Mymetics' Promising HIV Vaccine Candidate Obtains Funding to Begin Study at Texas Biomedical Research Institute
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Mymetics' Promising HIV Vaccine Candidate Obtains Funding to Begin Study at
Texas Biomedical Research Institute
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EPALINGES, SWITZERLAND--(Marketwired - Sep 29, 2014) - Mymetics Corporation
(OTCQB: MYMX), a pioneer in the research and development of virosome-based
vaccines to prevent transmission of human infectious diseases across mucosal
membranes, announced today that its innovative HIV vaccine candidate will enter
a new preclinical trial to confirm excellent results obtained in a previous
trial.
Research to be funded by the Bill & Melinda Gates Foundation
The study will be led by Dr. Ruth Ruprecht, Scientist & Director of the Texas
Biomed AIDS Research Program. This new study follows a successfully completed
smaller study at the Institute of Laboratory Animal Science (ILAS) in Beijing,
China in which a two-component vaccine protected all monkeys against repeated
AIDS virus exposures from persistent infection - an unprecedented result.(1) One
of the vaccine components further showed a strong safety and tolerance profile
in a Phase I clinical trial in human volunteers.(2)
Dr. Ruth Ruprecht said, "Mymetics' HIV vaccine candidate is unique in its
design. First, it uses building blocks from a special part of the HIV envelope
protein, called gp41, and second, it was engineered to stop HIV from crossing
the mucosal barriers - with promising initial results. We are extremely proud
that this study is to be funded by the Bill & Melinda Gates Foundation. We hope
to confirm the previous findings and learn more about this vaccine's mechanism
of action in providing mucosal protection."
Ronald Kempers, CEO of Mymetics, commented, "We are very honored and pleased
about our collaboration with Dr. Ruth Ruprecht, a leading expert in the HIV
field. This collaboration and funding represents an important milestone and
recognition of the work performed by the Mymetics team and partners over the
last years and provides a basis to further develop our HIV vaccine candidate."
He added: "After the signing of the license and collaboration agreement earlier
this year for our Respiratory Syncytial Virus vaccine candidate which is funded
by Astellas Pharma, this new funding and collaboration for our HIV vaccine
candidate is another confirmation that we are on the right track and are
building a strong foundation for success with the right partners."
New trial to begin October 2014
With its HIV-1 (human immunodeficiency virus type 1) vaccine candidate, produced
through its proprietary virosome technology and judicious antigen design,
Mymetics aims to provide both a first line of defense through mucosal protection
as well as a second line of defense against infection through the generation of
blood antibodies. The new trial, to begin in October 2014, will involve 36
rhesus monkeys (n=12 per group) and compare two antigen vaccination regimens
with placebo, followed by intra-vaginal challenges with live virus that carries
an envelope that differs from the one in the vaccine preparation. Results are
expected at the end of 2015.
About HIV and the Mymetics vaccine approach
2.3 million new people were infected by HIV in 2012 while an estimated 1.6
million people died of AIDS in that year (source: WHO). HIV-related illness
remains one of the leading global causes of death and is projected to remain so
in the coming decades. There is as yet no vaccine available against HIV.
However, results of a large Phase III clinical study in Thailand showed a modest
protective effect of 31%, providing encouraging support for the feasibility of
an effective HIV vaccine. The Thai study tested unrelated HIV vaccine candidates
and was reported in September 2009 in the New England Journal of Medicine.
Traditional approaches to creating a vaccine against HIV have aimed to elicit
specific blood antibodies or CTLs (cytotoxic T cells). Both approaches have been
largely unsuccessful to date, and importantly, no or very little protection has
been seen with heterologous challenges, in which the virus strain differs from
the original vaccine. A CTL response has the further drawback of requiring
infection to have already occurred. Despite their importance as protection
mechanisms, neither approach is suitable for protecting against initial mucosal
transmission of HIV.
