Tiziana Life Sciences Announces Groundbreaking ALS Trial Grant Awarded by the ALS Association
Tiziana Life Sciences (NASDAQ: TLSA) has received a grant from the ALS Association through the Hoffman ALS Clinical Trial Awards Program to fund a 20-patient clinical trial of intranasal foralumab, their lead development candidate. The trial will evaluate safety and early-stage disease improvement parameters in ALS patients. Foralumab, a fully human anti-CD3 monoclonal antibody, has shown promise in treating Multiple Sclerosis, with positive results in 10 patients under an Expanded Access Program. The FDA has approved enrollment of 20 additional patients in this program.
Tiziana Life Sciences (NASDAQ: TLSA) ha ricevuto un finanziamento dall'ALS Association attraverso il programma Hoffman ALS Clinical Trial Awards per finanziare uno studio clinico su 20 pazienti con foralumab intranasale, il loro candidato principale in fase di sviluppo. Lo studio valuterà la sicurezza e i parametri di miglioramento della malattia nelle fasi iniziali nei pazienti affetti da SLA. Foralumab, un anticorpo monoclonale anti-CD3 completamente umano, ha mostrato promesse nel trattamento della sclerosi multipla, con risultati positivi in 10 pazienti sotto un programma di accesso espanso. La FDA ha approvato l'arruolamento di 20 ulteriori pazienti in questo programma.
Tiziana Life Sciences (NASDAQ: TLSA) ha recibido una subvención de la ALS Association a través del programa Hoffman ALS Clinical Trial Awards para financiar un ensayo clínico de foralumab intranasal en 20 pacientes, su principal candidato en desarrollo. El ensayo evaluará la seguridad y los parámetros de mejora de la enfermedad en las etapas iniciales en pacientes con ELA. Foralumab, un anticuerpo monoclonal anti-CD3 completamente humano, ha mostrado promesas en el tratamiento de la esclerosis múltiple, con resultados positivos en 10 pacientes bajo un programa de acceso expandido. La FDA ha aprobado la inclusión de 20 pacientes adicionales en este programa.
티지아나 라이프 사이언스 (NASDAQ: TLSA)는 호프만 ALS 임상 시험 상 프로그램을 통해 ALS 협회로부터 보조금을 받았습니다. 이 보조금은 그들의 주요 개발 후보인 비강용 포랄루맙에 대한 20명의 환자를 대상으로 한 임상 시험을 지원하는 것입니다. 이 시험은 ALS 환자에서 안전성과 초기 단계의 질병 개선 매개변수를 평가할 것입니다. 포랄루맙은 완전히 인간화된 항-CD3 단클론 항체로, 10명의 환자에게서 긍정적인 결과를 보여주며 다발성 경화증 치료에 대한 가능성을 보였습니다. FDA는 이 프로그램에 20명의 추가 환자 등록을 승인했습니다.
Tiziana Life Sciences (NASDAQ: TLSA) a reçu une subvention de l'ALS Association par le biais du programme Hoffman ALS Clinical Trial Awards pour financer un essai clinique de foralumab intranasal sur 20 patients, leur principal candidat en développement. L'essai évaluera la sécurité et les paramètres d'amélioration de la maladie à un stade précoce chez les patients atteints de SLA. Foralumab, un anticorps monoclonal anti-CD3 entièrement humain, a montré des promesses dans le traitement de la sclérose en plaques, avec des résultats positifs chez 10 patients dans le cadre d'un programme d'accès élargi. La FDA a approuvé l'inscription de 20 patients supplémentaires dans ce programme.
Tiziana Life Sciences (NASDAQ: TLSA) hat von der ALS Association einen Zuschuss über das Hoffman ALS Clinical Trial Awards Program erhalten, um eine klinische Studie mit 20 Patienten zu finanzieren, die intranasalen Foralumab testen, ihren Hauptentwicklungskandidaten. Die Studie wird die Sicherheit und die Parameter der frühen Verbesserung der Krankheit bei ALS-Patienten bewerten. Foralumab, ein vollständig menschlicher anti-CD3 monoklonaler Antikörper, hat bei der Behandlung von Multipler Sklerose vielversprechende Ergebnisse gezeigt, mit positiven Ergebnissen bei 10 Patienten im Rahmen eines erweiterten Zugangsprogramms. Die FDA hat die Aufnahme von 20 weiteren Patienten in dieses Programm genehmigt.
- Received grant funding from ALS Association for clinical trial
- FDA approved expansion of Expanded Access Program from 10 to 30 patients for Multiple Sclerosis treatment
- Positive early results in Multiple Sclerosis patients showing disease improvement or stability within 6 months
- None.
