Tiziana Life Sciences Announces First Participants Dosed in ALS BANYAN Clinical Trial of Intranasal Foralumab

The first doses mark the start of participant treatment, but the ALS study has not reported safety or biomarker findings.

Rhea-AI Summary

Tiziana Life Sciences (TLSA) dosed the first three participants in its Phase 2a BANYAN trial of intranasal foralumab for ALS. The company-sponsored study, co-funded by the ALS Association, plans to enroll 44 people with early amyotrophic lateral sclerosis (ALS). Participants are assigned to foralumab or placebo at a 3:1 ratio for 12 weeks, followed by a 12-week active-treatment extension.

The primary endpoint is safety and tolerability. Other measures include regulatory T cells, immune gene expression, neurofilament light chain levels and brain imaging of microglial activation. Eligible participants must have had symptoms for no more than 24 months, slow vital capacity of at least 65% and neurofilament light chain of at least 40 pg/mL. The trial is underway in Boston, with additional sites planned in Chicago, Minneapolis and Davie, Florida. No BANYAN safety or biomarker results were reported.

Positive

• First three participants received intranasal foralumab in the Phase 2a ALS trial.
• ALS Association co-funding supports the company-sponsored BANYAN trial.

Negative

• Safety and biomarker results have not yet been reported from BANYAN.
• Eligibility is limited to early ALS with specified breathing-capacity and neurofilament thresholds.

Market Context

The Aug 24 BANYAN poster notice described the study as in operational startup, while this report mar...

Analysis

The Aug 24 BANYAN poster notice described the study as in operational startup, while this report marks dosing after that stage; its separate 0.88% reaction does not establish a response to today's milestone.

Key Figures

Participants dosed: 3 participants Study participants: 44 individuals Randomization: 3:1 (active drug : placebo) +1 more

Participants dosed

3 participants

First dose in the Phase 2a BANYAN trial

Study participants

44 individuals

Early ALS trial participants

Randomization

3:1 (active drug : placebo)

BANYAN trial design

Treatment periods

12-week randomized, controlled period; 12-week active extension

BANYAN trial duration

Previous Clinical trial Reports

1 past event · Latest: Aug 24

Same Type 1 event

1. Aug 24

   Trial poster presentation

   24h Move

   +0.9%

   Outlined BANYAN's Phase 2a design and biomarkers while the trial remained in operational startup.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

monoclonal antibody, neurofilament light chain, regulatory t cells, single-cell rna sequencing, +1 more

5 terms

monoclonal antibody medical

"a fully human, anti-CD3 monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

neurofilament light chain medical

"neurofilament light chain (NfL) ≥ 40 pg/mL"

Neurofilament light chain is a protein released into cerebrospinal fluid and blood when nerve cells are damaged, acting like a measurable “leak” that signals injury to the brain or spinal cord. For investors, it matters because rising or falling levels can serve as an objective readout in clinical trials and disease monitoring, helping assess whether a drug or therapy is slowing nerve damage and reducing development or commercial risk.

regulatory t cells medical

"regulatory T cells (Tregs) and T-cell subset profiling"

Regulatory T cells are a specialized type of immune cell that act like a brake on the body’s defense system, preventing it from attacking healthy tissue or causing chronic inflammation. They matter to investors because drugs that increase or block these cells can change treatment success and safety in areas such as autoimmune disease, organ transplants, and cancer immunotherapy, affecting clinical trial results, approval chances, and commercial value.

single-cell rna sequencing technical

"single-cell RNA sequencing of T-cell subpopulations"

A lab method that measures which genes are active inside individual cells, rather than averaging activity across a whole tissue; think of it as reading each person's text messages instead of a group chat. For investors, it matters because it helps drug developers and diagnostics companies identify precise targets, understand how treatments affect specific cell types, and find better patient groups, which can reduce development risk and influence the value of biomedical assets.

tspo-pet/mri technical

"brain TSPO-PET/MRI scans"

A TSPO-PET/MRI scan is a combined imaging test that overlays positron emission tomography (PET) targeting the translocator protein (TSPO) — a molecular marker that tends to rise where inflammation is present — onto detailed magnetic resonance images (MRI). Think of PET as a glowing spotlight showing where inflammatory activity is concentrated and MRI as the high-resolution map that locates it precisely; together they let researchers and clinicians see both the biological signal and the brain or body anatomy, which matters for diagnosing inflammatory conditions and measuring drug effects in clinical trials.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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BOSTON, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that the first three participants have all received their first dose of intranasal foralumab in the Phase 2a Healey ALS MyMatch BANYAN clinical trial.

