Tevogen Bio Confirms Ongoing Efficacy of TVGN 489, Its Investigational Allogeneic Off-the-Shelf Immunotherapy, Against Dominant FLiRT Strains of SARS-CoV-2
2024年6月7日 - 4:52AM
Tevogen Bio Holdings Inc. (“Tevogen” or “Tevogen Bio”) (Nasdaq:
TVGN), a clinical-stage specialty immunotherapy biotech pioneer
developing off-the-shelf, genetically unmodified T cell
therapeutics in oncology, neurology, and virology, 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 FLiRT strains of
SARS-CoV-2 based on a review of this variant’s protein sequences.
Named FLiRT to reflect amino acid changes occurring in the spike
protein, these Omicron subvariants are descendent from JN.1, the
previously dominant strain in the US.
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, show that 95% of these CTLs remain active against FLiRT
variants, including KP.2, the current dominant strain.
In January 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 reduce
the mortality and morbidity burden of millions of Long Covid
patients, where little progress has been made in developing
treatments for this condition despite significant government
funding.”
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 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 is driven by a team of highly experienced industry
leaders and distinguished scientists with drug development and
global product launch experience. Tevogen’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,
including without limitation statements relating to: Tevogen’s
development of, the potential benefits of, and patient access to
its product candidates for the treatment of infectious diseases,
cancer and neurological disorders, including TVGN 489 for the
treatment of COVID-19 and Long COVID; Tevogen’s ability to develop
additional product candidates, including through use of Tevogen’s
ExacTcell platform; the anticipated benefits of ExacTcell;
expectations regarding Tevogen’s future clinical trials; the
healthcare and biopharmaceutical industries; and Tevogen’s ability
to generate revenue in the future. Forward-looking statements can
sometimes be identified by words such as “may,” “could,” “would,”
“expect,” “anticipate,” “possible,” “potential,” “goal,”
“opportunity,” “project,” “believe,” “future,” and similar words
and expressions or their opposites. These statements are based on
management’s expectations, assumptions, estimates, projections and
beliefs as of the date of this press release and are subject to a
number of factors that involve known and unknown risks, delays,
uncertainties and other factors not under the company’s control
that may cause actual results, performance or achievements of the
company to be materially different from the results, performance or
other expectations expressed or implied by these forward-looking
statements.
Factors that could cause actual results, performance, or
achievements to differ from those expressed or implied by
forward-looking statements include, but are not limited to:
uncertainties inherent in the execution, cost, and completion of
preclinical studies and clinical trials; risks related to
regulatory review, and approval and commercial development; risks
related to the ability to develop, license or acquire new
therapeutics; the effect of the recent business combination with
Semper Paratus Acquisition Corporation (the “Business Combination”)
on Tevogen’s business relationships, operating results, and
business generally; the outcome of any legal proceedings that may
be instituted against Tevogen related to the Business Combination;
changes in the markets in which Tevogen 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 may not be able to execute its
growth strategies or may experience difficulties in managing its
growth and expanding operations; costs related to the Business
Combination and the failure to realize anticipated benefits of the
Business Combination; the failure to achieve Tevogen’s
commercialization and development plans, and identify and realize
additional opportunities, which may be affected by, among other
things, competition, the ability of Tevogen to grow and manage
growth economically and hire and retain key employees; the risk
that Tevogen 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; that Tevogen will need to raise additional capital to
execute its business plan, which may not be available on acceptable
terms or at all; the risk of regulatory lawsuits or proceedings
relating to Tevogen’s business; risks associated with intellectual
property protection; Tevogen’s limited operating history; and those
factors discussed or incorporated by reference in Tevogen’s Annual
Report on Form 10-K and filings with the SEC.
You should not place undue reliance on forward-looking
statements, which speak only as of the date they are made. Tevogen
undertakes no obligation to update any forward-looking statements,
except as required by applicable law.
Contacts
Tevogen Bio CommunicationsT: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com
Tevogen Bio (NASDAQ:TVGN)
過去 株価チャート
から 8 2024 まで 9 2024
Tevogen Bio (NASDAQ:TVGN)
過去 株価チャート
から 9 2023 まで 9 2024