SL-325 / Shattuck - LARVOL DELTA

Shattuck’s lead product candidate, SL-325, is a potentially first-in-class DR3 antagonist antibody for the treatment of IBD and other inflammatory and immune-mediated diseases (Shattuck Labs Press Release) - "First participants dosed in the single-ascending dose (SAD) portion of the Phase 1 clinical trial in the third quarter of 2025; Enrollment of SAD and multiple-ascending dose (MAD) portions is expected to be completed in the second quarter of 2026; Safety, tolerability, DR3 occupancy, immunogenicity, and PK data will be evaluated in this open-label study, and Shattuck expects to disclose initial results by the second quarter of 2026."

P1 data • Trial status • Immunology

Shattuck Labs Announces Closing of up to $103 Million Private Placement… (GlobeNewswire) - "Aggregate net proceeds from private placement expected to fund SL-325 through multiple Phase 2 clinical trials, including in Inflammatory Bowel Disease (IBD) and potentially another autoimmune disease."

Financing • Inflammatory Bowel Disease

Shattuck Labs Announces IND for SL-325 Is in Effect for the Treatment of Inflammatory Bowel Disease (The Manila Times) - "Dosing of the first participant is expected this quarter, and enrollment of the Phase 1 clinical trial is expected to be completed in the second quarter of 2026."

IND • New P1 trial • Inflammatory Bowel Disease

Shattuck’s lead product candidate, SL-325, is a potentially first-in-class DR3 blocking antibody for the treatment of IBD and other inflammatory and immune-mediated diseases (GlobeNewswire) - "An IND was submitted to the FDA for SL-325 in July 2025; clearance expected in the third quarter of 2025...Phase 1 clinical trial will evaluate safety, tolerability, immunogenicity and pharmacokinetics in healthy volunteers, and determine the recommended Phase 2 dose and dosing schedule of SL-325. Subject to regulatory alignment, dosing of the first participant in the single-ascending dose (SAD) portion of the trial is expected in the third quarter of 2025, and the multiple-ascending dose (MAD) portion of the trial is expected to commence in the fourth quarter of 2025; Phase 1 enrollment of the SAD and MAD portions of the clinical trial is expected to be completed in the second quarter of 2026."

IND • New P1 trial • Immunology • Inflammation

Shattuck Labs Reports First Quarter 2025 Financial Results and Recent Business Highlights (GlobeNewswire) - "Phase 1 clinical trial will evaluate safety, tolerability, and pharmacokinetics, and determine the recommended Phase 2 dose and dosing schedule of SL-325. First patient in for the SAD portion of the trial expected in the third quarter of 2025. Phase 1 enrollment completion expected in the second quarter of 2026....Shattuck Labs to present at the PEGS Boston Summit on May 12, 2025...will present on SL-325 in the Advances in Immunotherapy section of the conference....Research and Development (R&D) Expenses: R&D expenses were $9.9 million for the quarter ended March 31, 2025, as compared to $16.3 million for the quarter ended March 31, 2024."

Clinical • Commercial • Enrollment status • New P1 trial • Inflammatory Bowel Disease

Shattuck Labs Announces Positive Data from the Preclinical GLP Toxicology Study of SL-325 at the 20th Congress of European Crohn’s and Colitis Organization (ECCO) in Inflammatory Bowel Diseases 2025 (GlobeNewswire) - "SL-325 is a high-affinity DR3 blocking antibody being developed for the treatment of inflammatory bowel disease (IBD); No evidence of toxicity or residual agonism observed in non-human primate toxicology study; SL-325 receptor occupancy (RO) and pharmacokinetic (PK) profile observed suggestive of extended dosing intervals; IND filing expected in the third quarter of 2025....We are excited for SL-325 to enter Phase 1 clinical trials later this year."

IND • New P1 trial • Preclinical • Inflammatory Bowel Disease

Pre-Clinical Development of SL-325, a High Affinity DR3 Blocking Antibody, for Durable Blockade of the DR3/TL1A Axis in Inflammatory Bowel Disease (ECCO-IBD 2025) - "Sequence equivalents of tulisokibart and RO7790121 were produced by transient transfection and affinity purification. No evidence of residual DR3 agonist activity was observed. Conclusion These results indicate SL-325 is a high-affinity DR3 blocking antibody with no evidence of toxicity or residual agonism in cynomolgus macaques, and with an RO/PK profile suggestive of extended dosing intervals that will be studied in an upcoming Phase 1 clinical trial."

Preclinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Shattuck Labs Announces Oral Presentation at Upcoming 20th Congress of European Crohn’s and Colitis Organization (ECCO) in Inflammatory Bowel Diseases 2025 (GlobeNewswire) - "Shattuck Labs...announced an upcoming oral presentation at the 20th Congress of ECCO in Inflammatory Bowel Diseases 2025 being held in Berlin, Germany from February 19–22, 2025. This presentation will feature results from the IND-enabling toxicology studies of SL-325, a first-in-class DR3 blocking antibody, in non-human primates."

Preclinical • Inflammatory Bowel Disease

DEVELOPMENT AND CHARACTERIZATION OF SL-325, A DR3-TARGETED, ANTAGONISTIC ANTIBODY FOR THE TREATMENT OF IBD (CCCongress 2025) - "Affinity of SL-325 to recombinant DR3 was determined to be 1.36 pM by SPR, while no binding was observed to DcR3, TNFR1 or TNFR2 by MSD. SL-325 bound to native cynomolgus DR3 with an EC50 that was comparable to human DR3 and no detectable binding was observed to other members of the TNF receptor family. SL-325 blocked recombinant TL1A binding to DR3 with an IC50 of 0.06 nM and 0.80 nM by MSD and FACS, respectively, which was equal to or better than the benchmark anti-TL1A mAbs."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • CD40 • IFNG • TNFA • TNFRSF1A • TNFRSF25

Shattuck Labs Announces Poster Presentation at Upcoming 2025 Crohn’s and Colitis Congress (GlobeNewswire) - "Shattuck Labs, Inc...today announced an upcoming poster presentation at the 2025 Crohn’s and Colitis Congress being held in San Francisco, California from February 6–8, 2025."

Clinical data • Inflammatory Bowel Disease

Shattuck Labs Provides Corporate Update and Highlights Upcoming Key Milestones in 2025 (GlobeNewswire) - "DR3 Program Milestones Expected in 2025: i) Preclinical SL-325 data readout from GLP toxicology study in NHPs expected in the first quarter of 2025. ii) IND filing for SL-325 expected in the third quarter of 2025. iii) SL-325 Phase 1 clinical trial initiation expected in the third quarter of 2025. iv) Nomination of lead DR3 bispecific development candidate(s) anticipated in the second half of 2025."

IND • New P1 trial • Pipeline update • Preclinical • Immunology • Inflammation

Shattuck Labs Reports Third Quarter 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "Announced development of SL-325, a first-in-class antagonist antibody to DR3, the receptor for TL1A; IND filing expected in Q3'2025..."

IND • Inflammatory Bowel Disease

Shattuck Labs Provides Company Update and Announces SL-325, a First-In-Class Death Receptor 3 (DR3) Antagonist Targeting the TL1A/DR3 Signaling Pathway (GlobeNewswire) - "Shattuck Labs, Inc...today announced a strategic pipeline prioritization....The Company will turn its focus to SL-325, its DR3 antagonist antibody, and plans initial clinical development in patients with IBD, where TL1A/DR3 blocking antibodies have demonstrated compelling monotherapy efficacy."

Pipeline update • Immunology • Inflammatory Bowel Disease