Insights
This grant approval from the ALS Association marks a significant milestone for Tiziana's intranasal foralumab development program. The funding will support a 20-patient clinical trial targeting ALS, representing a strategic expansion beyond their current multiple sclerosis focus. The trial's design, incorporating PET imaging for neuroinflammation monitoring, mirrors their successful MS program approach.
The existing data from their MS expanded access program, showing improvement or disease stability in all 10 patients within 6 months, provides encouraging preliminary validation of foralumab's mechanism. The FDA's recent approval to expand this program to 20 additional MS patients further strengthens the drug's potential.
While promising, investors should note this is an early-stage trial focused on safety and preliminary efficacy signals. The ALS market represents a significant opportunity with treatment options, but development risks remain high at this phase.
This development expands Tiziana's potential market opportunity significantly. The ALS therapeutic market, while smaller than MS, represents a critical unmet need with competition. The grant provides non-dilutive funding and validates the technology platform, potentially increasing partnership opportunities.
The backing from prestigious institutions like Mass General Hospital and the ALS Association enhances credibility for future funding rounds or partnerships. For a company with a
The parallel development in both MS and ALS demonstrates platform potential in neurological conditions, which could attract larger pharmaceutical companies interested in CNS therapeutics.
NEW YORK, Nov. 19, 2024 (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 its grant application to the ALS Association has been approved for funding. The grant is awarded as part of the Hoffman ALS Clinical Trial Awards Program and is titled “Modulation of ALS neuroinflammation by nasal anti-CD3 monoclonal Antibody”. The Association’s grant will fund a 20-patient clinical trial of two doses of Tiziana’s novel and patented therapeutic candidate, intranasal foralumab, aimed at evaluating the safety and early-stage parameters of disease improvement in Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease.
ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord, ultimately leading to muscle weakness and paralysis. ALS is an orphan disease, but its clinical course can be rapid with marked disability even at an early stage. Over the course of the disease, people lose the ability to move, to speak, and eventually, to breathe. The disease is always fatal, usually within five years of diagnosis. Few treatment options exist, resulting in a high unmet need for new therapies to address functional deficits and disease progression.
“The Hoffman ALS Clinical Trial Awards Program supports early-stage clinical trials of potential new therapies that hold promise for those living with ALS,” said Kuldip Dave, Ph.D., Senior Vice President of Research at the ALS Association. “With this award, we are pleased to help advance the development of intranasal foralumab for ALS. By funding programs at this early stage, we hope to accelerate the development of therapeutic candidates that can help make ALS a livable disease.”
James Berry, MD, MPH, and Suma Babu, MBBS, MS, the Director and Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Hospital, a founding member of Mass General Brigham, commented: “We are incredibly grateful to the ALS Association for recognizing the promise of intranasal foralumab, and we are excited to initiate clinical development in ALS in hopes of identifying a novel therapy for ALS and other neurodegenerative diseases. We will be using PET imaging to detect neuro inflammation in this study of patients with ALS. We hope to replicate the previous positive findings of the PET imaging approach that Tiziana has seen in studies of patients with multiple sclerosis, in this new potential indication for intranasal foralumab.”
"We are honoured to receive this prestigious grant from the ALS Association, which underscores the promising potential of our therapeutic platform in addressing the urgent needs of ALS patients. This funding will accelerate our clinical development efforts and bring us closer to potentially transformative treatment options for ALS,” said Ivor Elrifi, CEO of Tiziana Life Sciences. "Tiziana Life Sciences’ innovative approach targets the underlying mechanisms of ALS with the aim of halting or slowing disease progression. The company’s commitment to rigorous scientific research and patient-centric innovation aligns with the ALS Association’s mission to discover treatments and a cure for ALS, as well as to serve, advocate for, and empower people affected by ALS.”
The Hoffman ALS Clinical Trial Awards Program, named in honor of the late philanthropist Hugh Hoffman, helps develop new and improved ALS therapies by supporting early-stage clinical trials. These trials produce data on safety, dosing, and biomarkers that are essential for advancing an investigational therapy one step closer to being evaluated by the FDA. Positive results at this stage also “de-risk” the next stage of drug development, typically large clinical trials, and help attract the follow-on funding necessary to complete this work.
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, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. 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).
About the ALS Association
The ALS Association is the largest philanthropic funder of ALS research in the world. The Association funds global research collaborations, assists people with ALS and their families through its nationwide network of care and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association is working to make ALS a liveable disease while urgently searching for new treatments and a cure. For more information about the ALS Association, visit our website at www.als.org
About the Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than
About Foralumab
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for 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, 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 is the purpose of Tiziana Life Sciences' (TLSA) ALS Association grant?
How many patients are currently being treated with Tiziana's (TLSA) foralumab for Multiple Sclerosis?
What are the current results of Tiziana's (TLSA) foralumab treatment in Multiple Sclerosis patients?
