Tiziana Life Sciences Announces Podium Presentation at AD/PD of Nasal Anti-CD3 in Alzheimer’s Disease
- Positive data presented at AD/PD conference on intranasal anti-CD3 monoclonal antibody for Alzheimer’s and Parkinson’s disease
- Reduction in microglia activation and improvement in behavior observed in rodent models
- Nasal anti-CD3 demonstrated reduction in hemorrhage and edema associated with ARIA
- Neuroinflammation modulation could synergize with existing FDA approved treatments for Alzheimer’s Disease
- None.
Insights
The recent findings from Tiziana Life Sciences regarding their intranasal anti-CD3 monoclonal antibody therapy for Alzheimer's and Parkinson's disease represent significant progress in the field of neuro-immunomodulation. The reduction of microglia activation observed in rodent models could indicate a promising pathway for addressing the neuroinflammation associated with these neurodegenerative diseases. Microglia are the primary immune cells in the brain and their overactivation is a hallmark of neuroinflammation, which is thought to contribute to the progression of diseases like Alzheimer's and Parkinson's.
In terms of therapeutic development, the potential synergistic effects with existing anti-amyloid treatments for Alzheimer's could enhance the overall efficacy of the disease management. The current anti-amyloid therapies aim to reduce the accumulation of beta-amyloid plaques, a characteristic of Alzheimer's; however, they do not directly address neuroinflammation. Combining these approaches could lead to more comprehensive treatment strategies. Furthermore, the ability of this therapy to reduce hemorrhage and edema associated with amyloid-related imaging abnormalities (ARIA) is noteworthy, as ARIA is a significant side effect of some anti-amyloid therapies.
For stakeholders, particularly investors in biotechnology, these findings could signal a potential for new therapeutic avenues and partnerships, especially if the therapy proves to be effective in human trials. However, it is important to note that these results are preliminary and based on animal models and the efficacy and safety in humans are yet to be established.
The announcement by Tiziana Life Sciences could have positive implications for the company's stock valuation, as breakthroughs in treatment for diseases like Alzheimer's and Parkinson's often lead to increased investor interest. The development of a novel, first-in-class neuroinflammatory modulator that is potentially synergistic with approved treatments could position Tiziana as a leader in a niche market. The market for Alzheimer's and Parkinson's treatments is substantial, given the prevalence of these conditions and the lack of curative therapies.
However, investors should consider the typical volatility associated with biotech stocks, especially those reliant on the success of clinical trials. The transition from positive animal model results to successful human clinical trials is fraught with risk and many compounds fail to make this leap. Long-term investment in such companies should be weighed against the potential for significant delays or failures in the drug development process.
The approach taken by Tiziana Life Sciences to target the Monocyte-Microglial axis represents a novel strategy in the treatment of neurodegenerative diseases. The modulation of innate immunity through intranasal delivery is particularly intriguing because it suggests a method of bypassing the blood-brain barrier, which is a significant obstacle in the development of central nervous system therapies. The reduction of microglia activation could potentially slow the progression of Alzheimer's and Parkinson's by mitigating the damaging inflammatory response.
While these findings are promising, the medical community will be keenly interested in the translation of these results to human subjects. The true test of this therapy's potential will be in its safety profile and effectiveness in human clinical trials. If successful, this therapy could become an integral component of multimodal treatment regimens for these neurodegenerative diseases.
- Data shows reduction of microglia activation and improvement in behavior in rodent models of Alzheimer’s disease (AD) and Parkinson’s disease (PD)
- Nasal anti-CD3 reduced hemorrhage and edema that occurs with ARIA based on animal studies
- Neuroinflammation modulation may be synergistic to approved treatments in Alzheimer’s Disease
NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced that Dr. Howard Weiner will present positive data of intranasal anti-CD3 monoclonal antibody in models of Alzheimer’s and Parkinson’s disease at AD/PD, March 5-9, 2024. AD/PD is the annual International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Lisbon, Portugal.
Presentation Information
Presenter: Howard L Weiner, M.D.
Title: Nasal immunotherapy of the Monocyte-Microglial axis to treat Alzheimer’s Disease
Day: Friday, March 8th
Time: 15:05 UTC
Location: Auditorium V
Howard L. Weiner, M.D., Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham, and Chairman of Tiziana's Scientific Advisory Board, stated, “I believe that the modulation of innate immunity via targeting microglia will play a synergistic role with the currently approved anti-amyloid Alzheimer’s treatments. Our research has demonstrated that intranasal rodent anti-CD3 mAb and intranasal fully human anti-CD3 mAb (foralumab) will decrease microglia activation in rodents and humans, respectively. Nasal anti-CD3 has also shown to reduce hemorrhage and edema that occurs with ARIA.”
“With the focus on effective Alzheimer’s disease treatments and we have the potential to be a novel, first in class neuroinflammatory modulator,” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences. “Our intranasal approach has large potential as it does not target beta-amyloid or other proteins, but focuses on the neuroinflammatory process itself, which may be complementary or synergistic with existing FDA approved treatments. The data also excitingly shows a reduction of hemorrhage and edema that occurs with ARIA.”
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 dosed its first patient in December 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 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
+1 646 970 4681
ikoffler@lifesciadvisors.com
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1 https://www.pnas.org/doi/10.1073/pnas.2220272120
2 https://www.pnas.org/doi/10.1073/pnas.2309221120
FAQ
What data did Tiziana Life Sciences present at the AD/PD conference?
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