Full Press Release Details
Tiziana Life Sciences Ltd
("Tiziana" or "the Company")
Update and Interim Results for the Six Months
October 18, 2024 - Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology
company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced interim financial results
for the six months ended June 30, 2024, and provided a corporate update on its lead programs in development.
Cerrone, Executive Chairman, and founder of Tiziana, commented, "The past six months have been defined by meaningful strides
in advancing our portfolio of innovative therapeutic candidates. In particular, we are encouraged by the progress in our lead programs
targeting neurodegenerative and autoimmune diseases. Our lead asset, foralumab, continues to show significant promise in our expanded
access program for multiple sclerosis (MS), which has reaffirmed our confidence in its potential to revolutionize treatments in this area.
We have also achieved a key milestone in our intranasal
formulation of foralumab, the start of our Phase 2 study for non-active (non-relapsing) Secondary Progressive Multiple Sclerosis. The
positive early-stage clinical data from our expanded access Multiple Sclerosis studies have been very encouraging, indicating the potential
of our novel approach to delivering therapies with increased efficacy and fewer side effects compared to traditional treatments. As we
continue to evaluate these outcomes, we are optimistic that this can offer patients a much-needed, more tolerable option for managing
We have been awarded Fast Track designation by
the FDA, which is a significant milestone, providing an expedited review process and increased interaction with the FDA. This designation
is intended to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical
Half 2024 Developments Related to Foralumab
announced the filing of a new patent application relating to composition and methods for combining GLP-1ra and foralumab, a fully human
anti-CD3 antibody, to achieve further reductions in systemic and vascular inflammation associated with Type 2 Diabetes (T2D) and also
in a separate population of patients with non T2D obesity.
announced that positive findings had been seen in a total of six out of eight Intermediate Size Patient Population Expanded Access (EA)
patients. These patients had shown improvements in fatigue scores measured by the Modified Fatigue Impact Scale (MFIS). PET scan findings
showing a reduction in microglial activation were also seen in the six patients with MFIS score improvement at the three-month evaluation
announced a platform presentation titled, "Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical
Progression in Non-Active Secondary Progressive MS" at the Annual Meeting of the American Academy of Neurology in Denver, Colorado.
The presentation included new, encouraging quantitative imaging data from foralumab's intermediate-size patient population Expanded
Access Program. In the presentation, foralumab, a fully human anti-CD3 monoclonal-antibody showed the attenuation of microglial activation
in patients with non-active secondary progressive multiple sclerosis (na-SPMS) based on positron emission tomography (PET) imaging and
disease stabilization in na-SPMS patients with disease progression independent of relapse (PIRA).
presentation, delivered by Tarun Singhal, M.B.B.S., M.D., Director of the PET Imaging Program in Neurologic Diseases at Brigham and Women's
Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School,
assessed the effect of intranasal foralumab on microglial activation in na-SPMS patients with PIRA as measured by positron emission tomography
(PET) imaging via [F-18]PBR06-PET, a novel, long-half-life ligand used in PET scanning. The study is designed to be open-label and part
of the Expanded-Access Program evaluating foralumab in na-SPMS patients that is currently underway.
six patients (83%, 95% confidence interval 44%-97%) showed a qualitative reduction on [F-18]PBR06-PET in multiple brain regions after
both 3 and 6 months of nasal foralumab treatment, which implies that there is in vivo evidence for reduced microglial
activation and neuroinflammation following treatment with nasal foralumab. White matter z-scores (a measure of abnormally increased neuroinflammation)
were reduced by 26-36% in the foralumab-treated group at 3 and 6 months, which was >4-5-times higher compared to 6% variability in
the test-retest group. Clinically, foralumab-treated patients demonstrated a stable EDSS and improvement in the Modified Fatigue Impact
Scale (MFIS). Reduction in fatigue as measured by the MFIS is clinically relevant to the lives of na-SPMS patients and will be a key monitoring
parameter moving forward.
foralumab attenuated microglial activation in na-SPMS patients with PIRA at 3 and 6 months, as evaluated by [F-18]PBR06-PET and was associated
with clinical symptom stability. Based on these positive results, a double-blind, placebo-controlled, dose-ranging study of nasal-foralumab
in na-SPMS with [F-18]PBR06-PET as a primary endpoint with measures of EDSS and MFIS is underway. This trial (NCT06292923) is important
because if the potential to slow disease progression is demonstrated this would align with early treatment intervention.
announced additional positive clinical results from its intermediate sized Expanded Access Program (EAP) for non-active secondary progressive
multiple sclerosis (na-SPMS) patients. The data demonstrated multiple improvements in foralumab-treated patients, with 70% showing an
improvement in fatigue after six months of follow-up. Fatigue is a debilitating symptom for many MS patients and is measured by the Modified
Fatigue Impact Scale (MFIS).
also announced that the U.S. Food and Drug Administration (FDA) had allowed its intranasal foralumab non-active Secondary Progressive
Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program to expand from 10 patients to a total of 30 patients.
April, of the 10 participating patients, two patients had been dosed for more than one year and eight additional patients had been dosed
for six months, all without serious side effects. All patients had either stabilized or improved on treatment with foralumab, and no patients
have declined in key clinical measures. Additionally, 70% of these patients had seen a measurable improvement in fatigue. These data were
the first to combine PET imaging with a novel ligand, immune-biomarkers, clinical measures and comprehensive safety data endpoints in
patients receiving long-term intranasal foralumab. Patients not eligible for the Phase 2a trial may now be considered for this expanded
also announced for the first time, quantitative data showing improvement in White Matter Z-scores measured from PET images taken at 3
months in nasal foralumab treated patients with non-active secondary progressive multiple sclerosis (na-SPMS). White Matter Z-scores are
a statistical measure used in neuroimaging studies to assess the integrity or abnormalities in structures of the brain.
announced it had submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary
progressive Multiple Sclerosis (na-SPMS). This request would make foralumab the first therapy for na-SPMS to receive Orphan Drug Designation.
Our request is supported by clinical and non-clinical evidence of foralumab's effectiveness in na-SPMS. The prevalence estimates,
in part, are supported from the Brigham & Women's Hospital, Boston, Massachusetts, longitudinal study, the CLIMB data of which
allowed the estimate of na-SPMS in the population. The FDA have requested further information from Tiziana with regards to this
announced the qualitative results for all 10 non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients enrolled in the intermediate-size
patient population Expanded Access (EA) Program receiving foralumab for at least six months. Qualitative improvements in PET imaging were
seen in 80% of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access patients receiving intranasal foralumab for
also announced that the U.S. Food and Drug Administration (FDA) had allowed intranasal foralumab to be used under an Expanded Access (EA)
IND in its first patient with moderate Alzheimer's disease. Expanded access IND's provide a pathway for patients to gain access
to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions
for which there are no comparable or satisfactory therapy options available outside of clinical trials.
Recent Clinical Program Updates
announced the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for its intranasal formulation of foralumab,
a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
Track designation is a significant milestone, providing an expedited review process and increased interaction with the FDA. This designation
is intended to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical
need. Only four Fast Track designations have been granted in 2024 by FDA's Center for Drug Evaluation and Research as of March
Recent Operational Updates
the Company announced the appointment of Ivor Elrifi as Chief Executive Officer (CEO), effective immediately. Ivor was formerly the global
head of the Patent Group at Cooley since 2014 and before that the global head of Patents at Mintz Levin from 1999 - 2014. He has
counseled companies in various key industries, including pharmaceutical, biotechnology, life sciences and medical device companies, research
institutions, universities, hospitals and governments throughout the world, particularly in the US and Europe. Ivor has guided clients
in developing and implementing intellectual property strategies and in the prosecution, licensing and enforcement of patents. He has extensive
experience in advising clients on strategic transactional work and regularly counsels clients with respect to investments, business development
and mergers and acquisitions, including acquisition transactions involving Novartis, Eli Lilly, Biogen and Astellas. He has received various
awards throughout his career, including being named an "LMG Life Sciences: Life Science Star," and ranked nationally in Chambers
USA since 2007. Ivor earned his B.S. and Ph.D. in Biology from Queen's University and his J.D. from Osgoode Hall Law School.
First Half Financial Results
six months ended June 30, 2024 Tiziana reported a total comprehensive loss of $4.7 million compared to $6.9 million for the same period
had $1.1 million in cash as of 30 June 2024 as compared to $1.2 million on 31 December 2023. Additionally, Tiziana had $6.6 million
of other receivables as of 30 June 2024 as compared to $6.1million on 31 December 2023. Post the period end, Tiziana received an
additional $3.3 million in non-dilutive funding.
Annual Report on Form 20-F can be accessed by visiting either the SEC's website at www.sec.gov or the Investors section of the Company's
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