Trial Watch – Jan Edition 1

Processa completed enrollment of the 20th patient for an interim analysis in its Phase 2 trial comparing NGC-Cap with capecitabine alone in advanced or metastatic breast cancer. The analysis will assess safety, preliminary efficacy and dose optimization for the remainder of the study.

On Jan 6, 2026, the FDA cleared a new Phase 2 study of oral (Z)-endoxifen in metastatic ER positive HER2 negative breast cancer. The study follows encouraging results from the EVANGELINE trial and will evaluate dosing and comparative outcomes.

A Phase 1 trial showed immune responses in 74 percent of participants with favorable safety in a preventive vaccine targeting α-lactalbumin in triple-negative breast cancer. A Phase 2 study is planned to evaluate efficacy.

Olema announced Phase 1 development of OP-3136, an oral KAT6 inhibitor targeting epigenetic drivers of hormone-dependent breast cancer. The study will evaluate safety, pharmacokinetics and early efficacy signals.

A Phase 1 study dosed its first patient with ART-101, a PSMA-targeted radioligand for metastatic castration-resistant prostate cancer. The trial will assess safety, biodistribution and imaging.

Neumora reported reductions in agitation scores in a Phase 1b study of NMRA-511 in Alzheimer's disease. A multiple-ascending-dose extension is ongoing, with Phase 2 and 3 development planned.

The FDA granted Fast Track designation for ML-007C-MA in Alzheimer's disease psychosis. The Phase 2 VISTA trial is enrolling approximately 300 participants following favorable Phase 1 safety data.

Denali announced regulatory clearance to begin first-in-human studies of DNL628, an OTV-enabled anti-tau antibody. A Phase 1b study for DNL921 is expected in the first half of 2026.

Annovis initiated a long-term open-label extension study enrolling approximately 500 patients to evaluate safety and biomarkers over up to 36 months.

Gain reported biomarker improvements in a Phase 1b study of GT-02287, including reductions in disease-associated glycolipids. Next-stage development planning is underway.

The TUPELO trial showed rapid and durable reductions in polyp burden in familial adenomatous polyposis. Recursion plans FDA engagement in the first half of 2026 to discuss registrational pathways.