BOSTON, Mass. — September 28, 2026

Tiziana Life Sciences, Ltd. announced that the first three participants have been dosed in the Phase 2a Healey ALS MyMatch BANYAN clinical trial evaluating intranasal foralumab in people living with amyotrophic lateral sclerosis (ALS). The trial is sponsored by Tiziana and co-funded by the ALS Association through its Hoffman ALS Clinical Trial Awards Program, with the study being conducted initially at the Sean M. Healey & AMG Center for ALS at Mass General Brigham and planned to expand to additional sites in Chicago, Minneapolis and Davie, Florida. BANYAN is designed to evaluate the safety and tolerability of intranasal foralumab while also examining biological markers associated with immune regulation and neuroinflammation. The first dosing milestone marks the beginning of clinical evaluation of the investigational therapy in an ALS population and will generate early safety and biomarker data

BANYAN Trial Evaluates Intranasal Foralumab in ALS

The Phase 2a BANYAN study is planned to enroll 44 participants with early ALS, defined as no more than 24 months since symptom onset, with slow vital capacity of at least 65% and neurofilament light chain (NfL) levels of at least 40 pg/mL. Participants will be randomized 3:1 to intranasal foralumab or placebo during a 12-week controlled treatment period, followed by a 12-week active extension. The primary endpoint is safety and tolerability, while secondary and exploratory assessments will examine regulatory T cells (Tregs), T-cell subsets, immune-related gene expression, NfL levels and microglial activation. Single-cell RNA sequencing will be used to evaluate gene-expression changes in selected T-cell populations, while TSPO-PET/MRI imaging will assess changes in brain microglial activation. The trial is registered as NCT07688239 and is being led by investigators from Mass General Brigham.

Foralumab Targets Neuroinflammatory Pathways

Foralumab is an investigational fully human anti-CD3 monoclonal antibody administered through the intranasal route, with Tiziana developing the therapy as an immunomodulatory approach for neuroinflammatory and neurodegenerative diseases. The company states that intranasal administration has been shown to stimulate regulatory T cells, which may influence immune activity within the central nervous system. In the BANYAN trial, researchers will specifically assess whether treatment produces measurable biological effects in the Treg pathway and associated biomarkers in people with ALS. Foralumab is also being evaluated in other neurological and neuroinflammatory conditions, including non-active secondary progressive multiple sclerosis, Alzheimer’s disease and multiple system atrophy. Earlier observations cited by Tiziana include an Expanded Access Program in 14 patients with non-active secondary progressive multiple sclerosis, but those open-label observations are not controlled evidence of efficacy.

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Tiziana Expands Foralumab Clinical Development

The BANYAN trial expands Tiziana’s clinical development of intranasal foralumab into ALS, adding a biomarker-driven study to the company’s broader immunomodulation program. The Healey ALS MyMatch initiative uses clinical and biological characteristics to support early-phase studies designed to investigate the biological effects of experimental therapies and identify populations for future development. Tiziana said the BANYAN study is intended to provide information on safety, immune reconstitution and potential biological effects rather than establish clinical efficacy. A community webinar hosted by the Sean M. Healey & AMG Center for Integrated ALS Care and Discovery is scheduled for October 1, 2026, to discuss the science behind foralumab. As the trial progresses, safety findings and biomarker changes will provide early clinical information to guide further investigation of intranasal foralumab in ALS.

Source Tiziana Life Sciences, press release