Tiziana Life Sciences Submits Grant Application to ALS Association to Fund Clinical Trial of Intranasal Foralumab
Tiziana Life Sciences (Nasdaq: TLSA), a biotechnology company, has applied for a grant from the ALS Association to fund a clinical trial for intranasal foralumab, an anti-CD3 monoclonal antibody. The grant is part of the Hoffman ALS Clinical Trial Awards Program. The trial aims to evaluate the safety, dosing, and biomarkers of foralumab in ALS patients using cutting-edge imaging techniques like PET scans. Previously, foralumab showed promising results in an Expanded Access Program for non-active secondary progressive multiple sclerosis. The company hopes the grant will support a 6-month trial involving 20 participants, advancing their efforts to develop effective ALS treatments.
- Tiziana Life Sciences invited to apply for a prestigious ALS Association grant, validating their scientific innovation.
- Prior positive results in non-active secondary progressive multiple sclerosis trials support the potential of intranasal foralumab.
- Increased patient enrollment in Expanded Access Program approved by FDA.
- The grant could fund a 6-month trial with 20 ALS patients, focusing on advanced imaging and clinical outcome assessments.
- Successful grant application could attract follow-on funding, de-risking further drug development.
- The grant application is not yet approved, posing uncertainty about the trial's funding.
- Current trials and Expanded Access Program results may not directly translate to ALS, representing a risk.
- Potential delays and challenges in trial execution could affect timelines and investor confidence.
- Dependency on external funding sources like grants adds financial vulnerability.
NEW YORK, June 04, 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 it has been honored with an invitation to apply for a prestigious grant from the ALS Association head by 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. The grant is offered as part of the Hoffman ALS Clinical Trial Awards Program, which is specifically designated to support a groundbreaking clinical trial.
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).
The Hoffman ALS Clinical Trial Awards Program 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.
Dr. Berry commented, “Tiziana’s study goal is to give people living with amyotrophic lateral sclerosis (ALS) the opportunity to participate in a 6-month, dose-titration trial of intranasal foralumab.” Dr. Babu expanded, “This study is aimed at advancing novel treatment approaches for ALS by evaluating its effect using cutting-edge image biomarkers like positron emission tomography (PET) and key clinical outcome assessments.”
ALS, also known as Lou Gehrig's disease, affects nerve cells in the brain and spinal cord, progressively weakening muscles. It is classified as an Orphan Disease due to its sporadic nature and lack of clear risk factors. With limited treatment options available, Tiziana Life Sciences is committed to developing novel therapies that address the underlying causes of ALS.
“The invitation to submit a letter of intent and apply for this grant with Drs. Berry and Babu underscores the recognition of Tiziana Life Sciences' dedication to scientific innovation and commitment to improving patient outcomes. If successful, the grant will support a clinical trial involving 20 patients, focusing on the evaluation of intranasal foralumab, a promising therapeutic candidate developed by the company,” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, expressing his gratitude for the opportunity, "We are deeply honored to be invited by the ALS Association to apply for this grant, which represents a significant milestone in our ongoing efforts to develop an effective treatment for ALS. This funding would allow us to advance our clinical program and accelerate the development of our potential therapy that could make a meaningful difference in the lives of ALS patients."
Tiziana Life Sciences remains committed to advancing research and development efforts aimed at addressing the unmet needs of patients suffering from ALS and other debilitating diseases. The company looks forward to the possibility of collaborating with the ALS Association to bring new hope to individuals affected by this devastating condition.
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 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.
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
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
Investors:
Irina Koffler
LifeSci Advisors, LLC
646.970.4681
ikoffler@lifesciadvisors.com
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120
FAQ
What is Tiziana Life Sciences' lead development candidate?
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What is the goal of the proposed clinical trial for intranasal foralumab?
What prior results support the potential of intranasal foralumab?
How many patients will participate in the proposed ALS clinical trial?
