DGAP-News: MOLOGEN AG

PRESS RELEASE N 18 / 2017 of 11/01/2017

MOLOGEN AG: Grant of US$ 2.6 million for further development of vaccine

Berlin, 1 November 2017 - The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) was granted subsidies from the Global Health Innovative Technology (GHIT) Fund amounting to US$ 2.6 million. This amount is part of a grant from the GHIT Fund totaling US$ 3.6 million to be received by an international consortium to which MOLOGEN belongs, to further develop a leishmaniasis vaccine candidate. The underlying platform technology, MIDGE^(R) vector system, has been developed by MOLOGEN inter alia for vaccines against infectious diseases. In the first instance MOLOGEN will provide the vaccine transitionally for the studies to be carried out within the project and at the same time support activities to transfer the vaccine production to a contract manufacturer. MOLOGEN does not intend to continue the studies itself. MOLOGEN is currently preparing the divestment of the MIDGE^(R) technology within the framework of the Next Level strategy. The GHIT funding provides a firmer basis for the further and timely development of the project through a partner, and it also further validates the platform technology.

The project is coordinated by the European Vaccine Initiative, a leading European "Product Development Partnership" organization for the development of vaccines against infectious diseases with high medical need. Besides the Nagasaki University, Japan, also the London School of Hygiene and Tropical Medicine, Great Britain and the Charité - Universitätsmedizin Berlin, Germany, belong to the consortium as long-term scientific partners of MOLOGEN. The grant of the GHIT Fund enables the consortium to conduct additional preclinical studies and to prepare a clinical phase I study to test the safety and immunogenicity of the leishmaniasis vaccine in humans. With regard to pharmaceutical research and development, leishmaniasis is a neglected disease. A large proportion of the world's population is affected by this disease, especially in the poorer regions of the world.
"The commitment of the GHIT grant is an important step for the further validation of the MIDGE^(R)- technology - with this, the consortium is able to significantly contribute to the development of a leishmaniasis vaccine and to a treatment. Furthermore, the application of the MIDGE^(R)-molecules for this important vaccine corroborates the value of this platform technology, and also supports the process of the planned divestment of the technology", says Dr Mariola Soehngen, CEO of MOLOGEN.

Within the framework of the realignment and the Next Level strategy in summer 2016, MOLOGEN had decided to sell or spin-off the MIDGE^(R) technology. Consequently, the participation of MOLOGEN in this project is subject to the condition that a partner will take its place short-term. Therefore, intensive discussions are currently being conducted in this regard. With the help of this grant, the future partner will be able to extend the data base for the technology platform MIDGE^(R). Therewith, the project is contributing to a further validation of this technology. Thus, a significantly strengthened MIDGE^(R)-portfolio can be offered to future licensees of the technology or to a new spin-off company.

Global Health Innovative Technology (GHIT)
The GHIT Fund is the world's first public-private partnership (PPP) in which a consortium of private companies have come together to work with government and the civil sector to facilitate and fund global health technology discovery and development through global partnerships. As for partners, members of the GHIT Council include representatives from the Japanese Government, the pharmaceutical industry, the Bill & Melinda Gates Foundation, and the Wellcome Trust.

The GHIT Fund aims to facilitate the global R&D partnerships for the discovery and development of new healthcare technologies for the developing world. To this end, the GHIT Fund invests in global R&D partnerships through a grant-making mechanism, thereby facilitating international partnerships that bring Japanese innovation, investment, and leadership to the global fight against infectious diseases and poverty in the developing world.

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 approximately 350 million people worldwide are at risk of contracting leishmaniasis. Recent epidemiological evaluations by WHO resulted in an estimate of around one million cases and up to 30,000 deaths caused by visceral leishmaniasis annually. Among parasitic diseases, this rate is surpassed only by malaria.

MOLOGEN AG
MOLOGEN AG is a biopharmaceutical company and considered a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-oncology, MOLOGEN AG develops immunotherapies for the treatment of infectious diseases.
The immunotherapy lefitolimod (MGN1703) is the company's lead product and is regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. In contrast to other TLR9 approaches lefitolimod is exclusively composed of natural DNA and may therefore be less prone to non-specific side effects and exhibits a broad therapeutic window, which allows for both, systemic treatment (i.e. subcutaneous injection) and intra-tumoral administration. On account of this mode of action, lefitolimod (MGN1703) is an immune surveillance reactivator (ISR) and could potentially be used in various indications. The ISR lefitolimod (MGN1703) is currently being developed within the framework of a pivotal study for first-line maintenance therapy for colorectal cancer. The phase II IMPULSE study in small cell lung cancer is showing positive results in two previously defined and clinically relevant patient sub-groups, even though the primary endpoint "Overall Survival" in the overall study population was not met in this very challenging indication. Detailed analyses of IMPULSE data and the recently published TEACH data of the extension phase are currently being conducted. In addition, lefitolimod (MGN1703) is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy^(R)) in various cancer indications. Alongside with various checkpoint inhibitors, lefitolimod, which is being investigated as part of a phase III clinical trial currently, is one of the few near-to-market product candidates in the field of immuno-oncology.

MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a great medical demand in particular.

www.mologen.com
Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com

Disclaimer
Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.