TIDMTILS
RNS Number : 9068E
Tiziana Life Sciences PLC
11 November 2020
Tiziana Life Sciences PLC
("Tiziana" or "the Company")
Phase 1b/2 Clinical Trial - Crohn's Disease
Tiziana Life Sciences announces collaboration with Parexel
Biotech to conduct phase 1b/2 clinical trial in patients with
Crohn's Disease
First Ever Study with take-home capsules of Foralumab, a Fully
Human Anti-CD3 Monoclonal Antibody
- Potential to be a safer and effective alternative to the
intravenous immunotherapies currently used for Crohn's Disease
-Crohn's Disease Therapeutics Market Size $4.7 Billion by
2025
Phase1b/2 clinical study to be conducted in the United States
and several European countries
NEW YORK and LONDON, 11 November 2020 - Tiziana Life Sciences
plc (Nasdaq: TLSA; AIM: TILS) ("Tiziana" or the "Company"), a
biotechnology company focused on innovative therapeutics for
oncology, inflammation and infectious diseases, today announced it
is collaborating with Parexel Biotech ("Parexel"), a division of a
leading global clinical research organization ("CRO"), Parexel
International (IRL) Limited, to conduct a global Phase 1b/2 trial
with enteric-coated capsules of formulated Foralumab, the only
fully human anti-CD3 monoclonal antibody ("mAb") - as a therapy for
patients with moderate to severe Crohn's Disease ("CD"). This
clinical study will evaluate the safety, tolerability, and clinical
activity of escalating doses of orally administered capsules of
Foralumab. The trial is a dose-ranging, open-label study that will
enroll 60 patients in the U.S. and Europe.
Dr. Howard L. Weiner, chairman of the scientific advisory board
of Tiziana Life Sciences, commented:
"We understand that this will be the first-ever study with
'take-home' capsules of any mAb for immunotherapies for human
diseases. We believe the scientific rationale for oral treatment
with Foralumab is logical to facilitate topical action at the
inflamed sites in the gastrointestinal tract. This potentially
ground-breaking approach for immunotherapies originated in my
laboratory and was subsequently reported by other researchers in
the field"
"Recently, we also successfully demonstrated that nasally
administered Foralumab is not only well-tolerated, but also
produced desirable immunological responses. Oral and nasal
administration routes are both physiologic approaches to stimulate
the mucosal immune system to induce disease modifying
benefits."
The CD therapeutic market size will be worth $4.7 Billion by
2025, according to Grand View Research (1) . CD is a chronic
disorder of the immune system that causes inflammation throughout
the digestive tract. Although the specific causes of CD are still
not clearly understood, severe gut inflammation caused by an
overactive immune system attacking the intestines, colon and other
organs appears to contribute to disease pathology. Thus,
immunosuppressive agents and anti-TNF (Tumour Necrosis Factor)
immunotherapies represent the main therapeutic options to maintain
remission in CD. However, severe toxicities and poor patient
compliance limit the long-term use for intravenous immunotherapies.
Oral administration with take-home capsules of Foralumab is a very
attractive approach as it may provide local action to treat gut
inflammation in patient with CD. Additionally, oral capsules
provide the convenience of home use, and increase patient
compliance by eliminating the need for infusions in a clinic or
hospital setting.
"The prevalence of inflammatory bowel disease is rising
globally, imposing a significant burden both on patients as well as
healthcare systems worldwide," said Sy Pretorius, MD, Parexel
Executive Vice President and Chief Medical & Scientific
Officer. "We're excited to be collaborating with Tiziana to support
the development of a novel, oral therapy that could provide Crohn's
patients with another option in their repertoire of treatments to
combat this devastating disease."
Recently, Tiziana announced positive results from its Phase 1
study showing that oral treatment with Foralumab was well-tolerated
in healthy volunteers, with no drug-related safety issues even at
the highest dose of 5 mg(2) . Oral administration of anti-CD3
monoclonal antibody is a novel approach to induce an
anti-inflammatory immune response to suppress inflammation by
inducing T regulatory (Tregs) cells in animal studies(3,4) .
Importantly, oral treatment with OKT3, a mouse anti-CD3 mAb, showed
clinical responses which were reversed following discontinuation of
treatment, suggesting oral treatment with OKT3 may have potential
for treatment of moderate to severe ulcerative colitis(5) .
Dr. Shailubhai, CEO & CSO of Tiziana Life Sciences,
commented:
"Previously, we reported that oral administration of Foralumab
was well-tolerated and that the treatment did not result in severe
toxicities that are so commonly observed with intravenous (IV)
administration of anti-CD3 mAbs, suggesting that oral
administration may be able to minimize toxicities and thereby
improve clinical outcome. Our patent on the core formulation
technologies covering alternative routes of administration for
immunotherapies has been already granted in the USA and it is
pending in other countries world-wide. We believe switching to
oral, nasal and inhalational administration of mAbs from the
traditional intravenous administration could potentially be
transformational for the future development of
immunotherapies."
