15 July 2015, Munich – Ascenion’s portfolio company Vakzine Projekt Management GmbH (VPM) and its license partner Serum Institute of India (SII) have begun a Phase II study with their new tuberculosis vaccine, VPM1002. According to the World Health Organization, tuberculosis is still among the infectious diseases with the highest mortality worldwide. In 2013 alone, around 9 million people became infected and 1.5 million died of the disease, 360,000 of whom were also HIV positive.
The new vaccine is being developed in a wide-ranging clinical programme. Two Phase I trials in adults and a Phase II trial in newborn infants have already been successfully completed. The data consistently show that VPM1002 is clearly safer and more effective than the conventional BCG vaccine that has been in use for nearly 100 years. Although it can protect against certain forms of tuberculosis, its protective efficacy is insufficient and alarmingly, BCG-related adverse events in HIV- positive newborns frequently occur. BCG also poses a high risk for any infant born with congenital genetic immunodeficiency.
The trial that has just begun is the first to be conducted in babies born to mothers with HIV. In Soweto and Cape Town, where the study is being conducted, this applies to 30–40% of births. Studies have shown that these babies’ immune systems are often affected, even if they are not themselves infected with HIV. ‘These newborns need the new, safer vaccine particularly urgently,’ says Adar C. Poonawalla, CEO and Executive Director of the Serum Institute of India.
The randomized, double-blind, controlled trial is being conducted at study centres at the Stellenbosch University, the Desmond Tutu Tuberculosis Centre, the South African Tuberculosis Vaccine Initiative and the Respiratory and Meningeal Pathogens Research Unit (ClinicalTrials.gov Identifier NCT02391415).
VPM1002, a genetically modified version of the classical BCG vaccine strain, originates from the Max Planck Institute for Infection Biology, whose founding Director, Prof. Stefan H.E. Kaufmann, was mainly responsible for the scientific concept underlying the development of the vaccine. Further scientific development was conducted together with VPM, a spin-off from the Helmholtz Centre for Infection Research (HZI). In 2013, the SII, one of the biggest vaccine developers worldwide, joined the project as global licensee. Ascenion played a key role in closing this licence agreement.
‘This is a perfect example of how an innovation originating in basic research can, step by step, be brought to application in a professional manner,’ comments Dr Christian Stein, CEO of Ascenion. ‘The launch of this study is an important milestone on the road to our joint goal: to provide the vaccine for people in all socioeconomic groups all over the world at a fair price.’
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Contact
For Ascenion:
Dr Susanne Letzelter
T: +49 89 318814-16
E: letzelter(at)ascenion(dot)de
For VPM:
Dr Bernd Eisele, CEO
T.: +49 511 169908-13
E.: eisele(at)vakzine-manager(dot)de
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About Ascenion
Ascenion GmbH is an IP asset management company with particular expertise in the life sciences. Ascenion advises and supports public research institutions with regard to the protection and exploitation of their intellectual property (patents, know-how, materials), and initiates and mediates agreements between research institutions and industry. The company places particular emphasis on coaching company founders and on active equity management. Ascenion was founded in 2001 as a 100% subsidiary of the LifeScience Foundation for the Promotion of Science and Research and is exclusive technology transfer partner of 23 research institutes in the Helmholtz and Leibniz Associations, as well as of the Charité, the Hannover Medical School and the research institute TWINCORE. Ascenion currently markets around 750 technologies on behalf of these institutes, and closes an average of about 80 revenue-generating agreements between research and industry per year. The team has also coached numerous spin-offs through their foundation and early growth and Ascenion holds equity in 26 of these companies. Ascenion’s headquarters are in Munich, with further offices in Berlin, Braunschweig, Hamburg, Hanover and Neuherberg. Further information at www.ascenion.de
About Vakzine Projekt Management GmbH (VPM)
VPM is a public–private partnership venture based in Hannover, Germany, and was founded in 2002 jointly by the German Federal Ministry for Education and Research and the Braunschweig-based Helmholtz Centre for Infection Research
. Drawing on its professional project management expertise and long-standing drug design experience, VPM is able to support researchers and show that their innovations have the potential to move out of the research labs and into clinical application, to ultimately benefit humankind.
Further information at www.vakzine-manager.de
About Serum Institute of India Ltd. (SIIL)
SIIL was founded in 1966 with the goal of creating life-saving drugs for people from all walks of life. The Institute’s special focus has traditionally been on those countries where drugs were either altogether unavailable or unaffordable for most people. At this point, the SIIL has become the world’s largest manufacturer of vaccines against measles and against diphtheria, pertussis/whooping cough and tetanus (DPT). The company has continued to increase its philanthropic focus and now also manufactures vaccines against hepatitis B, rabies, and meningitis. These efforts ensure that from the day they are born, all children – not only in India, but in more than 140 different countries all over the world – have access to life-saving medicines.
