PRESS RELEASE N 19 / 2019 of 11/04/2019

MOLOGEN AG announces start of phase IIa TITAN combination study in HIV

Berlin, 4 November 2019 - The biopharmaceutical company MOLOGEN AG
(ISIN DE000A2LQ900, SIN A2L Q90) today announced that its collaborators, the team of Dr Ole Schmeltz Søgaard, MD PhD, Associate Professor from the Aarhus University Hospital in Denmark, has dosed the first participants in the phase IIa TITAN combination study in HIV. The study will investigate the combination of the TLR9 agonist lefitolimod with innovative, virus-neutralizing antibodies aiming for a delay in viral rebound. These antibodies were developed by Rockefeller University in New York, USA. The investigator-initiated study is being funded by Gilead Sciences, California/USA, a leading pharmaceutical company in the field of HIV/AIDS.

"We are obviously very excited to be enrolling first participants in this innovative randomized trial. The placebo-controlled study design allows us to dissect the impact of two types of very promising investigational drugs on the HIV reservoir and the immune system", said Prof Dr Ole Schmeltz Søgaard, principle investigator in the TITAN study.

Chief Medical Officer, Dr. Matthias Baumann stated: "We are delighted to announce the start of this phase IIa combination trial with our TLR9 agonist lefitolimod. The TITAN study builds on the learnings from our TEACH trial and is an important step in our new strategy to investigate lefitolimod in combination approaches also in HIV."

In the phase Ib/IIa TEACH study, lefitolimod was tested as a monotherapeutic approach on top of standard anti-retroviral therapy or ART in HIV patients. There was clear evidence for the impressive effects of lefitolimod in regard to the reactivation of the immune system. These data, coupled with the confirmed favorable safety profile, forms the basis for even more advanced therapeutic combination strategies, e.g. the TITAN study. The hypothesis in the TITAN trial is that the combination of lefitolimod and the broadly neutralizing monoclonal antibodies will boost immunological control of the HIV infection and lead to a delay in time to viral rebound once participants interrupt their regular HIV medication.
 

About the TITAN study
The study titled "Combining a TLR9 Agonist with Broadly Neutralizing Antibodies for Reservoir Reduction and Immunological Control of HIV Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial" is a randomized, double-blind, placebo-controlled study and is conducted by Aarhus University, Denmark. The study is designed to evaluate the safety and efficacy of lefitolimod in combination with broadly neutralizing antibodies in HIV-infected patients receiving ART aiming to reduce the HIV reservoir.

Forty-eight patients will participate in the study; randomization and dosing of participants began on 30 October 2019. The study is expected to be completed in early 2021.
 

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 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.

 

Contact
Investor Relations & Corporate Communications
Tel: 7 88 - 37
Fax: 7 88 - 50

 

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.