UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 13, 2010
Mymetics Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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000-25132
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25-1741849
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(State of other jurisdiction
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(Commission
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(IRS Employer
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of incorporation)
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File Number)
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Identification No.)
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Route de la Corniche 4
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1066 Epalinges, Switzerland
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NA
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code: +011 41 21 653 45 35
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item 8.01. Other Events.
On September 13, 2010, the registrant (Mymetics) issued a press release regarding the
partial funding by the National Institutes of Health (NIH) of a new preclinical trial at the
University of California, Davis. The study will be led by Professor Christopher J. Miller of the
California National Primate Research Center to test the effectiveness of a candidate HIV vaccine in
a nonhuman primate model. A copy of the press release is furnished as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d)
Exhibits.
99.1 Press Release dated September 13, 2010
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Date: September 13, 2010
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MYMETICS CORPORATION
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By:
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/s/ Jacques-François Martin
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Jacques-François Martin
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President and Chief Executive Officer
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Exhibit 99.1
Press Release: dated September 13 2010
Mymetics novel HIV vaccine to begin new NIH-funded study
at University of California, Davis
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Prof. Christopher J. Miller to lead proof-of-concept study on innovative HIV vaccine
aimed at preventing mucosal transmission and infection in macaque monkeys
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Preclinical trial follows previous study where vaccine provided unprecedented 100% protection
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Epalinges,
Switzerland, 13 September 2010
Mymetics Corporation (OTCBB: MYMX), a pioneer in the
development of vaccines preventing mucosal transmission of human infectious diseases, announced
today that its innovative HIV vaccine will enter a new preclinical trial at the University of
California, Davis. The study will be led by Professor Christopher J. Miller of the California
National Primate Research Center, a leader in immunodeficiency virus transmission in nonhuman
primate models, and partially funded by the NIH (National Institutes of Health). It follows a
recently completed smaller study at the Institute of Laboratory Animal Science (ILAS) in Beijing,
China in which the vaccine provided an unprecedented 100% protection in macaque monkeys. The
vaccine is also currently in a Phase I trial in human volunteers.
Professor Christopher J. Miller said, Mymetics
HIV vaccine is the first with a demonstrated ability to prevent viral transmission in
primates. We are happy that the NIH has decided to partially fund this study and we hope to confirm
the previous findings and learn more about this vaccines mechanism of action in providing mucosal protection.
Jacques-François
Martin, CEO of Mymetics, commented, Almost all other HIV vaccines under investigation
target late infection events, once the virus has already invaded the body. Our recent results,
showing that protection by mucosal antibodies might play a key role, have elicited strong interest
among key opinion leaders, challenging the current dogma that blood antibodies will provide the
main protection against mucosally transmitted pathogens like HIV.
He added: We are very pleased about our collaboration with Chris
Miller, a leading expert in this
field and are grateful to the NIH for supporting this new study. This funding represents a
milestone and an important recognition of the work performed by Mymetics over the last years, and
in particular by Sylvain Fleury, our Chief Scientific Officer, and his team.
With its HIV-1 (Human Immunodeficiency Virus type 1) vaccine, 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. By minimizing homology between the vaccine and native human
proteins, Mymetics further aims to avoid potential auto-immune complications resulting from
cross-reactivity. The new trial, to begin in October 2010, will involve 48 macaque monkeys of a
commonly used strain (n=12 per group) and compare three antigen vaccination regimens with placebo,
followed by heterologous intra-vaginal challenges with live virus. Results, which will include
several new immunological parameters, are expected at the end of Q4 2011.
Recent results obtained from a smaller scale macaque trial in China on Mymetics HIV vaccine
demonstrated 100% protection in one arm of the study against multiple intra-vaginal challenges with
heterologous live virus, while the placebo group became fully infected. These results are
unprecedented for this type of HIV vaccine study. The vaccine is also currently in a Phase I
clinical
trial in Belgium in human volunteers and has already been shown to be well tolerated, as announced
in January 2010.
