Tiziana Life Sciences Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy...
16 September 2019 - 9:44PM
Business Wire
A breakthrough approach for treatment of
autoimmune and inflammatory diseases
THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE
COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU
MARKET ABUSE REGULATION (596/2014). UPON PUBLICATION OF THE
ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION
IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.
Tiziana Life Sciences plc (NASDAQ:TLSA and AIM: TILS), a
clinical stage biotechnology company focused on developing targeted
drugs for cancer and inflammatory diseases, is pleased to announce
(further to the announcement made on 1 May 2019) that the U.S. Food
and Drug Administration (FDA) has allowed the initiation of a Phase
I clinical trial in healthy volunteers using a novel oral
enteric-coated capsule formulation of Foralumab, a fully human
monoclonal antibody (mAb), in collaboration with the Brigham and
Women’s Hospital (BWH), Harvard Medical School, Boston, MA. This is
the first clinical trial in which Foralumab will be administered
orally to healthy subjects. Our objective is to develop orally
administered Foralumab for treatment of autoimmune and inflammatory
diseases.
The scientific rationale for this approach was originally
discovered by Dr. Howard Weiner, professor at the Brigham and
Women’s Hospital, Harvard Medical School. Dr. Weiner discovered
that oral or nasal administration of anti-CD3 mAb induces mucosal
tolerance to upregulate T regulatory cells (Tregs) capable of
providing site-targeted immunomodulation to suppress inflammation.
Therefore, this scientific concept could be effective for the
treatment of a variety of autoimmune and inflammatory
diseases1-5.
“The therapeutic approach of oral administration with Foralumab
should greatly enhance our ability to treat neurodegenerative and
inflammatory diseases. We have also explored the nasal
administration of Foralumab for the treatment of progressive MS. We
believe nasal and oral administration with Foralumab opens
innovative avenues to treat inflammatory and autoimmune diseases by
inducing different classes of Tregs. Thus, mucosal activation
stimulating Tregs is a physiological mechanism which we think might
be safer than other treatment approaches,” commented Dr.
Weiner.
Cited References
- Wu HY, Maron R, Tukpah AM, Weiner HL. Mucosal anti-CD3
monoclonal antibody attenuates collagen-induced arthritis that is
associated with induction of LAP+ regulatory T cells and is
enhanced by administration of an emulsome-based Th2-skewing
adjuvant. J Immunol. 2010; 185(6):3401-3407.
- Ochi, H.,et al., Oral CD3-specific antibody suppresses
autoimmune encephalomyelitis by inducing CD4+CD25-LAP+ T cells.
Nature Medicine 2006: 12: (6); 627-635
- Lior Mayo, Andre Pires Da Cunha, Asaf Madi, Vanessa Beynon,
Zhiping Yang,Jorge I. Alvarez, Alexandre Prat, Raymond A. Sobel,
Lester Kobzik, Hans Lassmann, Francisco J. Quintana and Howard L.
Weiner. IL-10-dependent Tr1 cells attenuate astrocyte activation
and ameliorate chronic central nervous system inflammation. Brain
2016: 139; 1939–1957
- Chantal Kuhn, Rafael M. Rezende, Andre Pires da Cunha, Fabrice
Valette, Francisco J. Quintana, Lucienne Chatenoud, Howard L.
Weiner. Mucosal administration of CD3-specific monoclonal antibody
inhibits diabetes in NOD mice and in a preclinical mouse transgenic
for the CD3 epsilon chain. Journal of Autoimmunity (2016) 76:
1-8
- Ogura M, et al., Prevention of human xenograft rejection with
oral anti-CD3 mAb. Clinical Immunology 183: 2017; 240-246
About Howard Weiner
Howard L. Weiner is the Robert L. Kroc Professor of Neurology at
the Harvard Medical School, Director and Founder of the Partners
Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney
Center for Neurologic Diseases at Brigham & Women's Hospital in
Boston. He has pioneered immunotherapy in MS and has investigated
immune mechanisms in nervous system diseases including MS,
Alzheimer's disease, amyotrophic lateral sclerosis, stroke and
brain tumours. He has also pioneered the investigation of the
mucosal immune system for the treatment of autoimmune and other
diseases and the use of anti-CD3 to induce regulatory T cells for
the treatment of these diseases.
About Harvard Medical Centre
Brigham and Women's Hospital (BWH, "The Brigham") is located
adjacent to Harvard Medical School, of which it is the second
largest teaching affiliate. It is the largest hospital of the
Longwood Medical and Academic Area in Boston, Massachusetts, USA.
With Massachusetts General Hospital, it is one of the two founding
members of Partners HealthCare, the largest healthcare provider in
Massachusetts. Brigham and Women's Hospital conducts the second
largest hospital-based research program in the world, with an
annual research budget of more than $630 million. Pioneering
milestones include the world's first successful heart valve
operation and the world's first solid organ transplant.
About Autoimmune Diseases and Foralumab
Autoimmune diseases constitute a major medical problem and
include diseases such as multiple sclerosis, type 1 diabetes,
rheumatoid arthritis and inflammatory bowel disease. Other
diseases, that have inflammatory components include diseases such
as NASH, atherosclerosis and stroke. The induction of regulatory
cells at mucosal surfaces by the oral or nasal administration of
antigens has been shown to treat a large variety of autoimmune and
inflammatory diseases in animal models with minimal toxicity.
Foralumab was developed by Novimmune and has been acquired by
Tiziana Life Sciences PLC. Foralumab (formerly NI-0401) is thus far
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 IL2γc-/-) developed in Dr
Kevan Herold’s laboratory, it was show that while targeting the T
cell receptor, orally administered foralumab modulates immune
responses of the T cells, enhances regulatory T cells 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 regulatory T cells.
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 known to the company in clinical development in the world.
This compound has potential application in a wide range of
autoimmune and inflammatory diseases, such as non-alcoholic
steatohepatitis (NASH), primary biliary cholangitis (PBS),
ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D),
inflammatory bowel disease (IBD), psoriasis and rheumatoid
arthritis, where modulation of a T-cell response is desirable.
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 more information go to http://www.tizianalifesciences.com
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
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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 0883
Shore Capital (Nominated brokers) Antonio Bossi / Andy
Crossley +44 (0)20 7408 4050
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