TIDMTILS
RNS Number : 3714M
Tiziana Life Sciences PLC
28 July 2017
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Publication of Research Article on Foralumab, a Fully Human
Anti-CD3 Antibody Being Developed as an Oral Therapy for NASH and
Autoimmune Diseases
-- Foralumab (NI-0401) is a unique oral therapy that stimulates
the gut immune system and provides an anti-inflammatory therapeutic
effect in autoimmune diseases without immune suppression
-- Positive therapeutic effects of foralumab were consistently
demonstrated in pre-clinical studies conducted by Prof. Kevan
Herold (Yale University) and Prof. Howard Weiner (Harvard
University)
-- Oral efficacy in humanized mouse models with foralumab is a
major milestone and a potential breakthrough for treatment of NASH
and autoimmune diseases
London, July 28, 2017 - Tiziana Life Sciences plc (AIM: TILS,
the "Company"), the clinical stage biotechnology company developing
targeted drugs for cancer and autoimmune diseases, announces
publication of a research article in a prestigious journal,
Clinical Immunology, entitled: "Oral treatment with foralumab, a
fully human anti-CD3 monoclonal antibody, prevents skin xenograft
rejection in humanized mice"(1) . This is the first-ever published
report demonstrating the potential of oral therapy with foralumab
(NI-0401) for inflammatory diseases such as Non-alcoholic
steatohepatitis (NASH). Tiziana's foralumab is the only fully human
engineered anti-CD3 monoclonal antibody (mAb) in clinical
development to date.
"Until recently it has been generally accepted that despite the
convenience and appeal of oral therapies, immunotherapies could not
be administered orally because they would be degraded and
inactivated by the harsh conditions in the gastrointestinal tract,"
commented Gabriele Cerrone, Chairman of Tiziana Life Sciences. "New
data demonstrating oral efficacy in animals with foralumab is a
major milestone and opens a novel avenue for the treatment of NASH
and autoimmune diseases with fully human mAbs."
"Oral administration with biologics such as mAbs is a potential
game changer for immunotherapies enhancing drug safety while
potentiating immunomodulation to provide clinical responses," said
Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences. "Data
reported in this study demonstrate that our proprietary approach of
oral immunotherapy may have potential to be translated in human
clinical studies as well. "
Foralumab, a long half-life therapeutic mAb candidate, with high
affinity and potency for CD3 epsilon, has shown consistent efficacy
via oral administration in pre-clinical studies conducted by Prof.
Kevan Herold, a member of Tiziana's Scientific Advisory Board, at
Yale University. "This study demonstrates that oral administration
works consistently in our pre-clinical models with human immune
cells. This suggests that oral CD3-specific mAb has the potential
for treating NASH, diabetes, and other immune-mediated diseases in
humans - an entirely novel approach for the treatment of currently
unmet needs," commented Prof. Kevan Herold.
Further animal studies conducted by a member of Tiziana's
Scientific Advisory Board, Prof. Howard Weiner, in his laboratory
at the Harvard University further supports the potential of oral
treatment with foralumab for the treatment of autoimmune and
inflammatory diseases in humans. "Our data suggest that oral
treatment with anti-CD3 mAb induces an anti-inflammatory response
through induction of regulatory T cells (Tregs)," noted Prof.
Weiner, "This proof of concept of foralumab in humanized mice
demonstrates that this approach could be used successfully in
humans as well."
Dr. Ilan Yaron, Director of the Department of Medicine at Hebrew
University Hadassah Medical Center, Israel and Chief Medical
Officer of Tiziana Life Sciences, added: "Oral immunotherapy using
foralumab opens a whole new era in the treatment of immune-mediated
disorders. This drug has a potential for immune modulation without
generalized immune suppression, making it a novel therapeutic
approach for various indications. Tiziana is currently preparing
clinical trials to show the efficacy of foralumab in patients, and
our first study will determine the safety and efficacy of foralumab
in patients with NASH and type 2 diabetes. Foralumab could
potentially be an ideal option for patients with NASH in all stages
of disease progression, as it targets a pathogenic mechanism which
is common to all disease stages."
