Alaunos Therapeutics Inc. (NASDAQ:TCRT) shares are down on Monday after the company announced preclinical proof-of-concept data for its lead drug candidate, ALN1003.
Data Results
The latest findings from Alaunos indicate that ALN1003 has shown promising results in diet-induced obesity mouse studies, with treated mice experiencing a mean percent change in body weight loss of up to -12.9%.
Peak reductions in absolute weight loss were observed by Day 13 and remained lower than DIO controls through Day 48.
In the first study, ALN1003 reduced liver weight compared to untreated mice by 43% and by 39% when expressed as a percentage of body weight.
Long-term administration of ALN1003 was associated with lower ALT (alanine aminotransferase; p<0.0001), AST (aspartate aminotransferase), and ALP (alkaline phosphatase), with a trend toward lower total bilirubin (nominal p=0.058) compared to untreated mice.
Additionally, the drug demonstrated favorable changes in metabolic biomarkers, including significant reductions in blood sugar and cholesterol levels.
In these studies, ALN1003 was well tolerated, with no severe adverse effects reported.
The company plans to pursue additional financing to support its ongoing preclinical work and initiatives related to chemistry, manufacturing, and controls.
Development Roadmap
Results from the two studies reinforce the company's strategy to advance additional preclinical and CMC work to optimize formulations while preserving therapeutic drug levels.
Planned next steps include studies to clarify ALN1003's mechanism, including blinded assessment of liver fat and MASLD severity.
The company also intends to refine manufacturing processes through an initial small-scale run followed by larger-scale production.
In parallel, a computational chemistry program is underway to develop and evaluate ALN1003 variants aimed at strengthening intellectual property and identifying next-generation candidates.
These efforts, alongside large animal pharmacokinetic studies, are expected to guide future IND-enabling activities.
TCRT Price Action: Alaunos Therapeutics shares were down 3.13% at $3.09 at the time of publication on Monday, according to Benzinga Pro data.
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