WASHINGTON UNIVERSITY SCHOOL OF MEDICINE

Vagus nerve stimulation therapy showed significant improvement in depressive symptoms, quality of life, and daily functioning for patients with treatment-resistant depression, according to a national clinical trial led by WashU Medicine. The study involved nearly 500 participants, with activated devices showing more time with improved symptoms and better quality of life. The therapy, if covered by CMS, could become more accessible.

WashU Medicine secured $683 million in NIH funding in 2024, a record high, affirming its leadership in shaping the future of medicine. The funding supports groundbreaking research and propels advancements in medical care, with WashU Medicine ranking No. 2 in NIH funding nationwide for the second consecutive year.

Coauthors from UC San Diego, Columbia University, GSK, Scripps Research, Harvard, and other institutions collaborated on a study funded by the Bill and Melinda Gates Foundation, NIH, and National Institute for General Medical Sciences. The authors declare no competing interests.

Tabelecleucel (tab-cel) showed 50.7% overall response rate (ORR) and 28.0% complete response (CR) rate in patients with EBV-associated PTLD after rituximab failure, with median time to response of 1.1 months and estimated duration of response of 23.0 months. The FDA is reviewing a biologics license application for tab-cel, with a target action date of January 15, 2025.

New AI can identify women at higher breast cancer risk by tracking changes in mammograms, detecting subtle differences not visible to the eye. The AI was trained on over 100,000 mammograms and identified high-risk women 2.3 times more accurately than standard methods. Researchers are now testing the AI on diverse racial and ethnic backgrounds.

Approximately 1.2 million people in the US live with HIV, 13% unaware. In 2022, 31,800 contracted HIV. Excision BioTherapeutics' EBT-101 CRISPR-based gene editing therapy met safety endpoints in a phase 1/2 trial, with one participant maintaining viral suppression for 16 weeks post-treatment. Novel gene editing approaches discussed at ASGCT 27th Annual Meeting include integrase-mediated programmable genomic integration and base editing for neurological disorders. AGT103-T gene therapy, blocking HIV-specific genes, showed promising efficacy signals in a phase 1 trial.

An early-stage clinical trial at Washington University School of Medicine in St. Louis found that adding itacitinib to standard care for stem cell transplant recipients may reduce graft-versus-host disease (GvHD), a life-threatening side effect. The trial, published in the Blood Journal, involved 42 patients with blood cancers who received itacitinib before and after transplantation. None developed severe GvHD, and overall survival at one year was 80%, higher than typical rates. Itacitinib, a JAK inhibitor, is under investigation for its potential to prevent GvHD before transplantation.

A clinical trial at WashU Medicine showed that adding itacitinib to standard care for 'half-matched' stem cell transplants may reduce graft-versus-host disease, with no severe cases observed in 42 patients.

Eisai and Biogen announce COFEPRIS approval of LEQEMBI® (lecanemab) for early Alzheimer’s disease, targeting soluble and insoluble Aβ aggregates. LEQEMBI is the first treatment shown to reduce disease progression and cognitive decline, already approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, the UAE, and Great Britain. The approval is based on the Phase 3 Clarity AD study, which met primary and secondary endpoints with significant results.

Eisai announced COFEPRIS approval of Leqembi (lecanemab) for early Alzheimer's disease in Mexico. Leqembi, developed by BioArctic and Eisai, targets amyloid-beta aggregates, reducing disease progression. It's also approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE, and Great Britain.