Further information at www.seruminstitute.com
The new vaccine is being developed in a wide-ranging clinical programme. Two Phase I trials in adults and a Phase II trial in newborn infants have already been successfully completed. The data consistently show that VPM1002 is clearly safer and more effective than the conventional BCG vaccine that has been in use for nearly 100 years. Although it can protect against certain forms of tuberculosis, its protective efficacy is insufficient and alarmingly, BCG-related adverse events in HIV- positive newborns frequently occur. BCG also poses a high risk for any infant born with congenital genetic immunodeficiency.
The trial that has just begun is the first to be conducted in babies born to mothers with HIV. In Soweto and Cape Town, where the study is being conducted, this applies to 30–40% of births. Studies have shown that these babies’ immune systems are often affected, even if they are not themselves infected with HIV. ‘These newborns need the new, safer vaccine particularly urgently,’ says Adar C. Poonawalla, CEO and Executive Director of the Serum Institute of India.
The randomized, double-blind, controlled trial is being conducted at study centres at the Stellenbosch University, the Desmond Tutu Tuberculosis Centre, the South African Tuberculosis Vaccine Initiative and the Respiratory and Meningeal Pathogens Research Unit (ClinicalTrials.gov Identifier NCT02391415).
VPM1002, a genetically modified version of the classical BCG vaccine strain, originates from the Max Planck Institute for Infection Biology, whose founding Director, Prof. Stefan H.E. Kaufmann, was mainly responsible for the scientific concept underlying the development of the vaccine. Further scientific development was conducted together with VPM, a spin-off from the Helmholtz Centre for Infection Research (HZI). In 2013, the SII, one of the biggest vaccine developers worldwide, joined the project as global licensee. Ascenion played a key role in closing this licence agreement.
‘This is a perfect example of how an innovation originating in basic research can, step by step, be brought to application in a professional manner,’ comments Dr Christian Stein, CEO of Ascenion. ‘The launch of this study is an important milestone on the road to our joint goal: to provide the vaccine for people in all socioeconomic groups all over the world at a fair price.’
###
Contact
For Ascenion:
Dr Susanne Letzelter
T: +49 89 318814-16
E: letzelter(at)ascenion(dot)de
For VPM:
Dr Bernd Eisele, CEO
T.: +49 511 169908-13
E.: eisele(at)vakzine-manager(dot)de
###
About Ascenion
Ascenion GmbH is an IP asset management company with particular expertise in the life sciences. Ascenion advises and supports public research institutions with regard to the protection and exploitation of their intellectual property (patents, know-how, materials), and initiates and mediates agreements between research institutions and industry. The company places particular emphasis on coaching company founders and on active equity management. Ascenion was founded in 2001 as a 100% subsidiary of the LifeScience Foundation for the Promotion of Science and Research and is exclusive technology transfer partner of 23 research institutes in the Helmholtz and Leibniz Associations, as well as of the Charité, the Hannover Medical School and the research institute TWINCORE. Ascenion currently markets around 750 technologies on behalf of these institutes, and closes an average of about 80 revenue-generating agreements between research and industry per year. The team has also coached numerous spin-offs through their foundation and early growth and Ascenion holds equity in 26 of these companies. Ascenion’s headquarters are in Munich, with further offices in Berlin, Braunschweig, Hamburg, Hanover and Neuherberg. Further information at www.ascenion.de
About Vakzine Projekt Management GmbH (VPM)
VPM is a public–private partnership venture based in Hannover, Germany, and was founded in 2002 jointly by the German Federal Ministry for Education and Research and the Braunschweig-based Helmholtz Centre for Infection Research
. Drawing on its professional project management expertise and long-standing drug design experience, VPM is able to support researchers and show that their innovations have the potential to move out of the research labs and into clinical application, to ultimately benefit humankind.
Further information at www.vakzine-manager.de
About Serum Institute of India Ltd. (SIIL)
SIIL was founded in 1966 with the goal of creating life-saving drugs for people from all walks of life. The Institute’s special focus has traditionally been on those countries where drugs were either altogether unavailable or unaffordable for most people. At this point, the SIIL has become the world’s largest manufacturer of vaccines against measles and against diphtheria, pertussis/whooping cough and tetanus (DPT). The company has continued to increase its philanthropic focus and now also manufactures vaccines against hepatitis B, rabies, and meningitis. These efforts ensure that from the day they are born, all children – not only in India, but in more than 140 different countries all over the world – have access to life-saving medicines.
Further information at www.seruminstitute.com