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014. The person who arranged for
the release of this announcement on behalf of the Company was Dr
Kunwar Shailubhai, Chief Executive Officer and Chief Scientific
Officer of the Company.
Cited References:
1. Grand View Research August 2018 (
https://www.grandviewresearch.com/press-release/global-crohns-disease-therapeutics-market
).
2. Tiziana Life Sciences January 9, 2020 Press Release (
https://ir.tizianalifesciences.com/news-releases/news-release-details/tiziana-life-sci-plc-further-re-foralumab-phase-1-trial
)
3. da Cunha, A. P., and Weiner, H. L. (2012) Induction of
immunological tolerance by oral anti-CD3. Clin Dev Immunol 2012,
425021
4. Ogura, M., Deng, S., Preston-Hurlburt, P., Ogura, H.,
Shailubhai, K., Kuhn, C., Weiner, H. L., and Herold, K. C. (2017)
Oral treatment with foralumab, a fully human anti-CD3 monoclonal
antibody, prevents skin xenograft rejection in humanized mice. Clin
Immunol 183, 240-246
5. Boden, E. K., Canavan, J. B., Moran, C. J., McCann, K., Dunn,
W. A., Farraye, F. A., Ananthakrishnan, A. N., Yajnik, V., Gandhi,
R., Nguyen, D. D., Bhan, A. K., Weiner, H. L., Korzenik, J. R., and
Snapper, S. B. (2019) Immunologic Alterations Associated With Oral
Delivery of Anti-CD3 (OKT3) Monoclonal Antibodies in Patients With
Moderate-to-Severe Ulcerative Colitis. Crohn's & Colitis 360,
Volume 1, Issue 2, July 2019, otz009
About Foralumab
Foralumab (formerly NI-0401), the only entirely human anti-CD3
mAb, shows reduced release of cytokines after IV administration in
patients with Crohn's disease with decreases in the classic side
effects of cytokine release syndrome (CRS) and improves the overall
safety profile of Foralumab. In a humanized mouse model (NOD/SCID
IL2<GAMMA>c-/-), it was shown that while targeting the T cell
receptor, orally administered Foralumab modulates immune responses
of the T cells, enhances Tregs and thus provides therapeutic
benefit in treating inflammatory and autoimmune diseases without
the occurrence of potential adverse events usually associated with
parenteral mAb therapy (Ogura M. et al., 2017). Based on animal
studies, the nasal and oral administration of Foralumab offers the
potential for the immunotherapy of autoimmune and inflammatory
diseases in a safe manner by the induction of Tregs.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that
focuses on the discovery and development of novel molecules to
treat human disease in oncology and immunology. In addition to
Milciclib, the Company is also developing Foralumab for liver
diseases. Foralumab is the only fully human anti-CD3 monoclonal
antibody in clinical development in the world. This Phase 2
compound has potential application in a wide range of autoimmune
and inflammatory diseases, such as nonalcoholic steatohepatitis
(NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes
(T1D), Crohn's disease, 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.
About Parexel
Parexel Biotech is a division of leading global clinical
research organization (CRO), Parexel International (IRL) Limited,
and provides tailored solutions for biotech and medical device
companies to accelerate their development goals and help them
achieve faster market access.
Parexel is focused on supporting the development of innovative
therapies to improve patient health. During the COVID-19 crisis, we
continue to be committed to our customers' business while putting
the safety of patients, client partners and our employees at the
heart of everything we do. To learn more about our efforts related
to COVID-19, as well as the experts, innovations and processes we
have in place to navigate the rapidly changing landscape, visit us
at website and follow us on LinkedIn , Twitter and Instagram .
Forward-Looking Statements
Certain statements made in this announcement are forward-looking
statements. These forward-looking statements are not historical
facts but rather are based on the Company's current expectations,
estimates, and projections about its industry; its beliefs; and
assumptions. Words such as 'anticipates,' 'expects,' 'intends,'
'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions
are intended to identify forward-looking statements. These
statements are not guarantees of future performance and are subject
to known and unknown risks, uncertainties, and other factors, some
of which are beyond the Company's control, are difficult to
predict, and could cause actual results to differ materially from
those expressed or forecasted in the forward-looking statements.
The Company cautions security holders and prospective security
holders not to place undue reliance on these forward-looking
statements, which reflect the view of the Company only as of the
date of this announcement. The forward-looking statements made in
this announcement relate only to events as of the date on which the
statements are made. The Company will not undertake any obligation
to release publicly any revisions or updates to these
forward-looking statements to reflect events, circumstances, or
unanticipated events occurring after the date of this announcement
except as required by law or by any appropriate regulatory
authority
For further enquiries:
United Kingdom Investors:
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated
Adviser)
Liam Murray / Jo Turner +44 (0)20 7213 0880
Optiva Securities Limited (Broker)
Robert Emmet + 44 (0)20 3981 4173
United States Investors:
Dave Gentry Office 1 800 RED CHIP (733
RedChip Companies Inc. 2447)
Cell 407-491-4498 (USA)
dave@redchip.com
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