Mymetics Corporation, a pioneer in the development of vaccines preventing mucosal transmission of human infectious diseases, announced strong preliminary results of a phase I trial on its promising HIV vaccine, MYMV101. Unlike most current vaccines, seeking to eliminate pathogens once they have already entered the bloodstream, Mymetics’ vaccines are designed to block early transmission and infection events, preventing virus from settling and spreading within the body. This represents a highly promising but, until now, poorly investigated approach to preventing HIV infection.

The phase I trial was conducted on 24 healthy women. The vaccine was well tolerated and immunogenic in both low and high dose vaccinated groups. The majority of volunteers developed not only serum antibodies but also mucosal antibodies in the genital and intestinal tracts.

“These new results represent a major achievement for Mymetics,” commented Sylvain Fleury, CSO of Mymetics. “Very few HIV vaccine candidates developed over the last 25 years could elicit both blood and mucosal antibodies as a front-line defence mechanism against the entry of HIV-1 across mucosal tissues.”

Jacques-François Martin, CEO of Mymetics, added, “Our vaccine represents a first line of defence before the virus can settle in the tissue and spread within the body. These preliminary phase I results in HIV-1/AIDS represent an important validation of our pioneering work and approach. They also confirm a previous preclinical study where the vaccine provided unprecedented 100% protection in primates.”

The phase I trial, started in December 2009, is a placebo-controlled, double-blind, single-site study, conducted by Prof. G. Leroux-Roels at the Centre for Vaccinology (CEVAC) at the University of Ghent (Belgium), under the supervision of Kinesis-Pharma, a CRO under contract with Mymetics. During the vaccination, women received high or low dose vaccinations. The first two injections were performed intra-muscularly and the last two via intra-nasal spray. The final clinical report is expected in January 2011, which will then also include the analysis of the neutralizing characteristics of the antibodies.

HIV-1, the virus that causes AIDS, is primarily transmitted through sexual contact, exposing the mucosal tissues of the genital organs as the first entry door for the virus before it reaches the blood. HIV-1 infected about 2.7 million new people in 2008, while an estimated 2 million people died of AIDS in the same year. HIV-1-related illness remains one of the leading causes of death globally and is projected to remain a significant cause of premature mortality in the coming decades.

The vast majority of pathogens enter their target hosts through mucosal surfaces such as the respiratory, genito-urinary or gastrointestinal tracts. Once they have reached the blood, pathogens can migrate to various organs where they replicate. Most current vaccines seek to eliminate pathogens once they have already entered the bloodstream, by which time control of the pathogen can be significantly more challenging (e.g. HIV-1). Classical vaccines work by inducing mostly blood antibodies (mainly IgG) and are poor at triggering the antibodies that predominate in all mucosal tissues (mainly IgA).

Mymetics has created a vaccine against HIV-1, using its virosome technology and judicious antigen design. The vaccine primarily induces mucosal antibodies, preventing HIV-1 attachment to epithelial cells and providing an efficient first line of defence on mucosal surface such as the genital tract. The vaccine also induces blood antibodies, which will ideally function as a complementary second line of defence. By minimizing homology between the vaccine and native human proteins, Mymetics further aims to avoid auto-immune complications resulting from cross-reactivity.

The Centre for Vaccinology (CEVAC) is an academic research unit affiliated with Ghent University and located in the Ghent University Hospital (Ghent, Belgium), and that provides a wide array of services to the biotech industry and vaccine manufacturers. CEVAC conducts Phase I, II and III clinical vaccine trials according to ICH-GCP standards and offers a panel of laboratory services in the field of immunology and vaccinology, such as serological tests, cytokine measurements, B and T lymphocyte detection and function assays.

Kinesis Pharma B.V. (founded 1997) is an independent, privately owned drug development consultancy and contract research organization. Kinesis operates internationally with headquarters in Breda (The Netherlands) and a regional office in Singapore. The organization leverages the expertise and experience of its highly-skilled, multi-disciplinary workforce to accelerate drug development. Kinesis Pharma facilitates fast and high quality development and registration of medicinal products with consultancy services in Chemistry, Manufacturing and Control- (CMC), non-clinical- and clinical development and regulatory support.

Kinesis operates in close collaboration with pharmaceutical, nutraceutical and biotech companies and has successfully managed the development and registration of pharmaceutical and biotechnology-derived products in different therapeutic areas, including infectious diseases.

Mymetics Corporation is a Swiss-based biotechnology company registered in the US developing next-generation preventative vaccines for infectious diseases. Mymetics core technology and expertise are centred on the use of virosomes, lipid-based carriers containing functional fusion viral proteins, in combination with rationally designed antigens.