Tiziana Life Sciences plc ("Tiziana" or the "Company") Tiziana Reports Phase 1 Clinical Data Demonstrating Oral Treatment with Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, is Well-tolerated in Healthy Volunteer

Reports Phase 1 Clinical Data Demonstrating Oral Treatment with Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, is Well-tolerated

in Healthy Volunteers

announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

York/London, 9 January 2020 - Tiziana Life Sciences plc (Nasdaq: TLSA) ("Tiziana" or the "Company"),

a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, is pleased to report completion

of a Phase 1 clinical study of Foralumab, a fully human anti-CD3 monoclonal antibody ("mAb"), in healthy subjects.

The proprietary oral formulation, comprising the lyophilized and stabilized free-flowing powder of formulated Foralumab encapsulated

in an enteric-coated capsule, was well-tolerated at all doses tested and there were no drug-related safety issues even at the

highest dose of 5 mg in this trial.

Phase 1 trial, conducted at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA, was a single-site,

double-blind, placebo-controlled, single ascending dose ("SAD") study in healthy subjects in which Foralumab was orally

administered at 1.25, 2.5 and 5.0 mg per dose as enteric-coated capsules. Each cohort comprised of 4 subjects, of whom 3 received

Foralumab treatment and 1 received a placebo capsule. All subjects completed the trial without any safety concerns at any of the

has previously been shown that orally administered Foralumab to NOD/SCID IL2 c-/- mice (which have human immune systems)

with skin xenografts was well-tolerated up to 15 g/day (n=20; human equivalent dose of 3.66 mg/dose in a 60 kg human) for

5 days then weekly, prevented skin xenograft rejection indefinitely. Clinical studies conducted by other researchers have also

shown that oral administration of OKT3, a murine anti-CD3 mAb, was well-tolerated up to 5 mg/day for 5 days to healthy subjects,

to patients with nonalcoholic steatohepatitis ("NASH") for 30 days and to hepatitis C virus (HCV) non-responders for

30 days. Data from a recently completed clinical study indicated that oral administration of OKT3 was well tolerated at 1 mg/day

for 30 consecutive doses in patients with moderate-to-severe ulcerative colitis. Importantly, the treatment resulted in clinical

responses in 3 out of 6 patients, including one patient with a complete clinical response.

is the first -ever study demonstrating that orally administered Foralumab is well-tolerated at all doses up to 5.0 mg/dose. This

ground breaking study opens a novel avenue for future development of oral mAb therapeutics " commented Dr. Howard L. Weiner,

a member of the scientific advisory board of Tiziana Life Sciences. Recently, we also successfully demonstrated that nasally administered

Foralumab is not only well-tolerated but also produced the desirable immunological responses. He added that "both oral and

nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits."

are very pleased with the tolerability of both oral and nasally administered Foralumab" added Dr. Tanuja Chitnis, Professor

of Neurology at Harvard Medical School, and study Principal Investigator (PI).

completion of this study is a significant milestone to validate our proprietary technologies of oral and nasal

administration of mAbs, which we believe could potentially be transformational for future development of mAbs therapeutics.

We are excited to note that oral administration was well-tolerated and that the treatment did not result in severe toxicities

that are commonly observed with intravenous (IV) administration of anti-CD3 mAbs. These findings provide the scientific

rationale for our core technologies of oral and nasal formulations of mAb therapeutics, said Dr. Shailubhai, CEO & CSO of

Tiziana Life Sciences.

person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

(formerly NI-0401), the only entirely human anti- CD3 mAb, demonstrated a 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 improved overall

safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2 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. 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.

studies on oral and nasal administration with Anti-CD3 mAbs

and clinical studies have shown that mucosal induction of Tregs by oral or nasal administration of anti-CD3 mAbs is an innovative

approach to treat autoimmune and anti-inflammatory diseases (Kuhn and Weiner 2016). Administration of anti-CD3 antibody orally

in SLJ mice was shown to suppress autoimmune encephalomyelitis and nasally administered anti-CD3 mAbs were shown to ameliorate

disease in an animal model of multiple sclerosis by inducing IL-10+LAP+ ("latency-associated peptide")

T cells, demonstrating oral and nasal anti-CD3 mAbs as a new approach to treat progressive forms of multiple sclerosis and other

types of chronic CNS inflammation. Additionally, mucosal administered anti-CD3 mAbs suppressed lupus in lupus-prone mice ("BWF1")

by inducing IL- 10 and TGF- ("Transforming Growth Factor") dependent mechanisms associated with a suppression

of IL-17 and IL-21 pro-inflammatory cytokines.

Tiziana Life Sciences

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.

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.

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.

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