MOLOGEN AG: Consortium successfully concludes preclinical development of DNA vaccine against leishmaniasis

MOLOGEN AG: Consortium successfully concludes preclinical development of DNA vaccine against leishmaniasis

- Expert panel confirms positive results

- Planning for phase I clinical studies begins

The LEISHDNAVAX consortium*, with MOLOGEN AG as a key partner has successfully concluded the preclinical development of a MIDGE(R)-based vaccine against leishmaniasis (MGN1331). Within the framework of the project, the new human vaccine has been examined as to its efficacy and safety in animal models, for prophylactic as well as therapeutic applications. MGN1331 showed outstanding results.

The independent panel of experts that reviewed the results within the framework of a final project symposium confirmed the very promising results.

Reviewer Prof. Dr. N.K. Ganguly, former director of the Indian Council of Medical Research and expert in immunology of tropical diseases, said in this regard: 'The preclinical data presented by the consortium are decidedly promising. In particular, the applicability to the prevention of this dangerous disease means immense progress in the fight against leishmaniasis.'

Prof. Simon Croft, project coordinator and Faculty Head at the London School of Hygiene and Tropical Medicine, adds: 'Our joint objective to develop an effective prevention vaccine for leishmaniasis that could also be used therapeutically highly motivated all the consortium partners.
It is most gratifying for all the participants that the promising results more than justify the hard work of the past three years.'

As one step of the preclinical development, first scientific meetings with the European Medicines Agency (EMA) and the Paul-Ehrlich Institute have taken place already, so that the planning of phase I clinical studies can begin now. Possibilities for further subsidies are currently explored.

MOLOGEN AG: 'Within the framework of this project, our MIDGE(R) technology showed, in an impressive way, what a powerful effect it has on a disease as difficult to prevent and to treat as leishmaniasis. I thank all the partners of the consortium for the good and so successful collaboration,' remarks Dr. Matthias Schroff, Chief Executive Officer of MOLOGEN AG.
He adds, 'We now have another product candidate that is ready to enter the clinical study phase. The product pipeline of MOLOGEN AG has made further great progress in the first half of the year: outstanding clinical data from the colorectal cancer study with MGN1703 and from the renal cancer study with MGN1601. And now the successful conclusion of the preclinical work on our leishmaniasis vaccine, MGN1331.'

The project was supported by the European Union to the amount of EUR 3 million as part of the Seventh Framework Program.

About leishmaniasis

Leishmaniasis is a cluster of diseases caused by different species of Leishmania parasites with diverse clinical manifestations, most of them difficult to treat or even fatal if untreated.

On five continents, leishmaniasis occurs in tropical and subtropical regions and has been classified by the WHO as a very important neglected tropical disease. According to WHO (2010), approximately 350 million people are at risk of contracting leishmaniasis with an estimated number of two million new cases per year. Recent epidemiological evaluations by WHO resulted in an estimate of about 40,000 deaths caused by visceral leishmaniasis annually. Among parasitic diseases, this rate is surpassed only by malaria. Moreover, each year approximately 1.2 million people develop cutaneous leishmaniasis.

About MGN1331

The DNA vaccine MGN1331 consists of a combination of MIDGE(R) vectors encoding different Leishmania antigens. In animal models, promising efficacy and a very good safety profile of MGN1331 has been shown.

In the field of biotechnology, transport vehicles for conveying nucleic acids (mostly DNA) are called vectors. The MIDGE(R) technology developed by MOLOGEN (MIDGE(R) stands for Minimalistic Immunologically Defined Gene Expression) is also termed a DNA vector. However, unlike other DNA vectors (plasmids, viruses), the MIDGE(R) vector contains only the information necessary for the actual effect. Its minimalistic design ensures avoidance of undesirable components often found in conventional vectors.

MIDGE(R) vectors form the basis for a broad spectrum of modern, DNA-based applications. These vectors are designed with various characteristics that are partly individualized and are exceptionally well suited for both gene therapy for cancer and DNA-based vaccination against infectious diseases.

* The consortium:

- London School of Hygiene & Tropical Medicine (LSHTM)

- Charité - Universitätsmedizin Berlin (Charite)

- Indian Institute of Chemical Biology (IICB), Kolkata

- Institut Pasteur de Tunis (IPT)

- Hebrew University of Jerusalem (HUJI)

- Rajendra Memorial Research Institute of Medical Sciences (RMRI-MS)

- Drugs for Neglected Diseases Initiative (DNDi)

- MOLOGEN AG