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1250 articles, sorted by publication time.
The research team first used ProteinMPNN to improve enzyme stability, then applied continuous evolution to rewrite function; the resulting protease showed greater selectivity for ataxin-2, a protein associated with neurodegeneration, but the work currently remains an engineering validation at the cellular and in vitro levels.
A Phase III trial showed that sonesitatug vedotin can improve overall survival in patients with CLDN18.2-positive advanced gastric cancer; however, the full data have not yet been disclosed, and progression-free survival did not reach statistical significance.
deramiocel is set to undergo review by an expert committee, but the FDA has concluded that the pivotal trial failed to meet any prespecified efficacy endpoints; the developer counters that the dispute stems from the review’s use of an outdated draft analysis plan.
The research team combined protein structure models with evolutionary clues to create miniature RNA-guided nucleases not found in nature; some versions performed as well as natural proteins in bacterial, plant, and human cells, but increased activity may also be accompanied by more off-target editing.
The new algorithm seeks to provide more personalized interpretations for irregular cycles and noisier temperature data without reducing contraceptive effectiveness; however, publicly available information has yet to disclose the full validation size and subgroup results.
The all-cash transaction propels FB102, still in early-stage clinical development, onto the immunology M&A stage; argenx is acquiring not just a single indication, but a multi-disease strategy targeting pathogenic T cells and natural killer cells.
The FDA has cleared a first-in-human trial, allowing a therapy that uses gene editing to modify patients’ own regulatory T cells to enter testing in three types of metastatic cancer; the real test will be whether it can relieve tumor-induced immunosuppression without disrupting systemic immune balance.
Pathology-o3 learns “where to look first and why it matters” from pathologists’ zooming, panning, and dwell patterns, demonstrating high recall in tests of gastrointestinal cancer lymph node metastasis; however, its limited tasks and insufficient external data do not yet support routine diagnosis.
Preliminary results from a Phase 3 trial show that off-the-shelf immunotherapies simultaneously targeting BCMA and GPRC5D may move bispecific antibodies into earlier lines of treatment; however, median survival and detailed safety data have yet to be disclosed.
Researchers are adapting irreversible electroporation into a flexible catheter in an attempt to remove diseased cells from the bladder’s innermost layer and allow healthy tissue to regenerate. The NIH-supported project remains in preclinical development and will first use bladder-on-a-chip models built from patient cells to test safety and effectiveness.
The FDA considers the statistical evidence and magnitude of efficacy to be substantive review issues rather than procedural barriers to filing; Gossamer Bio has also regained worldwide rights, but whether the application is accepted for review and ultimately approved will still depend on an evaluation of the totality of the evidence.
Preliminary results from 18 evaluable patients show that adding locally delivered IL-12 gene therapy to chemotherapy and bevacizumab was associated with less microscopic residual disease and a higher circulating tumor DNA clearance rate; however, the sample is limited, and whether this can translate into delayed recurrence or longer survival remains to be answered by the complete trial and the Phase 3 study.