annual report 2008 - Pevion Biotech AG

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2008 ANNUAL REPORT 10 M A L A R I A V A C C I N E ( P A R T N E R E D W I T H M Y M E T I C S ) Pevion Biotech’s approach The malaria parasite Plasmodium falciparum has a complex life cycle involving three stages in the human body. Pevion Biotech is therefore focusing on a multicomponent (multivalent) malaria vaccine: Each component targets another antigen specific to a defined development stage. Pevion Biotech uses its well-established virosome technology platform for the delivery of the newly developed peptide antigens into the human body. In subsequent steps the company has developed the vaccine formulations to clinical development. In 2007, clinical Phase IIa with the twocomponent malaria vaccine candidate was completed. New in 2008: Clinical Phase Ib started with the two-component malaria vaccine candidate in the malaria field in Bagamoyo, Tanzania. The final clinical Ib study report will be completed in 2009. Need of a malaria vaccine Malaria remains one of the world’s greatest public health challenges. It is one of the biggest killers among communicable diseases today. An estimated 40% of the world’s population is at risk of malaria with 500 million cases annually, resulting in 1-2 million deaths each year, mostly young children and pregnant women in sub-Saharan Africa. The emergence of widespread resistance to anti-malaria drugs such as chloroquine and the difficulty of controlling the mosquito vector have hampered the control of the disease. As yet no vaccine is available. C A N D I D A V A C C I N E I N P R E C L I N I C A L D E V E L O P M E NT Pevion Biotech’s approach Pevion Biotech's candidiasis vaccine is a first-in-class product for the prevention and treatment of Candida albicans infections. The monovalent vaccine is specifically designed to prevent/treat recurrent or chronic vulvovaginal candidiasis. This indication was not accessible for conventional vaccines, whereas Pevion Biotech's proprietary technology allows the specific assessment of the pathogens infecting the human mucosa. The vaccine targets a high unmet medical need since chronic vulvovaginal candidiasis is currently treated with drugs having quite adverse effects und a limited longterm efficacy. Pevion Biotech's Candida vaccine is based on the rSap2 antigen, a recombinant truncated form of the native Sap2, coupled to the surface of virosomes. New in 2008: Pevion has licensed an antigen (SAP2) from the Istituto Superiore di Sanità (ISS) for production and further clinical development of its Candida vaccine. Furthermore, Pevion Biotech approached Lonza AG to develop a scalable process for the production of the recombinant Sap2 protein. This process was successfully developed in 2008 and a cGMP production campaign is ready to be started. The molecule will be used to manufacture the monovalent anti-fungal vaccine, and Pevion Biotech plans a Phase I clinical trial to test the safety and immunogenicity of the vaccine in women. Pevion_Biotech_annual_report_2008_final.docx
2008 ANNUAL REPORT 11 Need for a Candida vaccine Nearly 70%-75% of premenopausal women experience an attack of Candida vulvovaginitis. Half of these women have more than one episode of the infection during their childbearing years and about 5% of women with a primary episode have chronic vulvovaginal Candida infections with at least 3- 4 episodes per year. OTC products (over the counter) are available for treatment of fungal infections. But the continuing increase in the incidence of infections together with the antifungal drug resistance show that there is a need of new antifungal treatment with a greater potential to prevent vulvovaginal or oral infections, especially chronic and/or recurrent infections, which pose serious problems for the overall health of the patients. R S V V A C C I N E I N P R E C L I N I C A L D E V E L O P M E N T Pevion Biotech’s approach Pevion Biotech develops its prophylactic RSV vaccine based on the RSV-Fprotein and its proprietary virosome technology platform. Due to the high incidence of RSV infections and the lack of treatment alternatives for elderly people, Pevion Biotech has identified a fundamental goal in the development of a vaccine for this target group. In vaccine development, safety issues are always of great importance and even more for weak target groups such as infants, immunosuppressed individuals or the elderly. So far, antibodies against the G and F proteins of RSV have been shown to be effective in neutralization of the virus. The G protein is largely responsible for the antigenic diversity between RSV subgroups. Therefore, Pevion Biotech is focusing on the development of a vaccine using the F protein. New in 2008: In 2008 preclinical tests were ongoing. Immunization of mice with virosomes carrying the recombinant RSV F displayed on the surface induced antibodies that were able to inhibit the viral infection in vitro and in vivo. Several other experiments indicate that this prototype of RSV vaccine is able to extend a good specific humoral and systemic immunity. Need of a RSV vaccine Although respiratory syncytial virus (RSV) is traditionally regarded as a pediatric illness, it also causes pulmonary disease in the elderly, particularly those with underlying heart and lung disease, and in immune-compromised bone marrow recipients. Even though there is a tremendous need, no vaccine is yet available. RSV vaccine development is hampered by a number of obstacles, especially the risk of inducing enhanced illness. I N F L U E N Z A V A C C I N E Pevion Biotech’s approach Pevion Biotech is developing a broad-spectrum influenza vaccine based on an optimized synthetic M2e peptide combined with the virosome platform. A broad-spectrum influenza vaccine has significant advantages over the current products, because it can provide reliable protection against all circulating virus strains, independent of epidemiological forecasts. The intervals for redevelopment of the vaccine and immunization could be extended. A broadspectrum influenza vaccine even has potential as a precaution against a novel influenza pandemic. With all these advantages, such a novel product is likely to find higher acceptance than the current vaccine, and to increase the poor vaccination rate of 20% in the overall population. Pevion_Biotech_annual_report_2008_final.docx
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annual report 2008 - Pevion Biotech AG

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