Tevogen Bio Reports Its Investigational SARS-CoV-2 Specific T Cell Therapy, TVGN-489, Retains Activity Against the Dominant JN.1 Variant
March 20 2024 - 7:00AM
Business Wire
Tevogen Bio Holdings ('Tevogen Bio') (Nasdaq: TVGN), today
announced TVGN 489, its investigational allogeneic SARS-CoV-2
specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy for
treatment of COVID-19 in high-risk patients and Long COVID, retains
activity against the currently dominant and highly mutated JN.1
strain based on a review of this variant’s protein sequences.
TVGN 489 contains Cytotoxic T lymphocytes that recognize
multiple SARS-CoV-2 proteins, or peptides. TVGN 489’s peptide
targets have been preserved in all previously studied COVID
strains. Continuing surveillance by Tevogen Bio of SARS-CoV-2
variants, including the currently dominant JN.1 strain and newer
JN.1 strains, show that 96% of these CTLs remain active against the
current circulating variants.
In January of 2023, Tevogen reported positive phase I study
results in which high-risk patients with the delta, omicron 1, and
omicron 2 variants of COVID-19 received TVGN 489, manufactured for
the trial in May of 2021. In addition to no dose-limiting
toxicities or significant treatment-related adverse events being
observed in the treatment arm, all patients regardless of variant
experienced prompt clinical improvement and a reduced amount of
virus in their nasal swabs (>99 to 100% in all patients) within
14 days. “These findings will be further assessed in planned
later-stage trials and TVGN 489 will continue to be monitored for
target preservation in emerging SARS-CoV-2 variants,” said Dr
Dolores Grosso, DNP, Tevogen’s Global Clinical Development
Lead.
"We remain committed to developing therapeutic solutions for
patients who are highly vulnerable to developing poor outcomes when
infected with SARS-CoV-2," said Tevogen CEO Dr. Ryan Saadi. "I am
also highly optimistic about the potential of TVGN 489 to bring
much needed relief to millions of Long Covid patients," he
added.
TVGN 489 is manufactured using the ExacTcell platform in which
numerous peptides from across a viral genome are selected as
targets for the CTLs, mitigating reductions in cytotoxicity from
the loss of one target from mutation. In the case of SARS-CoV-2,
the entire COVID-19 genome as opposed to just the Spike protein is
targeted. The preservation of T-cell targets across nearly five
years of viral evolution avoids the need to make frequent changes
to the formulation of TVGN 489 and stands in contrast to the loss
of monoclonal antibody targets, which has happened far more rapidly
in a number of cases.
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 three
granted patents and twelve pending patents, two of which are
related to artificial intelligence.
Tevogen Bio is driven by a team of highly experienced industry
leaders and distinguished scientists with drug development and
global product launch experience. Tevogen Bio’s leadership believes
that accessible personalized therapeutics are the next frontier of
medicine, and that disruptive business models are required to
sustain medical innovation.
Forward Looking Statements
This press release contains certain forward-looking statements
relating to the Tevogen Bio and its business, including without
limitation statements regarding the product candidates, products,
markets, and expected future performance and market opportunities
of Tevogen Bio, Tevogen Bio’s clinical trial plans, and future
target preservation for TVGN 489. These statements are based on
management’s current expectations and beliefs as of the date of
this release and are subject to known and unknown risks and
uncertainties that may cause actual results, performance or
achievements to be materially different from the results,
performance or other expectations expressed or implied by these
forward-looking statements. Forward-looking statements can
sometimes be identified by words such as “may,” “will,” “should,”
“intend,” “expect,” “believe,” “potential,” and “possible,” or
their negatives or comparable terminology, as well as other words
and expressions referencing future events, conditions, or
circumstances. In any forward-looking statement in which Tevogen
Bio expresses an expectation or belief as to future results, there
can be no assurance that the statement or expectation or belief
will be achieved. Various factors may cause differences between
Tevogen Bio’s expectations and actual results, including, among
others: changes in the markets in which Tevogen Bio competes,
including with respect to its competitive landscape, technology
evolution, or regulatory changes; changes in domestic and global
general economic conditions; the risk that Tevogen Bio may not be
able to execute its growth strategies; Tevogen Bio’s limited
operating history; uncertainties inherent in the execution, cost,
and completion of preclinical studies and clinical trials; risks
related to regulatory review and approval and commercial
development, including the risks that changes to TVGN 489’s target
peptides may require additional regulatory approvals and that there
is no guarantee Tevogen Bio will receive such approvals; risks
associated with intellectual property protection; and other risks
related to matters that could affect Tevogen Bio’s future financial
results, including the commercial potential, sales, and pricing of
Tevogen Bio’s products. Except as required by law, Tevogen Bio
undertakes no obligation to update the forward-looking statements
or any of the information in this release, or provide additional
information, and expressly disclaims any and all liability and
makes no representations or warranties in connection herewith or
with respect to any omissions therefrom.
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Tevogen Bio Communications T: 1 877 TEVOGEN, Ext 701
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