Tevogen Bio Announces Publication of Positive Phase I Clinical Trial Results for TVGN 489 in Blood Advances
25 Junio 2024 - 7:05AM
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, reports
publication of its phase I clinical trial data of TVGN 489, its
investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T
lymphocytes (CTLs) immunotherapy by the journal Blood Advances.
Key Observations:
- Interventional arm patients, totaling twelve high-risk
individuals, 50% of whom were immunocompromised, and 40% of whom
were immunocompromised due to preexisting cancers, received a
single infusion of one of four escalating doses of TVGN 489, a
product containing 68.5% SARS-CoV-2-specific CD8+ CTLs/total
cells.
- Symptom improvement and resolution in treatment arm patients
were compared to an observational group of eighteen patients who
received standard care, making a total of 30 study
participants.
- TVGN 489 was well-tolerated at all four doses tested.
- Nasal swab PCR data showed 88% or greater viral elimination in
92% of patients by day +4 and > 99% viral elimination in all
patients by day +14.
- No progression of disease or the development of Long COVID was
observed in the treatment group, despite the prevalence of
immunocompromised patients.
- TVGN 489 did not interfere with the development of endogenous
anti-SARS-CoV-2 humoral or cellular responses.
- T-cell receptor beta (TCRβ) analysis comparing TVGN 489
responses derived from the CTL donor versus recipients showed
persistence of donor-derived CTLs through the end of the 6-month
follow-up period.
An unanticipated finding was the persistence of the
TVG-489 CTLs in all patients tested through the end of the 6-month
follow-up period. “Due to the high degree of immune mismatch
between the treated patients and the CTL donor, we suspected that
after an initial reaction against the SARS-CoV-2 virus, the CTLs
would have been quickly eliminated by the patients. Persistence of
allogeneic T-cells has been associated with disease control in many
settings, therefore, the further exploration of the reason for the
persistence and the potential implications is important,” said Neal
Flomenberg, Tevogen’s Chief Scientific Officer.
“We are excited by the outcomes of the phase I trial and are
looking forward to both confirming the safety of TVGN 489 and
further testing their efficacy in later stage trials in elderly and
immune compromised patients with COVID-19 who continue to have
higher risk outcomes,” said Dr Dolores Grosso, DNP, Tevogen’s
Global Clinical Development Lead.
“The full potential of T cell therapies has yet to be realized.
We believe that our allogeneic, precision T cell technology
platform, ExacTcell™, represents a significant scientific
breakthrough with the potential to mainstream cell therapy, through
a new class of off-the-shelf T cell therapies, manufactured and
stored for immediate use, with diverse applications across
virology, oncology, and neurology,” said Ryan Saadi, CEO of Tevogen
Bio.
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, nine pending US and twelve ex-US 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: expectations
regarding the healthcare and biopharmaceutical industries;
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;
Tevogen’s manufacturing plans; 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,”
“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 presentation 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.
These factors include, but are not limited to: that Tevogen will
need to raise additional capital to execute its business plan,
which may not be available on acceptable terms or at all;
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
associated with intellectual property protection; 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; costs
related to the Business Combination and the failure to realize
anticipated benefits of the Business Combination; 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; the risk that Tevogen may not be able to develop and
maintain effective internal controls; 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; the ability to develop, license or acquire new
therapeutics; the risk of regulatory lawsuits or proceedings
relating to Tevogen’s business; Tevogen’s limited operating
history; and those factors discussed in Tevogen’s Annual Report on
Form 10-K and other 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
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