Cell Therapy Company Tevogen Bio Holdings Inc. Prepares to Launch Crucial Genetic Predisposition Study in Preparation to Investigate the Potential of TVGN 489 to Address Critical Unmet Need for Long COVID Treatment
February 21 2024 - 7:00AM
Business Wire
Tevogen Bio Holdings Inc. ('Tevogen Bio') (Nasdaq: TVGN)
- Tevogen’s ExacTcell platform was developed to harness the
killing ability of naturally occurring cytotoxic T lymphocytes
(CTLs), against viral and malignant targets.
- TVGN 489, a CTL therapy produced by the ExactTcell platform,
contains CTLs recognizing multiple protein targets across the
SARS-CoV-2 genome. These cells were well tolerated in a completed
proof of concept clinical trial in high-risk patients with acute
COVID-19, with later stage studies planned in this area.
- Tevogen plans to assess whether TVGN 489 cells can rapidly
eliminate symptoms of Long Covid. To facilitate the development of
a Long Covid treatment trial, Tevogen will launch a preliminary
study in Q1 2024 to assess whether the development of Long COVID is
associated with a key component of an individual’s immune system
known as Human Leukocyte Antigens (HLA).
- TVGN 489 CTLs work in conjunction with HLA molecules to
recognize and destroy viral targets. HLA types vary from person to
person and are known to influence degrees of risk in other
infectious settings. Specific HLA types may be associated with more
or less protection against a particular infection.
Prior to launching the Long COVID clinical trial, Tevogen seeks
to address whether Long COVID occurs more commonly with certain HLA
types and less commonly with others, or whether Long COVID occurs
randomly in the population regardless of HLA. This effort will help
Tevogen generate CTL products recognizing the HLA types that are
most commonly associated with Long Covid, if a relationship between
Long Covid and HLA type is identified, with the goal of allowing a
Long COVID treatment trial to be designed and completed
expeditiously.
“We have spent significant resources and time identifying TVGN
489’s targets from across the entire COVID genome. These have
remained remarkably durable over the last 4 and a half years. I am
highly optimistic that TVGN 489 will offer a meaningful solution
for both acute and Long COVID patients,” said Neal Flomenberg, MD,
Tevogen’s Chief Scientific Officer.
“Generating this information will provide important insights
into the immunologic factors that contribute to Long COVID
development and will greatly facilitate the treatment trial we
expect to follow,” added Shannon Rudolph, Clinical Scientist at
Tevogen
About Tevogen Bio
Tevogen Bio is a clinical-stage specialty immunotherapy company
harnessing one of nature’s most powerful immunological weapons,
CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically
unmodified precision T cell therapies for the treatment of
infectious diseases, cancers, and neurological disorders, aiming to
address the significant unmet needs of large patient populations.
Tevogen leadership believes that sustainability and commercial
success in the current era of healthcare rely on ensuring patient
accessibility through advanced science and innovative business
models. Tevogen has reported positive safety data from its
proof-of-concept clinical trial, and its key intellectual property
assets are wholly owned by the company, not subject to any
third-party licensing agreements. These assets include granted
patents and pending patents, two of which are related to artificial
intelligence.
Forward-Looking Statements
This press release contains certain statements that are not
historical facts and are forward-looking statements within the
meaning of the federal securities laws, including without
limitation statements regarding the anticipated benefits of the
recent business combination with Semper Paratus Acquisition
Corporation (the “Business Combination”), the future financial
condition and performance of Tevogen Bio, and the product
candidates, products, markets, and expected future performance and
market opportunities of Tevogen Bio. These forward-looking
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Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties.
Factors that could cause actual future events to differ
materially from the forward-looking statements in this
communication include without limitation: (i) the effect of the
announcement of the Business Combination on Tevogen Bio’s business
relationships, operating results, and business generally; (ii) the
outcome of any legal proceedings that may be instituted against
Tevogen Bio related to the Merger Agreement or the Business
Combination ; (iii) changes in the markets in which Tevogen Bio
competes, including with respect to its competitive landscape,
technology evolution, or regulatory changes; (iv) changes in
domestic and global general economic conditions; (v) risk that
Tevogen Bio may not be able to execute its growth strategies or may
experience difficulties in managing its growth and expanding
operations; (vi) risk that Tevogen Bio may not be able to develop
and maintain effective internal controls; (vii) costs related to
the Business Combination and the failure to realize anticipated
benefits of the Business Combination or to realize estimated pro
forma results and underlying assumptions, including with respect to
estimated shareholder redemptions; (viii) the failure to recognize
the anticipated benefits of the Business Combination and to achieve
Tevogen Bio’s commercialization and development plans, and identify
and realize additional opportunities, which may be affected by,
among other things, competition, the ability of Tevogen Bio to grow
and manage growth economically and hire and retain key employees;
(ix) the risk that Tevogen Bio may fail to keep pace with rapid
technological developments to provide new and innovative products
and services or make substantial investments in unsuccessful new
products and services; (x) the ability to develop, license or
acquire new therapeutics; (xi) the risk that Tevogen Bio will need
to raise additional capital to execute its business plan, which may
not be available on acceptable terms or at all; (xii) the risk of
product liability or regulatory lawsuits or proceedings relating to
Tevogen Bio’s business; (xiii) uncertainties inherent in the
execution, cost, and completion of preclinical studies and clinical
trials; risks related to regulatory review, and approval and
commercial development; (xiv) risks associated with intellectual
property protection; (xv) Tevogen Bio’s limited operating history;
and (xvi) those factors discussed in Tevogen Bio’s filings with the
SEC and that are contained in the Proxy Statement/Prospectus
relating to the Business Combination.
The foregoing list of factors is not exhaustive. You should
carefully consider the foregoing factors and the other risks and
uncertainties described in the “Risk Factors” section of the Proxy
Statement/Prospectus and other documents to be filed by Tevogen Bio
from time to time with the SEC. These filings identify and address
other important risks and uncertainties that could cause actual
events and results to differ materially from those contained in the
forward-looking statements. Forward-looking statements speak only
as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and while Tevogen Bio
may elect to update these forward-looking statements at some point
in the future, they assume no obligation to update or revise these
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by applicable
law.
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