AUSTIN, TX & DURHAM, NC - Shattuck Labs, Inc. (NASDAQ:STTK), a clinical-stage biotechnology company, announced interim data from a Phase 1B trial showing encouraging response rates in HR-MDS and TP53m AML patients treated with its drug candidate SL-172154 in combination with azacitidine (AZA). The findings were presented at the European Hematology Association 2024 Congress on Friday.
The trial observed a 67% Objective Response Rate (ORR) in HR-MDS patients, with a 58% initial complete remission (CR)/marrow complete remission (mCR) rate. For TP53m AML patients, the ORR was 43%, with a 33% CR/complete remission with incomplete hematologic recovery (CRi) rate. Median overall survival for both groups has not been reached.
SL-172154, a bifunctional fusion protein targeting CD47 and CD40, is being developed as a potential new class of biologic medicine for cancer and autoimmune diseases. The drug demonstrated a manageable safety profile in combination with AZA, with no grade 3 or higher infusion-related reactions when premedicated with dexamethasone.
Shattuck's focus is now on HR-MDS and TP53m AML, indications with high unmet medical need and limited treatment options. Enrollment is underway in a randomized, controlled HR-MDS cohort, with regulatory discussions expected later this year.
Safety data as of April 23, 2024, revealed that grade 3/4 adverse events related to SL-172154 were reported in 42% of HR-MDS patients and 33% of TP53m AML patients. There were no deaths related to the treatment; however, there were treatment discontinuations due to adverse events.
The company also shared preliminary results from its trial in platinum-resistant ovarian cancer (PROC), where SL-172154 combined with other agents showed an acceptable safety profile but did not indicate additional clinical development plans in PROC due to the evolving competitive landscape.
Shattuck is set to concentrate its later-stage clinical development efforts on AML and HR-MDS, driven by the strength of the efficacy results and the potential for expedited approval paths.
This announcement is based on a press release statement from Shattuck Labs.
In other recent news, Shattuck Labs, a biotechnology firm, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its lead clinical candidate, SL-172154, aimed at treating acute myeloid leukemia (AML).
This designation is anticipated to accelerate the drug's development by offering various incentives, including seven years of market exclusivity upon potential FDA approval. Acute myeloid leukemia, a severe hematologic malignancy, is a pressing health concern, with the National Cancer Institute recording about 20,380 new cases and 11,310 deaths in the U.S. in 2023.
Shattuck Labs' SL-172154 is engineered to inhibit the CD47/SIRPα checkpoint interaction while activating the CD40 costimulatory receptor, potentially boosting the immune system's response against tumors. The company plans to present additional data from the Phase 1B dose expansion clinical trial of SL-172154, combined with azacitidine, at the European Hematology Association 2024 Congress.
FDA's orphan drug designation is granted to drugs that target conditions affecting fewer than 200,000 people in the United States, providing developers with incentives such as tax credits for clinical trials and waiver of application fees. Shattuck Labs is currently evaluating SL-172154 in multiple Phase 1 trials, including those for platinum-resistant ovarian cancer and AML.
InvestingPro Insights
As Shattuck Labs, Inc. (NASDAQ:STTK) showcases promising interim data from its clinical trials, the financial metrics and analyst insights from InvestingPro provide additional layers for investors to consider. Despite the clinical advancements, Shattuck Labs is navigating a challenging financial landscape. According to InvestingPro, the company holds a market capitalization of $325.25 million, reflecting its position in the biotech industry.
InvestingPro Tips highlight that Shattuck Labs' stock price has experienced significant volatility, and the stock has performed poorly over the last month with a 19.34% drop. Moreover, the company's gross profit margins have been weak, with a gross profit margin of -2611.12% for the last twelve months as of Q1 2024. However, it's worth noting the company's liquid assets exceed its short-term obligations, which may provide some financial stability in the near term.
Investors should also be aware of the company's valuation metrics, with a Price to Earnings (P/E) ratio of -3.63 and a Price to Book (P/B) ratio of 2.52 as of Q1 2024. These figures suggest that the market is valuing the company's future growth prospects cautiously, especially considering that analysts do not anticipate the company will be profitable this year. Additionally, with an RSI suggesting the stock is in oversold territory, there may be potential for a rebound if investor sentiment shifts following these clinical developments.
For those looking to delve deeper into Shattuck Labs' financial health and future prospects, InvestingPro offers a comprehensive suite of analytics and tips. There are 13 additional InvestingPro Tips available, which can guide investors to make more informed decisions. To access these insights, visit https://www.investing.com/pro/STTK and remember to use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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