FDA Fast Track Designation (FTD) aims to accelerate the review process of high-value assets, and ISM6331 marks Insilico’s first FTD, recognizing the clinical potential in advanced mesothelioma.

ISM6331 is a novel, potential best-in-class, pan-TEAD inhibitor engineered via Chemistry42 to restore Hippo pathway balance, and its Phase I first-in-human data has been accepted for a brief oral presentation at ESMO 2026.

The FTD grants ISM6331 enhanced FDA engagement to accelerate the clinical development processes, alongside eligibility for Rolling Review, Accelerated Approval, and Priority Review, if relevant criteria are met.

Researchers have discovered that smooth septate junction proteins regulate intestinal stem cell proliferation by removing aPKC from the apical cortex of differentiating progenitor cells in the Drosophila intestine. This process preserves the Kibra activity and prevents excessive growth-promoting signaling. The findings uncover an unexpected signaling function for cell-cell adhesion proteins in maintaining tissue homeostasis and provide new insights into mechanisms that may be relevant to tissue regeneration and cancer development in higher organisms.

EMBL and collaborators developed ‘spatialproteomics’, an open-source software that helps researchers analyse complex tissue images and understand how cells are organised within tumours. The tool streamlines a workflow that was previously fragmented, taking users from raw microscopy images through cell segmentation, annotation, and spatial analysis, to biological insight in one unified framework. In studies of B-cell non-Hodgkin lymphoma, the software revealed distinct spatial patterns in tumour and immune cells that helped distinguish between slow-growing and aggressive samples. Spatialproteomics could be useful in studies across many cancers, inflammatory diseases, and in tissues where spatial organisation matters.