A vaccine that blocks HIV transmission across mucosal membranes represents a
highly promising approach to preventing HIV infection; however, few studies have
focused on this approach, until now. It builds however on the findings that
certain people are not infected with HIV, even though they are exposed to it
very frequently. Women and men who produce IgA antibodies against the HIV gp41
protein in their mucosal secretions have been found to display resistance to HIV
transmission and infection. Mymetics has used its technology and expertise to
design a vaccine candidate specifically intended to induce a mucosal antibody
response against HIV while also inducing blood antibodies.
About Mymetics
Mymetics Corporation (OTCQB: MYMX) is a Swiss-based biotechnology company
registered in the US and trades on the OTCQB venture stage marketplace for early
stage and developing U.S. and international companies. Companies are current in
their reporting and undergo an annual verification and management certification
process.
Mymetics develops next-generation preventative vaccines for infectious diseases.
Mymetics' core technology and expertise are in the use of virosomes, lipid-based
carriers containing functional fusion viral proteins and natural membrane
proteins, in combination with rationally designed antigens. The company's
vaccines are designed to induce protection against early transmission and
infection, focusing on the mucosal immune response as a first-line defense,
which, for some pathogens, may be essential for the development of an effective
prophylactic vaccine.
Mymetics currently has 5 vaccines in its pipeline: HIV-1/AIDS, intranasal
Influenza, Malaria, Herpes Simplex Virus and the RSV vaccine (out licensed to
ClearPath - Astellas). The company's intranasal Influenza vaccine and the HIV-1
vaccine have successfully completed Phase I clinical trials in healthy human
volunteers. A Phase 1b clinical trial for its Malaria vaccine on children in
Tanzania has been completed, while the HSV vaccine candidate is in the
preclinical phase. For further information, please visit mymetics.com.
About Texas Biomedical Research Institute
Texas Biomed, formerly the Southwest Foundation for Biomedical Research, is one
of the world's leading independent biomedical research institutions dedicated to
advancing health worldwide through innovative biomedical research. Located on a
200-acre campus on the northwest side of San Antonio, Texas, the Institute
partners with hundreds of researchers and institutions around the world to
develop vaccines and therapeutics against viral pathogens causing AIDS,
hepatitis, herpes, hemorrhagic fevers, and parasitic diseases responsible for
malaria, schistosomiasis and Chagas disease. The Institute also has programs in
the genetics of cardiovascular disease, diabetes, obesity, psychiatric disorders
and other diseases. For more information on Texas Biomed, go to
www.TxBiomed.org.
Forward looking statements
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor"
for forward-looking statements, which are identified by the words "believe,"
"expect," "anticipate," "intend," "plan" and similar expressions. The statements
contained herein which are not based on historical facts are forward-looking
statements that involve known and unknown risks and uncertainties that could
significantly affect our actual results, performance or achievements in the
future and, accordingly, such actual results, performance or achievements may
materially differ from those expressed or implied in any forward-looking
statements made by or on our behalf. These risks and uncertainties include, but
are not limited to, risks associated with our ability to successfully develop
and protect our intellectual property, our ability to raise additional capital
to fund future operations and compliance with applicable laws and changes in
such laws and the administration of such laws. See Mymetics' most recent Form
10-K for a discussion of such risks, uncertainties and other factors. Readers
are cautioned not to place undue reliance on these forward- looking statements
which speak only as of the date the statements were made.
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(1) Immunity, Feb 2011 Bomsel et al.
(2) PLOSONE Feb 2013, Leroux-Roels et al.
Contact Information
Contacts:
Mymetics Corporation
Ronald Kempers
CEO
Tel: +41 21 653 4535
Texas Biomedical Research Institute
Lisa Cruz
Director of Public Relations
San Antonio, TX, USA
Work: 210-258-9437 / Cell: 210-724-1691
Email: lcruz(at)txbiomed.org
Media:
Christophe Lamps
Senior Partner
Dynamics Group
Mobile: + 41 79 476 26 87
Email: cla(at)dynamicsgroup.ch
USA:
Michelle Linn
Phone: +1 774 696 38 03
linnmich(at)comcast.net
This announcement is distributed by GlobeNewswire on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Mymetics Corporation and Texas Biomedical Research Institute via GlobeNewswire
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