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Shattuck (STTK) Announces Positive Interim Data on Cancer Drug
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Shattuck Labs, Inc. (STTK - Free Report) announced updated interim data from the phase IB dose expansion study of lead candidate SL-172154, in combination with azacitidine, in frontline higher-risk myelodysplastic syndromes (HR-MDS) and TP53 mutant (TP53m) acute myeloid leukemia (AML) patients.
SL-172154 is an investigational agonist redirected checkpoint 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.
The latest data show that the rate of complete remission (CR) has improved since the last data release in December. These data are to be featured in a poster presentation during the European Hematology Association 2024 Congress.
In the HR MDS cohort, as of the data cut-off date of Apr 23, 2024, 21 out of the 24 patients treated had TP53m, 16 had complex karyotype and seven had therapy-related MDS. The objective response rate (ORR) was 67%. Ten patients achieved a CR with 3.6 months as the median time to CR, and nine are undergoing treatment. Three patients proceeded to allogeneic hematopoietic cell transplantation (HCT). All three patients achieved CR prior to HCT.
In the TP53m AML cohort, as of the data cut-off date of Jun 4, 2024, 21 of the treated patients had TP53 mutations or deletion, 19 had a complex karyotype and 14 had secondary AML. The ORR was 43%. Six patients achieved a CR. One patient achieved a complete remission with incomplete hematologic recovery and two a partial remission. The median time to CR was 3.8 months and none of the responders progressed as of the data cutoff. Five responders were taken to HCT and seven were still undergoing treatment.
SL-172154 demonstrated a manageable interim safety profile in combination with azacitidine. Infusion-related reactions (IRRs) were the most common SL-172154 treatment-emergent adverse events. Data showed the absence of G3 or higher IRRs when patients were premedicated with dexamethasone. There was no evidence of hemolytic (destructive) anemia.
Median overall survival and duration of remission have not yet been achieved. Enrollment is now underway for randomized, controlled expansion cohort in frontline HR-MDS patients.
Shattuck expects to engage in regulatory discussions later in the year regarding the registrational strategy for SL-172154.
Shares of this clinical clinical-stage biotechnology company have risen in pre-market trading following the results.
The company’s shares have lost 10.3% year to date compared with the industry's decline of 5.5%.
Image Source: Zacks Investment Research
Shattuck now focuses on clinical development opportunities in HR-MDS and TP53m AML indications, as these may offer the fastest route to potential approval.
The company is not currently planning to conduct additional clinical development of SL-172154 in platinum-resistant ovarian cancer due to the evolving competitive landscape in this indication.
Earlier in the week, Shattuck announced that the FDA has granted the orphan drug designation to SL-172154 for the treatment of AML.
The successful development of the candidate should be a significant boost for this clinical-stage company.
Zacks Rank & Other Stocks to Consider
Shattuck carries a Zacks Rank #2 (Buy) at present.
Some other top-ranked stocks in the biotech sector are Ligand Pharmaceuticals , ALX Oncology Holdings (ALXO - Free Report) and Minerva Neurosciences, Inc. (NERV - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy) at present, ALXO and NERV carry a Zacks Rank #2 each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share (EPS) has increased 16 cents to $4.71. During the same time frame, the consensus estimate for 2025 EPS has increased 70 cents to $5.90. Year to date, shares of LGND have risen 12.5%.
Ligand beat on earnings in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimate for 2025 has narrowed from $4.54 to $3.60.
NERV’s earnings beat estimates in one of the trailing four quarters and missed the same in the other three, the average negative surprise being 54.43%.
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Shattuck (STTK) Announces Positive Interim Data on Cancer Drug
Shattuck Labs, Inc. (STTK - Free Report) announced updated interim data from the phase IB dose expansion study of lead candidate SL-172154, in combination with azacitidine, in frontline higher-risk myelodysplastic syndromes (HR-MDS) and TP53 mutant (TP53m) acute myeloid leukemia (AML) patients.
SL-172154 is an investigational agonist redirected checkpoint 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.
The latest data show that the rate of complete remission (CR) has improved since the last data release in December. These data are to be featured in a poster presentation during the European Hematology Association 2024 Congress.
In the HR MDS cohort, as of the data cut-off date of Apr 23, 2024, 21 out of the 24 patients treated had TP53m, 16 had complex karyotype and seven had therapy-related MDS. The objective response rate (ORR) was 67%. Ten patients achieved a CR with 3.6 months as the median time to CR, and nine are undergoing treatment. Three patients proceeded to allogeneic hematopoietic cell transplantation (HCT). All three patients achieved CR prior to HCT.
In the TP53m AML cohort, as of the data cut-off date of Jun 4, 2024, 21 of the treated patients had TP53 mutations or deletion, 19 had a complex karyotype and 14 had secondary AML. The ORR was 43%. Six patients achieved a CR. One patient achieved a complete remission with incomplete hematologic recovery and two a partial remission. The median time to CR was 3.8 months and none of the responders progressed as of the data cutoff. Five responders were taken to HCT and seven were still undergoing treatment.
SL-172154 demonstrated a manageable interim safety profile in combination with azacitidine. Infusion-related reactions (IRRs) were the most common SL-172154 treatment-emergent adverse events. Data showed the absence of G3 or higher IRRs when patients were premedicated with dexamethasone. There was no evidence of hemolytic (destructive) anemia.
Median overall survival and duration of remission have not yet been achieved. Enrollment is now underway for randomized, controlled expansion cohort in frontline HR-MDS patients.
Shattuck expects to engage in regulatory discussions later in the year regarding the registrational strategy for SL-172154.
Shares of this clinical clinical-stage biotechnology company have risen in pre-market trading following the results.
The company’s shares have lost 10.3% year to date compared with the industry's decline of 5.5%.
Image Source: Zacks Investment Research
Shattuck now focuses on clinical development opportunities in HR-MDS and TP53m AML indications, as these may offer the fastest route to potential approval.
The company is not currently planning to conduct additional clinical development of SL-172154 in platinum-resistant ovarian cancer due to the evolving competitive landscape in this indication.
Earlier in the week, Shattuck announced that the FDA has granted the orphan drug designation to SL-172154 for the treatment of AML.
The successful development of the candidate should be a significant boost for this clinical-stage company.
Zacks Rank & Other Stocks to Consider
Shattuck carries a Zacks Rank #2 (Buy) at present.
Some other top-ranked stocks in the biotech sector are Ligand Pharmaceuticals , ALX Oncology Holdings (ALXO - Free Report) and Minerva Neurosciences, Inc. (NERV - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy) at present, ALXO and NERV carry a Zacks Rank #2 each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share (EPS) has increased 16 cents to $4.71. During the same time frame, the consensus estimate for 2025 EPS has increased 70 cents to $5.90. Year to date, shares of LGND have risen 12.5%.
Ligand beat on earnings in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimate for 2025 has narrowed from $4.54 to $3.60.
NERV’s earnings beat estimates in one of the trailing four quarters and missed the same in the other three, the average negative surprise being 54.43%.