Copenhagen, September 5, 2014
NeoStrep, a consortium consisting of Lund University (Sweden), MinervaX ApS (Denmark), CiToxLAB A/S (Denmark), and BioKinetic Europe Ltd. (UK), announced today to have completed the identification of the optimal adjuvant formulation, dose and dosing regimen of a novel vaccine against Group B Streptococcal (GBS) infections. These results mark the achievement of the first specific objective of the non-clinical phase of the NeoStrep project.
The research performed by the NeoStrep Consortium to select the adjuvant formulation, the route of administration and the dosing regimen of the vaccine candidate has been illustrated in a study report submitted last July 31 to the European Commission (EC). The EC is co-funding the NeoStrep project trough the 7th Framework Programme for Research and Technological Development.
In addition to these important results, earlier in June the Neostrep consortium had also obtained official recommendations from the Swedish Health Regulatory Authority on the required pre-clinical package (safety and toxicology) necessary to support clinical use of GBS-NN.
GBS infections are responsible for 50% of life-threatening infections in newborns. The aim of the NeoStrep consortium is to provide a safe and effective alternative to current generally implemented antibiotic prophylaxis. The goal of the project is to built on extensive positive results obtained in animal models for developing a novel innovative GBS vaccine candidate, with much improved immunogenicity, coverage of clinical isolates (95% compared to only 60-70% for other candidates) and ease of manufacturing over state-of-the-art GBS vaccine candidates.
The NeoStrep consortium is now going to advance the vaccine candidate through cGMP manufacturing and toxicology studies. Proof-of-concept testing in human clinical trials is due to start in 2015.
Copenhagen, January 8, 2014
NeoStrep, a consortium consisting of Lund University (Sweden), MinervaX ApS (Denmark), CiToxLAB A/S (Denmark), and BioKinetic Europe Ltd. (UK), announced today that it has been awarded EUR 6 million in funding under the European Commission FP7 Programme HEALTH, for the development of a novel innovative Group B Streptococcal Vaccine candidate, owned by MinervaX.The consortium is coordinated by Lund University and MinervaX is responsible for project management. Together with co-funding provided by the individual partners, the funding will allow for the advancement of the GBS vaccine candidate to clinical proof of concept in Phase IIa by late 2016.
Despite the introduction of extensive use of antibiotic prophylaxis, GBS is responsible for up to 50% of life-threatening bacterial infections in newborn infants and carries a significant risk of either long-term disability or death. Approximately 15-25 % of women are colonized with GBS in their vaginal flora, from which GBS may spread to the child before or during childbirth. Newborn infants are also at increased risk of contracting GBS infections up to 3 months after birth. Infection of the unborn child may lead to premature labour or stillbirth, and infection of the newborn infant may result in severe infections such as pneumonia, septicaemia and meningitis, which all carry a high risk of long-term disability or death. In addition to newborns, GBS infections are also a growing concern in the elderly.
The extensive use of GBS antibiotic prophylaxis in birthing women has resulted in the emergence of antibiotic resistance. The development of wide spread antibiotic resistance in GBS will significantly impair the effectiveness of current preventive strategies, as well as the effectiveness of treatment options in the remaining GBS infections. The development of a GBS vaccine will prevent GBS infections without the need for antibiotic prophylaxis and hence reduce the risk of widespread antibiotic resistance developing in GBS. A GBS vaccine therefore addresses a major medical need, and will help protect pregnant women, newborn infants and the elderly against stillbirths, severe disease, long-term disability or death.
The NeoStrep vaccine candidate employs a novel innovative protein-only strategy, and is based on a fusion protein (GBS-NN) containing the N-terminal domains of the Rib and Alpha surface glycoproteins of GBS. The vaccine candidate has been shown to elicit a highly protective immune response in animal models of GBS infection, and is capable of neutralizing the clinically most relevant strains of GBS responsible for up to 95% of all infections (Serotypes Ia, Ib, II, III, & V) all in a single vaccine component.
The vaccine candidate is currently undergoing GMP manufacturing in preparation for clinical trials to be initiated early 2015