcement
