Tiziana Life Sciences plc - Interim Results for the Six Months Ended 30 June 2021
24 Setembro 2021 - 1:51PM
London, 24 September 2021 – Tiziana Life Sciences plc (“Tiziana”,
LSE: TILS, NASDAQ: TLSA), a biotechnology company a biotechnology
company focused on innovative therapeutics for oncology,
inflammation, and infectious diseases today announces its interim
results for the six months ended 30 June 2021.
Highlights during the period:
CLINICAL PROGRAMMES
ForalumabTZLS-401
- Announced an update on further
analysis of lymphocyte subsets from blood samples from a Phase 1
study with nasally administered Foralumab in healthy volunteers.
Results exhibiting statistically significant immunomodulatory
effects on CD8 cytotoxic T-lymphocytes and other inflammatory
biomarkers were observed. Systemic levels of Foralumab were below
the lower quantitation limit of 8 ng/mL suggesting that nasally
administered Foralumab appears to exert its effects via nasal
epithelium utilizing local and lymphatic immune systems directly.
These data support other clinical and pre-clinical studies showing
that this route of administration is capable of inducing
site-targeted immunomodulation and anti-inflammatory effects.
Furthermore these pharmacodynamic data point to a clinical dose
range that Tiziana intends to test in further clinical development
among MS patients.
-
Announced positive data from the exploratory clinical study in
Brazil investigating nasally administered Foralumab, its
proprietary anti-CD3 human monoclonal antibody, either alone or in
combination with orally administered dexamethasone ("Dexa") in
COVID-19 patients. The clinical study was completed in
collaboration with scientific teams at the Harvard Medical
School (Boston, USA), and INTRIALS, a full-service Latin
American CRO based in São Paulo, Brazil. The objectives of the
trial were to assess safety of the treatment and to evaluate if
progression of the diseases is delayed with nasally administered
100mcg/day Foralumab (50mcg/nostril). This study enrolled 39
patients randomized in three cohorts: cohort 1, control with no
treatment (n=16); cohort 2; nasally administered Foralumab plus 3
days of priming with orally administered 6 mg Dexamethasone (n=11)
and cohort 3; nasally administered Foralumab (n=12). The Foralumab
treatment regimen was once a day dosing for 10 consecutive days
There were no significant differences between cohort 2 and 3. All
treatments were well-tolerated. There were no grade 3 or 4 severe
adverse events ("SAEs") in any of the cohorts. The CT scans of the
lungs showed the improvement was approximately double that shown in
patients treated with Foralumab as compared to those in the control
group. The results of the study were published in the peer-reviewed
journal, Frontiers in Immunology entitled "Nasal
Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces
Lung Inflammation and Blood Inflammatory Biomarkers in Mild to
Moderate COVID-19 Patients: A Pilot Study” in August 2021.
-
Signed an agreement with FHI CRO to conduct a follow-up, “proof of
concept” Phase 2 study in hospitalized patients with severe
COVID-19 and lung inflammation that is planned to begin in Q4 2021.
Foralumab will be delivered intranasally using a metered dose
delivery device.
-
Announced that the first patient with secondary progressive
multiple sclerosis (SPMS) was dosed with nasally administered
Foralumab at the Brigham and Women's
Hospital (BWH), Harvard Medical School, Boston,
MA. Nasal Foralumab 50 mcg (25 mcg/nostril) was administered
in 3-week cycles, with 3 times/week dosing for the first 2 weeks
followed by 1 week of rest period. This first-ever clinical study
in SPMS patients, under an Individual Patient Expanded Access IND,
will continue for six months to evaluate routine safety,
tolerability, and neurological behaviors. The study will also
examine microglial activation, by positron emission tomography
(PET), immunological and neurodegenerative markers to assess
clinical responses following the treatment regimen.
Anti IL-6R mAbTZLS-501, formerly NI-1201
- Working with
Sciarra Laboratories to evaluate two hand-held nebulizer devices
for use in the study and characterizing physical/performance
characteristics. Once a device has been selected, a few candidate
formulations of anti-IL6R mAb, from formulation development studies
at STC Biologics, will be manufactured at small scale and evaluated
using the devices.
-
Engaged ITR Laboratories in Canada to complete inhalation safety
toxicology studies in Cynomolgous monkeys using the purified,
characterized anti-IL6R mAb test item. Results from the study will
be used to establish dosing for a Phase 1 study in healthy
volunteers. Additional parenteral administration safety toxicology
studies are in progress at ITR Laboratories to support clinical
studies for treatment of autoimmune and inflammatory diseases.
Milciclib TZLS-201
- Announced that it had executed an
agreement with Takanawa Japan K.K, Pharma Team, (Takanawa) for a
strategic business development plan to Identify a clinical partner
in Japan and other Asian countries for further clinical
development of Milciclib for treatment in advanced hepatocellular
carcinoma (HCC) patients. HCC is the most common type of liver
cancer and affects approximately 200,000 people per year.
Intellectual Property
- As of September 2021, the Company
has a total of 306 granted patents, 281 foreign and 25 US
patents.
New appointments
- Appointed Dr. Neil Graham MBBS, MD, MPH as Chief Medical
Officer, Dr. Thomas Adams Ph.D. as Head of Drug Development and an
executive director and Dr. Kevin Schutz, PharmD, as Vice-President
of Regulatory Affairs.
Highlights post period end:
- On September 2, 2021, Tiziana and
Precision Biosciences announced an exclusive license agreement to
explore Tiziana’s foralumab as an agent to induce tolerance of
allogeneic CAR T cells to potentially improve the clinical outcome
of CAR T cell therapy. Precision’s approach to manufacturing
produces CAR T cells that are virtually CD3-negative. Foralumab
will be used as a lymphodepletion or tolerizing agent, either alone
or in combination with other co-stimulatory molecules, to improve
the long-term survival of CAR T cells in cancer treatment.
- Tiziana has formally commenced its
strategic plan to change its corporate structure by establishing
Tiziana Life Sciences Ltd, a Bermuda-incorporated company, as the
ultimate parent company of the of the Tiziana Group. The
reorganisation will be achieved by a scheme of arrangement under
Part 26 of the Companies Act 2006.
FINANCIAL
- For the six months to 30 June 2020 the consolidated Group made
a loss of £12.59m (six months to 30 June 2020: £3.9m).
- The Group ended the period with £38.6m cash as at 30 June 2021
(31 December 2020: £48.2m).
- Research and development (R&D)
expenses increased to £12.6m compared to £3.9m in the first half of
2020. The increase is primarily expenses related to the advancement
of our proprietary programs, TZLS-401 and TZLS-501.
- The Company cancelled the admission
of its Ordinary Shares to trading on AIM and admitted its shares to
trading on the main market for listed securities (of London Stock
Exchange plc in January 2021.
The Company continues to carefully manage its
working capital position and continues the process, as referred to
below, to evaluate opportunities to raise further funds through the
issue of additional equity capital.
To view the complete Interim Accounts click
here: https://ir.tizianalifesciences.com/financial-information/interim-reports
Contacts:
Tiziana Life Sciences plcGabriele Cerrone,
Chairman and founder |
+44 (0)20 7495 2379 |
About Tiziana Life Sciences
Tiziana Life Sciences plc is a dual listed
(NASDAQ:TLSA, UK LSE: TILS) biotechnology company that focuses on
the discovery and development of novel molecules to treat human
diseases in oncology, inflammation and infectious diseases. In
addition to Milciclib, the Company will be shortly initiating Phase
2 studies with orally administered Foralumab for Crohn's Disease
and nasally administered Foralumab for progressive multiple
sclerosis. Foralumab is the only fully human anti-CD3 monoclonal
antibody ("mAb") in clinical development in the world. This Phase 2
compound has potential application in a wide range of autoimmune
and inflammatory diseases, such as Crohn's Disease, multiple
sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease
("IBD"), psoriasis and rheumatoid arthritis, where modulation of a
T-cell response is desirable. The Company is accelerating
development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully
human monoclonal antibody for treatment of IL6-induced
inflammation, especially for treatment of COVID-19 patients.
Tiziana Life Sciences (NASDAQ:TLSA)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Tiziana Life Sciences (NASDAQ:TLSA)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024