XTALPI secures US Self-GRAS status for peptide Tensotide and early FDA IND nod for pan-TEAD inhibitor SIGX2649

Bulletin Express05-31

XtalPi Holdings Limited (XTALPI) reported two milestone achievements in its internal pipeline and incubated programs.

XTALPI’s in-house designed peptide ingredient Tensotide has obtained Self GRAS (Generally Recognized as Safe) certification in the United States. Developed via the company’s AI-driven PepiX™ discovery and optimisation platform, Tensotide targets carbohydrate energy-metabolism pathways, delivering four stated advantages: high activity, high stability across strong acid, alkali and enzyme conditions, high safety, and low-cost scalable production. The ingredient now holds regulatory qualification to enter the US food and dietary-supplement markets, extending XTALPI’s peptide commercialisation scope from topical to oral applications.

The company’s incubated vehicle, Signet Biotech, also received earlier-than-expected US FDA Investigational New Drug (IND) approval for SIGX2649, a potential first-/best-in-class pan-TEAD (TEAD1-4) inhibitor that blocks the Hippo-YAP/TAZ pathway to curb solid-tumour proliferation and drug resistance. Preclinical studies highlighted superior anti-proliferative activity across multiple tumour models, notable in vivo efficacy, favourable pharmacokinetics and reduced renal on-target toxicity relative to peer candidates. Core data are slated for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2026.

XTALPI stated that these developments validate the full-chain capabilities of its AI-enabled R&D platform and support its dual-track strategy in “Beauty and Health,” encompassing anti-aging cosmetic, lipid-lowering and uric-acid-lowering peptides alongside novel oncology therapeutics.

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