Shattuck Labs Inc unveiled promising topline dose-expansion data from its Phase 1A/B trial of SL-172154 in combination with Azacitidine (AZA) for the treatment of frontline high-risk myelodysplastic syndromes (HR-MDS) and TP53 mutant (TP53m) acute myeloid leukemia (AML) patients. The announcement sparked a substantial surge in the stock of Shattuck Labs, which closed Tuesday’s trading at $2.11 and began trading Wednesday morning at $4.38.
At the time of this publication, Shattuck Labs Inc stock (STTK) has witnessed a surge.
Shattuck Labs Inc
Current Price: $3.96
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The study, which focused on evaluating the efficacy and safety of the drug combination, revealed an encouraging Objective Response Rate (ORR) of 79% in frontline HR-MDS patients, primarily those with TP53 mutations. Notably, an initial complete response (CR)/marrow complete response (mCR) rate of 64% was observed.
In the frontline TP53m AML patient group, the study recorded a 27% initial CR/complete response with incomplete hematologic recovery (CRi). Among the 11 evaluable patients, 5 achieved stable disease with decreasing blast counts and improvements in peripheral blood counts.
For HR-MDS patients, specifically those with previously untreated HR-MDS and TP53 mutations or deletion, the data demonstrated promising outcomes. Out of 14 evaluable patients, 5 achieved a CR, 4 achieved a mCR (3 with hematologic improvement in at least one lineage), and 2 achieved stable disease (both with hematologic improvement in at least one lineage).
In the TP53m AML cohort, comprising 11 evaluable patients with previously untreated TP53m AML, 2 achieved a CR, and another patient achieved a CRi, subsequently undergoing allogeneic hematopoietic cell transplantation (allo-HCT). Additionally, seven subjects with stable disease experienced blast reductions, with five showing recovery of platelets or neutrophils and remaining on the study, indicating the potential for further improvement. Unfortunately, one subject succumbed during the first treatment cycle.
Preliminary safety data suggested that the combination of SL-172154 and azacitidine had an acceptable safety and tolerability profile. The study also noted early signals of activity, including rapid blast count reductions observed in 100% of frontline TP53m AML patients who underwent an on-treatment bone marrow biopsy.
In the HR-MDS cohort, most patients exhibited blast count reductions and hematologic improvement early in the treatment course, emphasizing the positive impact of the SL-172154 and AZA combination.
The company’s announcement marks a significant milestone in the development of new therapeutic options for high-risk myelodysplastic syndromes and TP53 mutant acute myeloid leukemia. The positive results have not only generated excitement among investors but also instilled hope for improved treatment outcomes for patients facing these challenging hematologic conditions. Shattuck Labs Inc. remains committed to advancing its innovative therapies and contributing to the advancement of cancer treatment.
