Vaxart Announces Agreement with hVIVO to Develop World’s First Human Omicron Challenge Model
June 30 2022 - 8:00AM
Vaxart, Inc. (Nasdaq: VXRT) today announced an agreement with hVIVO
Services Limited, a subsidiary of Open Orphan plc (AIM: ORPH) under
which hVIVO will conduct a characterization study and, if
successful, develop a human challenge model based on the Omicron
variant of SARS-CoV-2 with the intent to conduct a subsequent Phase
II Human Challenge Trial (HCT) of Vaxart’s oral COVID-19 vaccine
pill candidate.
Vaxart is developing an oral COVID-19 vaccine
pill and is the first company to progress to a Phase II clinical
trial with an oral candidate. Vaxart is now also the first company
to announce the intent to test a vaccine candidate through a
COVID-19 human challenge study using the now prevalent Omicron
variant, rather than the original Wuhan strain.
hVIVO is a specialist contract research
organization (CRO) and global leader in testing infectious and
respiratory disease products using HCTs.
“We are excited at the prospect of testing our
vaccine candidates in a human Omicron challenge model particularly
given the preclinical data we reported earlier this month that
showed two of our COVID-19 vaccine constructs could protect against
the Omicron BA.1 variant. A human challenge study of our oral
COVID-19 vaccine pill candidate against the Omicron variant of
SARS-CoV-2 is the most rapid and direct way to assess the efficacy
of this candidate against a highly prevalent viral strain,” said
Dr. James Cummings, Vaxart’s Chief Medical Officer.
“hVIVO has pioneered COVID-19 characterization
and the Omicron human challenge model, and the use of this model in
our planned Phase II HCT can rapidly generate robust, controlled
data on the ability of our COVID-19 vaccine candidate to prevent
infection and the development of symptomatic disease, as well as
its effect on viral shedding, which plays a critical role in the
spread of infection from one person to another. The results of this
study will inform the next steps in the development of our COVID-19
vaccine candidate, which we believe has the potential to transform
personal and public health approaches to controlling the global
pandemic,” added Dr. Cummings.
“We are proud to be developing the world’s first
Omicron human challenge model and to welcome Vaxart as the first
client of this program,” said Yamin ‘Mo’ Khan, Chief Executive
Officer of Open Orphan. “The successful completion of the world’s
first COVID-19 characterization, which was published in Nature
Medicine earlier this year, has given our customers the confidence
to move forward with the less severe yet more infective Omicron
challenge model.”
Following manufacture of the challenge virus,
hVIVO will conduct a characterization study to establish a dose of
the Omicron challenge virus that will cause a safe and reliable
infection in healthy volunteers. The study will enroll healthy male
and female volunteers who have previously been vaccinated against
or infected with SARS-CoV-2, with no known risk factors for severe
COVID-19 and low levels of serum neutralizing antibodies (and
therefore still likely to become infected following inoculation).
Subject to the successful completion of the characterization study
and receipt of relevant regulatory approvals, the Omicron human
challenge trial is expected to begin in 2023.
About Vaxart Vaxart is a
clinical-stage biotechnology company developing a range of oral
recombinant vaccines based on its proprietary delivery platform.
Vaxart vaccines are designed to be administered using pills that
can be stored and shipped without refrigeration and eliminate the
risk of needle-stick injury. Vaxart believes that its proprietary
pill vaccine delivery platform is suitable to deliver recombinant
vaccines, positioning the company to develop oral versions of
currently marketed vaccines and to design recombinant vaccines for
new indications. Vaxart’s development programs currently include
pill vaccines designed to protect against coronavirus, norovirus,
seasonal influenza, and respiratory syncytial virus (RSV), as well
as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s
first immune-oncology indication. Vaxart has filed broad domestic
and international patent applications covering its proprietary
technology and creations for oral vaccination using adenovirus and
TLR3 agonists.