About HIV and the Mymetics vaccine approach
2.7 million new people were infected by HIV in 2008 while an estimated 2 million people died of
AIDS in that year. 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 on an HIV vaccine in Thailand, reported in
September 2009, showed a modest protective effect of 31%, providing encouraging support for the
feasibility of an effective HIV vaccine.
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 protection has been seen with heterologous challenges, in which the virus strain
differs from the original vaccine. Some of the reasons for the lack of success in the past include
the selection of antigens that poorly mimic native viral proteins and folding, as well as the
ability of HIV to escape the CTL response through mutations. 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 but,
until now, poorly investigated approach to preventing HIV infection. Obstacles have included a lag
in knowledge about the mucosal immune system and its antibody response, as well as the invasiveness
of the methods required and the sensitivity of the tests needed to detect mucosal antibodies,
compared with blood. However, mucosal antibodies, mostly of the functionally distinct IgA type as
opposed to the IgG type found in the blood, are produced in high quantities and may prevent HIV
from reaching the bloodstream. 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 specifically intended to induce a mucosal antibody response against HIV while also
inducing blood antibodies.
About the NIH grant to Professor Christopher J. Miller
A supplement to the Base Grant Operating Grant of the California National Primate Research Center
(NCRR 00169) has been awarded by NIH to support a study by Dr Christopher J. Miller, to test the
effectiveness of a candidate HIV vaccine from Mymetics Corporation in a nonhuman primate model.
Christopher J. Miller, D.V.M., Ph.D. is a Professor of Pathology, Microbiology and Immunology in
the School of Veterinary Medicine and an Adjunct Professor of Medicine in the School of Medicine.
Dr Miller is a veterinarian and virologist, a core faculty member of the Center for Comparative
Medicine and a Staff Scientist at the California National Primate Research Center. His laboratory
utilizes nonhuman primate models of AIDS and influenza A virus infection to define the pathogenesis
of these viral infections, study the nature of protective antiviral immunity, and test vaccines and
immunotherapeutic strategies to prevent AIDS and influenza.
The
National Institutes of Health (NIH) The United States Medical Research Agency includes 27 Institutes
and Centers and is a component of the U. S. Department of Health and Human Services. It
is the primary federal agency for conducting and supporting basic, clinical and translational
medical research, and it investigates the causes, treatments and cures for both common and rare
diseases. For more information about NIH and its programs, visit
http://www.nih.gov
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About Mymetics
Mymetics Corporation is a Swiss-based biotechnology company registered in the US (OTC BB:
MYMX) developing next-generation preventative vaccines for infectious
diseases. Mymetics core technology and
expertise are based on the use of virosomes, lipid-based carriers containing functional fusion
viral proteins, in combination with rationally designed antigens. The
companys 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 vaccine. Mymetics is led by an international and experienced management team and is
supported by a strong Scientific Advisory Board composed of renowned experts. The company has
established contacts with world leaders in vaccine development.
Mymetics currently has 5 vaccines in its pipeline: HIV-1/AIDS, Influenza, Respiratory Syncytial
Virus, Malaria and Herpes Simplex Virus. The companys HIV
vaccine is entering a new proof-of-concept preclinical trial
following unprecedented results in a first study, and is also currently in a Phase I clinical trial
in human volunteers. A Phase 1b clinical trial for its Malaria vaccine on children in Tanzania has
been completed, while RSV and HSV vaccine candidates are in the preclinical phase. The Influenza
vaccine has been out-licensed to Solvay Pharmaceuticals (now Abbott). For further information,
please visit
www.mymetics.com
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Contact:
Ronald Kempers
CFO and COO
Mymetics Corporation
Tel: +41 21 653 4535
Media:
Christophe Lamps
Senior Partner
Dynamics Group
Mobile: + 41 79 476 26 87
Email:
cla@dynamicsgroup.ch
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.