Study Results to be Presented at World Vaccine Congress
FORT COLLINS, Colorado and VIENNA, Austria – April 17, 2025 – Vivaldi Biosciences Inc., a clinical-stage biotechnology company developing nasal spray vaccines for viral respiratory diseases, will present data on the potential of its DeltaFLU universal influenza vaccine to block virus transmission at the World Vaccine Congress in Washington, DC on April 24.
Amy
Aspelund, Vice President of Research and Development at Vivaldi Biosciences,
will present data at the World Vaccine Congress showing that immunization with DeltaFLU
blocks transmission of highly divergent influenza type A and type B viruses.
The studies were conducted in ferrets, a well-characterized animal model of
influenza infection and immunity in humans.
A
universal influenza vaccine that both protects against all influenza virus
strains and blocks transmission would be a significant advance in preventing
influenza and reducing the disease burden, especially in the event of a
pandemic. Influenza viruses are transmitted from an infected to a susceptible
person mainly by airborne droplets produced by sneezing or coughing. An
infected individual can spread influenza even before symptoms of illness begin.
Influenza can spread rapidly in settings where people are in close proximity.
Seasonal influenza infects up to 10% of adults and 30% of children worldwide
every year, leading to millions of cases of severe illness and up to 650,000
deaths annually. An influenza pandemic could cause millions of deaths.
Vivaldi
is developing DeltaFLU to protect against all influenza virus strains that
cause disease in humans: all seasonal influenza type A and B strains, and
emerging influenza virus strains with pandemic potential. DeltaFLU
vaccine strains have been successfully evaluated in four clinical trials.
Additional Phase 1 and Phase 1/2 studies of DeltaFLU, funded by the NIAID and
European Union, are scheduled for 2025. An EU-funded Phase 2 clinical challenge
study planned for 2027. The ferret transmission studies confirmed previous
findings showing DeltaFLU induces a broad immune response against influenza
type A groups 1 and 2 viruses and type B viruses. The studies also confirmed
earlier work showing that DeltaFLU protects immunized ferrets against challenge
with broadly divergent type A and B strains, i.e., universal protection. Administered
as a nasal spray, DeltaFLU is composed of genetically attenuated influenza
vaccine strains from which the NS1 gene is deleted. Deletion of NS1 results in
the ability of DeltaFLU to induce interferon, conferring a self-adjuvant effect
and activating multiple mechanisms of the immune response, including broadly
cross-neutralizing antibodies in the nasal passages, systemic antibodies and T
cells. The rapid immune response in the nasal passages creates
a first line of defense at the point of entry of infectious viruses. Distinct
from live attenuated influenza vaccines licensed and in development, DeltaFLU
vaccine strains are replication-deficient. DeltaFLU vaccine strains do not form
viral progeny and there is no detectable shedding of vaccine virus from
recipients. About Vivaldi Biosciences Vivaldi is
developing intranasal vaccines for superior protection against respiratory
diseases. The company’s clinical-stage vaccines are the DeltaFLU universal
influenza vaccine, for protection against all influenza A and B strains; and
DelNS1 H5N1, a Phase 2-ready vaccine for protection against highly pathogenic influenza
H5N1 strains with pandemic potential. The company’s
Delta-19 combination vaccine for Covid-19 and influenza is in preclinical
development. Vivaldi’s Vero cell-based vaccine manufacturing system uses
patented advances in production and purification for high yields and excellent
purity. Vivaldi is a venture-backed company with operations at the Research
Innovation Center at Colorado State University, Fort Collins, Colorado, and in
Vienna, Austria. NGN Capital LLC is the company’s lead investor. Learn more at
www.vivaldibiosciences.com. Connect with Vivaldi Biosciences on Linkedin and
Twitter. Contact Bill Wick, CEO, Vivaldi Biosciences Tel: +1 650-400-8915 bill.wick@vivaldibiosciences.com
Forward-Looking Statements
This release contains forward-looking statements relating to
Vivaldi Biosciences, which are not historical facts and are forward-looking
statements within the meaning of the Private Securities Litigation Reform Act
of 1995. All statements included in this communication concerning activities,
events or developments that we expect, believe or anticipate will or may occur
in the future are forward-looking statements. Our actual results, performance
or achievements may differ materially from those expressed or implied by these
forward-looking statements. Forward-looking statements are based on current expectations
and projections about future events and involve known and unknown risks,
uncertainties and other factors, including, but not limited to, the following:
the uncertainty of clinical success and of obtaining regulatory approvals, the
difficulty of predicting FDA approvals, acceptance and demand for new vaccines
and other pharmaceutical products, product efficacy or safety concerns
resulting in product recalls or regulatory action, the impact of competitive
products and pricing, new product development and launch, reliance on key
strategic alliances, availability of raw materials, availability of additional
intellectual property rights, availability of future financing sources, the
ability to obtain future funding and to obtain such funding on commercially
reasonable terms, the regulatory environment and other risks the Company may
identify from time to time in the future. These factors are not necessarily all
of the important factors that could cause our actual results, performance or
achievements to differ materially from those expressed in or implied by any of
our forward-looking statements. These forward-looking statements speak only as
of the date of this communication and we undertake no obligation to update or
revise any forward-looking statement, whether as a result of new information,
future events and developments or otherwise, except as required by law. If we
update one or more forward-looking statements, no inference should be drawn
that we will make additional updates with respect to those or other
forward-looking statements. This press release should not constitute an offer
to sell or a solicitation of an offer to buy securities.