The BANYAN Trial is evaluating intranasal foralumab in people living with amyotrophic lateral sclerosis (ALS). The study is sponsored by Tiziana Life Sciences and co-funded by the ALS Association through its Hoffman ALS Clinical Trial Awards Program. The trial is being conducted at the Healey & AMG Center (Boston, MA) and will be launched at The Les Turner ALS Center at Northwestern Medicine(Chicago, IL), University of Minnesota (Minneapolis, MN), and Nova Southeastern University (Davie, FL).

Trial Design

• Participants: 44 individuals with early ALS (≤ 24 months since symptom onset), slow vital capacity (SVC) ≥ 65%, and neurofilament light chain (NfL) ≥ 40 pg/mL.
• Randomization: 3:1 (active drug : placebo).
• Duration: 12-week randomized, controlled treatment period followed by a 12-week active extension treatment period.
• Primary Endpoint: Safety and tolerability of foralumab in patients with ALS.
• Secondary and Exploratory Endpoints:
  1. Immune reconstitution reflected by regulatory T cells (Tregs) and T-cell subset profiling.
  2. Immunologic gene expression assessed via single-cell RNA sequencing of T-cell subpopulations.
  3. Changes in neurofilament light chain (NfL) levels.
  4. Changes in microglial activation measured by brain TSPO-PET/MRI scans.

On October 1, at 5:00pm ET,  the Sean M. Healey & AMG Center for Integrated ALS Care and Discovery at Mass General Brigham will host a community webinar with Tiziana to discuss the science behind foralumab. Register for the webinar here.

The trial (ClinicalTrials.gov identifier: NCT07688239) is led by Suma Babu, MBBS, MPH, Principal Investigator of Healey ALS MyMatch and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Brigham, and James Berry, MD, MPH, Director of the Mass General Brigham Neuroscience Institute Clinical Trials Center for Neurotherapeutics, Chief of the Division of ALS and Motor Neuron Diseases, and Director of the NCRI.

“This study serves as a significant step in advancing the development of foralumab for ALS,” said Dr. Babu. “The BANYAN trial is designed to answer important questions about foralumab, specifically, whether it has a biological effect on Treg pathway in ALS, as measured by biomarkers.”

“Dosing the first participants in the BANYAN Trial is a meaningful milestone for Tiziana and for the ALS community,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “ALS is a devastating disease with urgent unmet medical need. Our intranasal foralumab represents a differentiated, non-invasive, and convenient approach designed to modulate neuroinflammation by inducing regulatory T cells that traffic to the central nervous system. We are deeply grateful for the partnership with the Healey & AMG Center, the ALS Association, the outstanding investigators, and trial sites, and most importantly, the people living with ALS and families who make this progress possible. We look forward to generating important biomarker and safety data that can help advance the field.”

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923), as well as additional Phase 2 trials in AD and MSA.

Intranasal foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About the Healey ALS MyMatch Program and BANYAN Trial:
Healey ALS MyMatch is reshaping ALS clinical research through biomarker-driven, personalized trial approaches. By integrating an emerging, comprehensive genetic and plasma biomarker pNFL, which was the basis of a recent accelerated approval for a genetic form of ALS, the program matches subgroups of individuals with ALS to experimental therapies based on their disease markers. The program consists of an ongoing series of early-phase clinical trials designed to deepen understanding of the biological effects of investigational products and to identify the optimal populations for future Phase 2/3 studies. Each trial in the program is named after a tree to symbolize hope and the deep scientific roots from which it grows, and careful thought went into designing the trial that balances scientific rigor with reducing participant and caregiver burden.

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

[1] https://www.pnas.org/doi/10.1073/pnas.2220272120

[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How many participants has Tiziana Life Sciences dosed in the BANYAN ALS trial?

Three participants have received their first dose of intranasal foralumab. BANYAN plans to enroll 44 people with early ALS.

What is the primary endpoint of Tiziana Life Sciences’ BANYAN ALS trial?

The primary endpoint is safety and tolerability of foralumab in people with ALS. The trial also measures immune-related and other biological markers; it has not reported results from those measures.