New Tuberculosis Vaccine Reaches Further Clinical Development Milestone

17-Jul-2015 - Germany

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.’

https://www.bionity.com/en/news/153694/new-tuberculosis-vaccine-reaches-further-clinical-development-milestone.html