References
1: Oral treatment with foralumab, a fully human anti-CD3
monoclonal antibody, prevents skin xenograft rejection in humanized
mice. Ogura M(1) , Deng S(1) , Preston-Hurlburt P(1) , Ogura H(1) ,
Shailubhai K(2) , Kuhn C(3) , Weiner HL(3) , Herold KC(4) . Clin
Immunol. 2017 Jul 21. pii: S1521-6616(17)30342-X. doi:
10.1016/j.clim.2017.07.005. [Epub ahead of print]
About NASH
Non-alcoholic fatty liver disease (NAFLD) is one of the causes
of fatty liver, which occurs when fat is deposited (steatosis) in
the liver due not related to alcohol use. It affects 30% of the
western world population. Non-alcoholic steatohepatitis (NASH) is a
severe type of NAFLD. NASH occurs when the accumulation of liver
fat is accompanied by inflammation and cellular damage. The
inflammation can lead to fibrosis (scarring) of the liver and
eventually progress to cirrhosis, portal hypertension, liver cancer
and liver failure. According to a market research report
Nonalcoholic Steatohepatitis Treatment Market 2015-2025 published
by iHealthcareAnalyst, Inc., the global non-alcoholic
steatohepatitis treatment market is estimated to reach USD 19.5
Billion in 2025, expanding at a current annual growth rate of 10.0%
from 2016 to 2025. Currently there is no approved therapy for
NASH.
About Kevan Herold, MD
Dr. Kevan Herold is Professor of Immunobiology and of Medicine
(Endocrinology) as well as Deputy Director, Yale Center for
Clinical Investigation, Director of the Yale Diabetes Center and
the TrialNet Center at Yale. His investigative work has focused on
developing new ways to prevent and treat autoimmune diseases, using
novel translational immunologic strategies. He is a leader
particularly in the field of type 1 diabetes and had led several
investigative trials for prevention and treatment. He is involved
with national and international consortia that are developing new
treatments for diabetes and other immune system disorders. His
laboratory studies focus on understandings the mechanisms of
autoimmune disease and the treatments that are being developed. His
clinical interests are as an endocrinologist who specialises in
management and treatment of diabetes.
About Howard L. Weiner, MD
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 Ilan Yaron, MD
Prof. Ilan Yaron is the Director of the Department of Medicine
at the Hadassah-Hebrew University Medical Center in Jerusalem
Israel and served as the Vice Dean of the Hebrew
University-Hadassah Medical School. He has pioneered the
development of oral immunotherapy for NASH, diabetes, and
inflammatory bowel diseases. He developed several products which
target the immune system of the gastrointestinal tract as a mean
for alleviating immune-mediated disorders without the need for
immunosuppression. He holds over 50 patents for discoveries based
on his research mainly in oral immunotherapy and mucosal
immunology. His clinical interests are in the management of NASH
and diabetes by targeting the inflammation-associated with these
diseases by using products with high safety profile enabling their
chronic use. He is involved in multiple clinical trials using oral
immunotherapy-based compounds.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that
focuses on the discovery and development of novel molecules that
treat human disease in oncology and immunology.
The Company is focused on its lead compound, milciclib, a
molecule which blocks the action of specific enzymes called
cyclin-dependent kinases (CDK) involved in cell division as well as
a number of other protein kinases. Milciclib is currently
completing phase II clinical trials for epithelial thymic carcinoma
and/or thymoma in patients previously treated with chemotherapy and
has filed an IND to enroll patients in an exploratory trial in
Hepatic Cellular Carcinoma (HCC).
The Company is also in clinical development of foralumab.
Foralumab is the only fully human engineered anti-human CD3
antibody in clinical development. This phase II compound has
potential application in a wide range of autoimmune and
inflammatory diseases, such as 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.
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.
Contacts
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder +44 (0)20 7493 2853
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray +44 (0)20 7213 0883
Beaufort Securities Limited (Broker)
Saif Janjua +44 (0)20 7382 8300
FTI Consulting
Simon Conway / Natalie Garland-Collins +44 (0)20 3727 1000
The company news service from the London Stock Exchange
END
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