Tevogen Bio (“Tevogen” or “Tevogen Bio Holdings Inc.”) (Nasdaq:
TVGN), a clinical-stage specialty immunotherapy biotech developing
off-the-shelf, genetically unmodified T cell therapeutics to treat
infectious disease and cancers, shared the company’s ambition to
address the Long COVID crisis as its leadership met with Congress
on Capitol Hill last week.
“It was an honor to meet with congressional teams in Washington,
D.C., to address the urgent challenge of Long COVID and present
Tevogen Bio’s proprietary ExacTcell™ technology as a promising
solution to this escalating crisis, which is impacting both
individual patients and the broader economy," said Ryan Saadi, MD,
MPH, founder and CEO of Tevogen Bio. He continued, "We are pleased
with our rapid progress and notable achievements, including our
precision T cell technology, recently published clinical trial
results, and our robust intellectual property portfolio, all of
which are critical milestones in our efforts to develop lifesaving
immunotherapies for large patient populations."
Within 18 months of its inception, Tevogen Bio advanced its lead
product candidate, TVGN 489, a genetically unmodified,
off-the-shelf investigational T cell therapeutic for acute
SARS-CoV-2 infections, from discovery to the clinical phase.
Tevogen Bio’s leadership highlights its unique business model,
which is both faster and cost-efficient, potentially serving as a
blueprint to drive sustainable innovation and maintain the U.S.'s
competitive edge in the biotech sector. With the ongoing unmet need
for effective treatments of acute SARS-CoV-2 in vulnerable
populations, such as the immunocompromised, those undergoing cancer
treatment, or suffering from Long COVID, Tevogen Bio believes TVGN
489 has the potential to be a breakthrough solution.
Key Achievements:
- In June of 2020, Tevogen Bio is
founded and launched its proprietary ExacTcell technology, designed
to create accessible and disease-specific cellular
immunotherapies.
- Tevogen Bio is granted 3 U.S.
patents by 2022; there are currently 9 additional patents pending,
including 2 for Artificial Intelligence, and 12 international
applications filed.
- Tevogen Bio is recognized as the
highest valued biotech unicorn of 2022, with an independent $4.2
billion valuation.
- By 2023, positive proof-of-concept
clinical trial results are announced for TVGN 489, Tevogen Bio’s
allogeneic CD8+ T cell therapy for high-risk SARS-CoV-2 patients.
No dose-limiting toxicities or significant adverse events were
reported, and secondary endpoints show rapid reduction of viral
load, highlighting the potential of the therapy.
- Tevogen.AI is introduced to create
artificial intelligence solutions for greater patient accessibility
and quicker innovation while decreasing operating cost. Recently,
Tevogen.AI has joined the Microsoft for Startups program gaining
access to experts and resources from a world-leading AI
company.
- On February 15, 2024, Tevogen Bio
celebrates its public debut by ringing the Nasdaq Opening Bell,
marking its first day of trading on the public market.
- Tevogen Bio is now included in the
Russell 3000® Index, reflecting its growing presence and impact in
the biotech industry.
Kirti Desai, CFO of Tevogen Bio, highlights, “We believe
Tevogen's intellectual property assets, including 3 granted
patents, have significant market value that is not currently
reflected in the financial statements of the company. US GAAP rules
relating to valuation of intangible assets do not permit the
company to write up the internally developed intangible assets to
its fair market value. We believe that a proper assessment of the
company's enterprise value should include consideration of its
intellectual property assets.”
Intellectual Property:
Tevogen Bio received two granted patents in December 2021 and
one in January 2022 from the United States Patent and Trademark
Office (USPTO) for Covid-19 Peptide Specific T-Cells and Methods of
Treating and Preventing Covid-19.
- Patent Number 11207401
- Patent Number 11219684
- Patent Number 11191827
In June 2022, a Patent Cooperation Treaty (PCT) application
covering Virus Specific T-Cells and Methods of Treating and
Preventing Viral Infections was published. This application entered
the National Stage in the US, Australia, Canada, Europe, Hong Kong,
and Japan.
- Publication Number WO
2022/125746
In February 2023, a PCT application covering Methods for
Developing CD3+CD8+ Cells Against Multiple Viral Epitopes for
Treatment of Viral Infections Including Variants Evolving to Escape
Previous Immunity was published. This application entered the
National Stage in the US, Australia, Canada, Europe, Japan, Qatar,
Saudi Arabia, and United Arab Emirates.
- Publication Number WO
2023/009770
Tevogen Bio also had two provisional patent applications in
place as of December 2023 for its approach to leveraging artificial
intelligence in expediting target detection to accelerate product
development:
- AI Algorithm to Predict
Immunologically Active HLA-Peptide Complexes
- AI Algorithms to Predict T Cell
Receptor Engagement to Specific HLA+ Peptide Complexes
As of September 2024, applications have also been filed for
Antigen-Specific T Cell Receptor Engineered T Cells (TCR-T) And
Methods of Treating Cancer as well as Tumor Cell Expression of
Viral Antigen by Targeting With Stealth Liposome Or Antibody And
Subsequent Elimination With Viral Specific CTLs.
Tevogen’s leadership believes the overall value of the company
is connected to both its intellectual property portfolio and the
progress of its clinical and preclinical programs. The leadership
plans to provide shareholders with an update on the fair market
value of these assets as soon as they become available.
About Tevogen Bio
Tevogen is a clinical-stage specialty immunotherapy company
harnessing CD8+ cytotoxic T lymphocytes, to develop off-the-shelf,
genetically unmodified T cell therapeutics to treat infectious
disease and cancers, 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 numerous pending patents,
two of which are related to artificial intelligence.
Tevogen is driven by a team of experienced industry leaders and
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;
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: 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 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; 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; 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;
the ability to develop, license or acquire new therapeutics; 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; uncertainties inherent in the execution, cost,
and completion of preclinical studies and clinical trials; risks
related to regulatory review, approval and commercial development;
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 subsequent 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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