Tiziana Life Sciences Nasal Foralumab Phase 2 Clinical Trial Accepted into Healey ALS MyMatch Program

Rhea-AI Summary

Tiziana Life Sciences (Nasdaq: TLSA) announced on November 25, 2025 that its Phase 2 trial of intranasal foralumab in amyotrophic lateral sclerosis (ALS) was accepted into the Healey ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham.

The study, supported by a competitive grant from the ALS Association, will be led by Principal Investigators Suma Babu and James Berry and will enroll at multiple rapid-enrolling U.S. centers within the NEALS consortium. Successful investigational agents in MyMatch may advance to the HEALEY ALS Platform Trial or to standalone Phase 3 trials. The trial will use nasal immunology, blood and spinal fluid markers, cellular assays, and advanced brain imaging to evaluate foralumab’s effect on regulatory T cells and CNS inflammation.

Insights

Clinical development strategist

Acceptance into the Healey ALS MyMatch Program and an ALS Association grant mark a clear clinical-development milestone for intranasal foralumab.

Tiziana's Phase 2 intranasal foralumab will enroll at multiple rapid-enrolling U.S. NEALS sites and is now part of the Healey ALS MyMatch Program, backed by a competitive grant from the ALS Association. The program can route successful candidates into the HEALEY ALS Platform Trial or standalone Phase 3, creating a defined pathway for late‑stage evaluation.

Key dependencies and risks include timely site activation, patient enrollment at NEALS centers, and the upcoming biomarker and imaging readouts described for blood, spinal fluid, cellular, and brain imaging markers. The announcement cites preclinical and clinical evidence of a regulatory T‑cell mechanism in cervical lymph nodes migrating to the CNS, but offers no quantitative efficacy or safety data in humans.

Concrete items to watch: trial activation milestones and enrollment pace across NEALS sites, biomarker/imaging data collection and quality, and any future decision to move into the HEALEY ALS Platform Trial or a standalone Phase 3. Track these items over the next 6–24 months from Nov. 25, 2025.

BOSTON, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted for inclusion in the ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham.

The study, supported by a grant from the ALS Association, will be led by Principal Investigators Suma Babu, MBBS, MPH, and James Berry, MD, MPH, at Mass General Brigham. The trial will enroll at multiple rapid-enrolling U.S. centers within the Network of Excellence for ALS (NEALS) Consortium. Successful investigational products from the Healey ALS MyMatch program may advance to future regimens of the HEALEY ALS Platform Trial – a perpetual, multi-regimen, late-phase clinical efficacy study – or transition directly to standalone Phase 3 trials.

ALS is a serious neurodegenerative disease characterized by progressive motor neuron loss, leading to muscle weakness and paralysis. Neuroinflammation and immune dysregulation, particularly involving T-cell dysfunction and microglial activation, are increasingly recognized as key drivers of disease progression. Preclinical and clinical evidence indicate that nasally administered foralumab – a fully human anti-CD3 monoclonal antibody – stimulates regulatory T cells in cervical lymph nodes, which then migrate to the central nervous system to suppress pathogenic inflammation and restore microglial homeostasis.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, stated: “The rapid progression to trial activation reflects the urgency of the ALS community and the compelling science behind nasal foralumab. By leveraging the immune-modulatory potential of the nasal route, we aim to deliver meaningful clinical impact with a non-invasive therapy. We are deeply grateful to the ALS Association for their partnership and to the NEALS Consortium for their operational excellence. Foralumab’s ability to expand regulatory T cells and dampen CNS inflammation offers a biologically rational approach to slowing progression in a genetically defined ALS population. We are eager to translate these mechanisms into patient benefit.”

Suma Babu, MBBS, MPH, Principal Investigator of the ALS MyMatch program and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Brigham, added: “This innovative multi-site randomized placebo-controlled trial will integrate innovative nasal immunology with cutting-edge blood, spinal fluid and cellular and advanced brain imaging markers to understand the effect of the drug.”

A competitive grant has been awarded to Tiziana Life Sciences towards funding this study following rigorous peer review by the ALS Association.

About ALS MyMatch

ALS MyMatch is a multi-site, collaborative initiative that currently brings together four trial-ready, high enrolling ALS research centers and is a Network of Excellence for ALS (NEALS) affiliated program. Research centers include Mass General in Boston; University of Minnesota in Minneapolis, Minn.; Northwestern University in Evanston, Ill.; and Nova Southeastern University in Fort Lauderdale, Fla. ALS MyMatch has partnered with the Acceleration Centers of Enrollment (ACE) program, a community-driven philanthropic partnership program focused on expediting start up and recruitment at study centers. Additional trials and high performing sites will be added as the program grows. Organizations can apply on the ALS MyMatch website.

About the Sean M. Healey & AMG Center for ALS at Mass General Brigham

At the Sean M. Healey & AMG Center for ALS at Mass General Brigham, we are committed to bringing together a global network of scientists, physicians, nurses, foundations, federal agencies, and people living with ALS, their loved ones, and caregivers to accelerate the pace of ALS therapy discovery and development.
Launched in November 2018, the Healey & AMG Center, under the leadership of Merit Cudkowicz, MD and a Science Advisory Council of international experts, is reimagining how to develop and test the most promising therapies to treat the disease, identify cures and ultimately prevent it.

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).

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 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 nasal 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

What did Tiziana Life Sciences (TLSA) announce on November 25, 2025 about foralumab in ALS?

TLSA announced its Phase 2 intranasal foralumab trial was accepted into the Healey ALS MyMatch Program and received a competitive grant from the ALS Association.

Who will lead the TLSA Phase 2 nasal foralumab trial included in the Healey ALS MyMatch Program?

The trial will be led by Principal Investigators Suma Babu, MBBS, MPH and James Berry, MD, MPH at Mass General Brigham.

How will the TLSA Phase 2 foralumab study recruit patients and where will it run?

The study will enroll at multiple rapid-enrolling U.S. centers within the NEALS Consortium.

What assessments will the TLSA nasal foralumab Phase 2 trial use to measure effect?

The trial will integrate nasal immunology with blood and spinal fluid markers, cellular assays, and advanced brain imaging markers.

What are potential next steps if TLSA’s foralumab is successful in the MyMatch Program?

Successful investigational products may advance to the HEALEY ALS Platform Trial or transition directly to standalone Phase 3 trials.

What is the proposed biological mechanism for intranasal foralumab in ALS according to TLSA?

Foralumab is described as expanding regulatory T cells in cervical lymph nodes that migrate to the CNS to suppress pathogenic inflammation and restore microglial homeostasis.