Press release N 17/2019 of 30 September 2019

MOLOGEN AG: Update on development status of lead product candidates

- Presentation of the results of the IMPALA study including discussion as part of a "Proffered Paper Session" at ESMO 2019

- Important data published that supports future combination strategy

- Development of the follow-up candidate EnanDIM^(R) on track

- Progress in the area of HIV

Berlin, 30 September 2019 - Today, the biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900 / WKN A2LQ90) published the results of its Phase III IMPALA study at the ESMO 2019 conference (EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY) in Barcelona. Prof. Ramon Salazar, Barcelona, a recognized opinion leader and member of the scientific Steering Committee for the IMPALA study, presented the data. As part of a Proffered Paper Session, an expert was invited to discuss the data and put them into perspective. In light of the IMPALA top-line data, the Company has redirected its future strategic focus on combination approaches both for lefitolimod and the first clinical candidates from the EnanDIM^(R) family across all current and planned studies.

Important new data to support the combination strategy for lefitolimod was published by the renowned scientific journal Oncolmmunology. This data is also educating the development of the first clinical candidates of the EnanDIM^(R) platform, which is scheduled to enter clinical development at the start of 2020.

IMPALA data presentation at ESMO

The presentation given by Prof. Ramon Salazar, Barcelona, Head of Medical Oncology at Duran i Reynals Hospital and Director of Corporate Research at the Catalan Institute of Oncology, Barcelona, Spain and Member of the IMPALA Steering Committee, as well as the follow-up discussion of the IMPALA data was received with considerable interest among scientific experts. Although the study did not show the expected superiority of lefitolimod as a single-agent therapeutic in comparison with standard therapy, the confirmation of the favorable safety and tolerability profile and of the once again proven activation of the immune system provide strong support for the strategic decision to focus future development work exclusively on combination approaches with lefitolimod and EnanDIM^(R).

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New data to support combination strategy; EnanDIM^(R) development on track

Important new data to support the combination strategy for lefitolimod with other immunotherapies were published by the renowned scientific journal Oncolmmunology. In these preclinical trials, a beneficial modulation of the tumor microenvironment (TME) was shown. The activation of sustained anti-tumor immunity and synergistic potentiation of the efficacy of checkpoint inhibitors could also be demonstrated. This data is also informing the clinical development strategy for the first candidate from the EnanDIM^(R) family, which is planned to enter clinical testing at the start of 2020.

Details on the publication:

The article entitled "" has been published at:

Additional information on Oncolmmunology can be found at:


Progress in the area of HIV

In addition to the ongoing established collaboration with the research team of the Aarhus University Hospital in Denmark within the framework of the (), evaluating the TLR9 agonist lefitolimod in combination with innovative, virus-neutralizing antibodies from the research laboratories of the Rockefeller University in New York, USA, an additional collaboration has now been agreed with a leading HIV expert, Prof. Dan Barouch (Center for Virology and Vaccine Research, Harvard Medical School, Boston, USA), whose research program will put several candidates from the EnanDIM^(R) family to test.

MOLOGEN AG

MOLOGEN AG is a German biopharmaceutical Company and a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapies for the treatment of HIV.

The focus of MOLOGEN's development is on DNA-based TLR9 agonists. This includes the lead compound, the immunotherapy lefitolimod, and its next generation molecules EnanDIM^(R), building the foundation for a next generation immunotherapy platform in areas of unmet need.

Forthcoming milestones include: the start of the TITAN study in HIV, the start of the clinical development of EnanDIM^(R) and additional combination studies in cancer, including one with our strategic partner Oncologie Inc., which are in an advanced planning stage.

MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares (ISIN, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.

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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.