About hVIVOA subsidiary of Open
Orphan plc (AIM: ORPH), hVIVO is an industry leading partner
providing end-to-end human challenge trial services to help
accelerate drug and vaccine development in respiratory and
infectious disease. With a leading portfolio of human challenge
models, hVIVO has decades of experience and expertise in conducting
human challenge trials as well as challenge agent manufacture and
clinical characterization across a range of respiratory viruses
including various strains of influenza, respiratory syncytial virus
(RSV), human rhinovirus (hRV – common cold virus), as well as the
initial circulating SARS-CoV-2 virus and variants which have since
emerged. hVIVO leads the Challenge Agent Manufacture Consortium,
which has developed international standards that pertain to
challenge agent manufacture and storage, to ensure safety, quality
and consistency. hVIVO runs its studies from its state-of-the-art
quarantine facilities in London with specialized on-site virology
and immunology laboratories, the Company leverages its unique
FluCamp clinical trial recruitment capacity to recruit volunteers /
patients for its studies.
Note Regarding Forward-Looking
Statements This press release contains
forward-looking statements that involve substantial risks and
uncertainties. All statements, other than statements of historical
facts, included in this press release regarding Vaxart's strategy,
prospects, plans and objectives, results from preclinical and
clinical trials, commercialization agreements and licenses, and
beliefs and expectations of management are forward-looking
statements. These forward-looking statements may be accompanied by
such words as "should," "believe," "could," "potential," "will,"
"expected," “anticipate,” "plan," and other words and terms of
similar meaning. Examples of such statements include, but are not
limited to, statements relating to Vaxart's ability to develop and
commercialize its product candidates, including its vaccine booster
products; Vaxart's expectations regarding clinical results and
trial data; and Vaxart's expectations with respect to the
effectiveness of its product candidates. Vaxart may not actually
achieve the plans, carry out the intentions, or meet the
expectations or projections disclosed in the forward-looking
statements, and you should not place undue reliance on these
forward-looking statements. Actual results or events could differ
materially from the plans, intentions, expectations, and
projections disclosed in the forward-looking statements. Various
important factors could cause actual results or events to differ
materially from the forward-looking statements that Vaxart makes,
including uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement, and/or completion dates for clinical trials,
regulatory submission dates, regulatory approval dates, and/or
launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from the clinical studies; decisions by regulatory
authorities impacting labeling, manufacturing processes, and safety
that could affect the availability or commercial potential of any
product candidate, including the possibility that Vaxart's product
candidates may not be approved by the FDA or non-U.S. regulatory
authorities; that, even if approved by the FDA or non-U.S.
regulatory authorities, Vaxart's product candidates may not achieve
broad market acceptance; that a Vaxart collaborator may not attain
development and commercial milestones; that Vaxart or its partners
may experience manufacturing issues and delays due to events
within, or outside of, Vaxart's or its partners' control;
difficulties in production, particularly in scaling up initial
production, including difficulties with production costs and
yields, quality control, including stability of the product
candidate and quality assurance testing, shortages of qualified
personnel or key raw materials, and compliance with strictly
enforced federal, state, and foreign regulations; that Vaxart may
not be able to obtain, maintain, and enforce necessary patent and
other intellectual property protection; that Vaxart's capital
resources may be inadequate; Vaxart's ability to resolve pending
legal matters; Vaxart's ability to obtain sufficient capital to
fund its operations on terms acceptable to Vaxart, if at all; the
impact of government healthcare proposals and policies; competitive
factors; and other risks described in the "Risk Factors" sections
of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart
does not assume any obligation to update any forward-looking
statements, except as required by law.
Contacts |
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Vaxart Media
Relations: |
Investor
Relations: |
Mark Herr |
Andrew Blazier |
Vaxart,
Inc. |
FINN Partners |
mherr@vaxart.com |
IR@vaxart.com |
(203) 517-8957 |
(646)
871-8486 |
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