DGAP-News: MOLOGEN AG

PRESS RELEASE N 12 / 2017 of 08/09/2017

MOLOGEN AG: Results of the extension phase of the exploratory phase Ib/IIa study in HIV

Berlin, 9 August 2017 - The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced the key results of the extension phase of the exploratory phase Ib/IIa TEACH trial to evaluate lefitolimod in HIV-positive (HIV: human immunodeficiency virus) patients on antiretroviral therapy (ART). The study, a cooperation with the Aarhus University Hospital in Denmark, was extended based on the positive results seen in the initial study phase as recently published¹. Findings from the extension phase of TEACH suggest - although lefitolimod alone on top of ART did not show the desired effect on the viral reservoir - the compound could be an important combination partner for other interventions aiming at HIV cure, such as monoclonal antibodies or vaccines.

This conclusion is supported by the main following study results:

- Sustained increases in activation of important immune cells (CD4 and CD8 T cells) were observed throughout the dosing period of 24 weeks.

- Lefitolimod triggered maturation of other important immune cells (B cells) towards antibody-producing cells.

- After interruption of ART, one of the nine patients who participated in that study part showed viral control for more than 20 weeks, whereas the interval until viral rebound is generally two weeks.

- The intervention had no detectable effects on the size of viral reservoir in peripheral blood in the total study population of 12 patients, which was defined as the primary endpoint of the extension phase of the study.

- 24 weeks of lefitolimod treatment was safe and well tolerated in HIV patients on ART, corroborating the favourable safety profile already seen in cancer patients.

"The available T and B cell data together with its excellent safety profile suggest that lefitolimod could be very well suited to be combined with other promising HIV cure interventions such as monoclonal antibodies or an HIV vaccine. Such a combination trial has recently been funded and is expected to start in 2018 as a collaboration between MOLOGEN, Aarhus University Hospital and other international partners. Furthermore, the finding that one patient controlled viral replication to below the limit of detection and remained off ART for 22 weeks is very intriguing and is currently under intensive evaluation", said Ole Schmeltz Søgaard, MD, PhD, Associate Professor at the Aarhus University Hospital and principal investigator of the study, Department of Infectious Diseases, Aarhus, Denmark.

The most common related adverse events in the extension phase of the TEACH study were neutropenia, injection site reaction, fatigue, dizziness, and headache. The majority of adverse events were of mild or moderate intensity with no life-threatening or fatal events. There were no discontinuations due to adverse events and no related serious adverse events.

Dr Matthias Baumann, Chief Medical Officer of MOLOGEN AG commented: "Lefitolimod on top of ART did not show the desired effect on the viral reservoir. However, this study provides important positive findings with regard to the effects of the reactivation of the immune system, also in HIV. These data together with the favorable safety profile of lefitolimod now confirmed also in HIV form the basis for our future development strategy for lefitolimod in combination therapies. We are confident that lefitolimod can be an important component of therapeutic approaches aiming to cure HIV."

A more extensive evaluation of the TEACH data is currently ongoing. Detailed TEACH study results of the extension phase will be presented at an international scientific conference.

MOLOGEN's ongoing development programs, especially the pivotal IMPALA study in the indication of colorectal cancer, are running independently from these study results, given these are different indications.

Reference: ¹ Vibholm et al., Clinical Infectious Diseases, 2017, 64, 1686-95 - Link to article.

About TEACH
TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) is a non-randomized interventional phase Ib/IIa trial to evaluate lefitolimod in HIV positive patients under antiretroviral therapy (ART). In the first part of the study, 15 participants received four weeks of lefitolimod therapy (60 mg s.c. twice weekly). The extension phase included 12 patients under ART, who were treated for 24 weeks with lefitolimod. After completion, nine of these patients participated in an analytical antiretroviral treatment interruption (ATI) until viral rebound. ATI is an established procedure used to determine the size and reduction of the reservoir of latent infected cells which is measured via time to viral rebound. After viral rebound ART is reintroduced.

Aarhus University Hospital, Denmark conducted the trial in two hospital centers in Denmark for which it received funding from the American Foundation for AIDS research (amfAR). MOLOGEN provided the Immune Surveillance Reactivator (ISR) lefitolimod.

The primary endpoint of the first study treatment phase is the change in proportions of activated natural killer cells in patients. Secondary study endpoints include, among others, a collection of safety, virological, immunological and pharmacodynamic data. In the extension phase the change in HIV-DNA in circulating T cells was assessed as primary endpoint. Main secondary endpoints were - besides safety evaluation - changes of functional immune parameters.

HIV infects the immune system and destroys or affects the proper function of immune cells. Without antiretroviral treatment, this eventually leads to immune deficiency and the immune system can no longer fend off a wide range of infections and diseases.

HIV remains a serious worldwide health issue. According to estimates by WHO and UNAIDS (United Nations Programme on AIDS) 37 million people worldwide were living with HIV at the end of 2014. Some 2 million people became newly infected in that same year, and 1.2 million died as a result of HIV-related causes globally.

MOLOGEN AG
As a biopharmaceutical company, MOLOGEN AG is considered a pioneer in the field of immunotherapies on account of its unique compounds and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapeutic agents for the treatment of infectious diseases.

The immunotherapeutic agent lefitolimod is the company's lead product and 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 is an immune surveillance reactivator (ISR) and has the potential to be used in a variety of different indications. At present, the ISR lefitolimod is being developed for first-line maintenance treatment of colorectal cancer (pivotal study). The phase II IMPULSE study shows positive results in two pre-defined and clinically relevant subgroups of patients. A more extensive evaluation of the IMPULSE data is currently ongoing. In addition, the ISR lefitolimod is currently being investigated in an extended phase I trial in HIV and a phase I combination study with the checkpoint inhibitor Yervoy^(R) (ipilimumab). Alongside checkpoint inhibitors, lefitolimod is one of the few product candidates in the field of immuno-oncology that is close to market. MOLOGEN's pipeline focuses on new innovative immunotherapies to treat diseases for which there is great medical demand.

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

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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 updating such information, which only represents the state of affairs on the day of publication.