DGAP-News: MOLOGEN AG: Publication of important results from the TEACH study in HIV patients

PRESS RELEASE N 12 / 2019 of 07/22/2019

MOLOGEN AG: Publication of important results from the TEACH study in HIV patients

Berlin, 22 July 2019 - The biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900, SIN A2L Q90) reports today that the renowned scientific journal EBioMedicine (Journal of The Lancet group) published a comprehensive article on the exploratory phase Ib/IIa TEACH trial using the company's lead compound, lefitolimod, in the HIV indication. The study, conducted in cooperation with the Aarhus University Denmark and which concluded in 2018, showed important positive effects of lefitolimod on the activation of anti-viral immunity in HIV patients treated with anti-retroviral therapy (ART). The publication presents further important findings regarding the ability of lefitolimod to modulate the immune response in the lymph nodes of HIV patients by inducing the differentiation of B cells and promoting a marked interferon response. This modulation of anti-viral immunity in the lymph nodes by lefitolimod is especially important given that this is where HIV persists, and thus evades antiretroviral therapy. These data, combined with the favorable safety profile of lefitolimod which was again confirmed, are another important stepping stone in the development strategy for lefitolimod in HIV.

Lefitolimod is an immune-therapeutic drug candidate, consisting of entirely natural DNA, which is in late-stage clinical development, currently being investigated in the pivotal phase III IMPALA study in the metastatic colorectal cancer indication, of which top-line results are expected in August 2019, as well as in a phase IIa combination study with the Yervoy^(R) (Ipilimumab) in various solid tumors.

In HIV, the phase IIa TITAN study, which is financed by pharmaceutical drug company Gilead Sciences Inc., Foster City, USA, is expected to start recruiting in summer 2019. Moreover, plans for another combination study with a renowned U.S. center are at an advanced stage.

MOLOGEN's product pipeline also includes the next generation platform EnanDIM^(R). The preclinical development of a first candidate from that family of TLR9 agonists progressed as planned and the start of the clinical phase is expected for the end of 2019.

The full publication in EBioMedicine is available at: https://doi.org/10.1016/j.ebiom.2019.07.005

MOLOGEN AG
MOLOGEN AG is a 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 infectious diseases.

The focus of the development work is on the product family of DNA-based TLR9 agonists. This includes the lead compound lefitolimod and the next-generation molecule family EnanDIM(R).

The immunotherapeutic agent lefitolimod is the Company's lead compound and is currently being investigated in a pivotal trial. It is regarded as the best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. On account of this mode of action, lefitolimod could potentially be used in various indications. Lefitolimod is currently being developed within the framework of a pivotal study for first line maintenance therapy for colorectal cancer. Key data of the phase II IMPULSE study in extensive-stage small cell lung cancer (ES-SCLC) and the data from the extension phase of the TEACH study in HIV have been published.
In addition, lefitolimod is currently being investigated in a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)) in various cancer indications. Along 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.

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.

www.mologen.com

Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 37
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.