Immunovaccine and Pfenex Report Positive Results from Single Dose Anthrax Vaccine Studies
01 Avril 2014 - 2:05PM
Marketwired
Immunovaccine and Pfenex Report Positive Results from Single Dose
Anthrax Vaccine Studies
Data demonstrates 100% protection against a lethal anthrax
challenge in animals after vaccination with as little as 0.33
microgram of mutant recombinant Protective Antigen; Dose response
observed in the first 28 days following vaccination
HALIFAX, NOVA SCOTIA and SAN DIEGO, CALIFORNIA--(Marketwired -
Apr 1, 2014) - Immunovaccine Inc. ("Immunovaccine")
(TSX-VENTURE:IMV) and Pfenex Inc. ("Pfenex") today announced
positive results from anthrax challenge studies in rabbits using
Pfenex's mutant recombinant Protective Antigen (mrPA) formulated
with Immunovaccine's DepoVax™ delivery system. The studies showed
that animals administered a vaccine containing mrPA formulated in
DepoVax were protected against a lethal anthrax challenge at a
range of antigen doses.
DepoVax containing between 0.1 and 9 micrograms of mrPA was
tested as a single dose in rabbits to determine the level of
neutralizing antibodies produced by the vaccine and its ability to
protect against a lethal dose of the anthrax causing bacteria
(B. anthracis). All animals vaccinated with a single dose
of mrPA - DepoVax containing as little as one third of a microgram
of antigen were protected from anthrax infection. Four out of five
animals vaccinated with mrPA - DepoVax containing one tenth of a
microgram of antigen were also protected.
A dose response was observed in the first 28 days following
vaccination with higher amounts of mrPA formulated in DepoVax
producing higher levels of neutralizing antibodies during this
period. In rabbits immunized with a DepoVax vaccine, antibody
titers generally plateaued within 28 days and persisted until at
least day 70 when animals were exposed to the disease agent. The
neutralizing titers measured on day 28 suggest that animals may be
protected within one month of a single immunization.
Further studies will be designed to continue to evaluate the
potential of DepoVax-based vaccines to offer rapid protection with
a single dose.
"The positive data from this latest study highlight the
potential for the DepoVax platform to enable rapid response
vaccines to combat bioterrorism," stated Dr. Marc Mansour, chief
operating officer of Immunovaccine. "The ability to decrease the
antigen content and still produce lasting protective antibody
titers that protect from anthrax challenge following one
vaccination potentially demonstrates the immune enhancing
characteristics of DepoVax."
"Pfenex is excited to be collaborating with Immunovaccine in
pursuit of a stable, fast acting, dose sparing and antigen sparing
vaccine candidate that will meet the needs of the US Federal
Government," stated Dr. Bert Liang, chief executive officer of
Pfenex.
Previously reported rabbit and non-human primate studies
suggested that DepoVax may enable a single dose rPA anthrax
vaccine. It is now confirmed that a single dose of mrPA formulated
in DepoVax is protective in the rabbit model. These studies,
conducted under the National Institute of Allergy and Infectious
Diseases' (NIAID's) preclinical services program
(HHSN272201000022I/HHSN27200001), are intended to evaluate
Immunovaccine's DepoVax adjuvanting technology and advance the
development of next generation bio-defense vaccines.
About
DepoVax™
DepoVax™ is a patented formulation that provides controlled and
prolonged exposure of antigens plus adjuvant to the immune system,
resulting in a strong, specific and sustained immune response with
the capability for single-dose effectiveness. The DepoVax platform
possesses impressive flexibility, allowing it to work with a broad
range of target antigens in various therapeutic applications. The
technology is also commercially scalable, with potential for years
of stability and ease of use in the clinic.
About Pfenex
mrPA
Through the use of its proprietary protein production platform
technology, Pfēnex Expression Technology™, Pfenex's mrPA is
produced by using a phenotypically unique protease-deficient strain
of P. fluorescens expressing a B. anthracis
protective antigen variant lacking specific protease cleavage
sites. Those protease cleavage sites have previously been
implicated in stability issues associated with the antigen. The
combination of the proprietary production strain and rPA variant
has resulted in a robust scalable production process capable of
producing a stable antigen. The development of the Pfenex mrPA
product is currently being funded by Pfenex's prime contract
(HHS0100201000045C) with the Biomedical Advanced Research and
Development Authority (BARDA) within the Office of the Assistant
Secretary for Preparedness and Response in the U.S. Department of
Health and Human Services.
About
Immunovaccine
Immunovaccine Inc. develops cancer immunotherapies and
infectious disease vaccines based on the Company's DepoVax™
platform, a patented formulation that provides controlled and
prolonged exposure of antigens and adjuvant to the immune system.
Immunovaccine has advanced two T cell activation therapies for
cancer through Phase I human clinical trials. Lead cancer vaccine
therapy, DPX-Survivac, is expected to enter Phase II clinical
studies in both ovarian cancer and glioblastoma (brain cancer). The
Company is also advancing an infectious disease pipeline including
innovative vaccines for respiratory syncytial virus (RSV) and
anthrax.
Connect at www.imvaccine.com
About Pfenex
Inc.
Pfenex Inc. is a clinical stage biotechnology company developing
biosimilars and innovative vaccines to address unmet and growing
global healthcare needs. Utilizing the company's core technology,
Pfēnex Expression Technology™ for recombinant protein
expression, Pfenex is able to rapidly develop and produce high
quality biopharmaceuticals. In addition, Pfenex also produces and
markets research proteins and reagent proteins for the research and
drug development community through its Reagent Proteins division.
For more information please visit www.pfenex.com.
This press release contains forward-looking information
under applicable securities law. All information that addresses
activities or developments that we expect to occur in the future,
is forward-looking information. Forward-looking statements are
based on the estimates and opinions of management on the date the
statements are made. However, they should not be regarded as a
representation that any of the plans will be achieved. Actual
results may differ materially from those set forth in this press
release due to risks affecting the company, including access to
capital, the successful completion of clinical trials and receipt
of all regulatory approvals. Immunovaccine Inc. assumes no
responsibility to update forward-looking statements in this press
release except as required by law.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Immunovaccine Inc.Marc MansourChief Operating Officer(902)
492-1819mmansour@imvaccine.comVida Strategic Partners (media)Tim
Brons(415) 675-7402tbrons@vidasp.comPfenex Inc.Cassidy BradySr.
Marketing Manager(858) 344-7207cbrady@pfenex.com
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