MOLOGEN AG: Grant to collaboration partner for combination study in HIV with lead product lefitolimod

The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that its partner, the Danish Aarhus University Hospital, has received a grant of USD 2.75 million from the biopharmaceutical company Gilead Sciences, Inc., Foster City, US. The grant should fund a planned clinical study in HIV-positive patients on antiretroviral therapy (ART) evaluating MOLOGEN’s TLR9 agonist, the Immune Surveillance Reactivator (ISR) lefitolimod in combination with novel virus-neutralizing antibodies developed by Rockefeller University, New York, US. MOLOGEN would provide lefitolimod for the study. This novel combination to be investigated in the planned study would offer the latest variant of the "kick-and-kill” concept to treat HIV.

Dr. Mariola Söhngen, CEO of MOLOGEN, said: "In addition to our ongoing TEACH study this innovative approach could help us to further evaluate the potential of lefitolimod in HIV. Lefitolimod would be combined with novel antibodies. Due to its mode of action we strongly believe that the combination of different compounds could be of benefit in a number of patients.”

New approach of the "kick-and-kill” concept

The rationale for the novel combination is that the two compounds with their different modes-of-action synergize to generate a more effective attack and killing of the HIV reservoir compared to current standard HIV treatment regiments, i.e. antiretroviral therapy (ART). The efficacy of lefitolimod in "kick-and-kill” is currently established in the ongoing phase I TEACH study in HIV-infected patients at Aarhus University Hospital with Associate Professor Ole Søgaard as principal investigator. Treatment with lefitolimod leads to broad immune system activation as shown by the increased activation of antiviral immunity. The broadly neutralizing antibodies act via inactivation of the virus and virus producing cells in the patient’s body to prevent further infection and eliminate infected cells. Lefitolimod and the new antibodies have been tested individually; no combination studies were conducted so far.

HIV infects the immune system and destroys or affects the proper function of immune cells. Without antiretroviral treatment, this eventually leads to acquired immune deficiency syndrome (AIDS) 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 2015. Some 2 million people became newly infected in that same year, and 1.1 million died as a result of HIV-related causes globally.

MOLOGEN AG

With new and unique technologies and active substances, the biotech company MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a focus on immuno-oncology, MOLOGEN also develops immunotherapies for the treatment of infectious diseases.

The cancer immunotherapy lefitolimod (MGN1703) is the company’s lead product and best-in-class TLR9 agonist. Treatment with lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mode of action, namely to reactivate the monitoring function of the immune system, lefitolimod (MGN1703) can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. ISR lefitolimod (MGN1703) is currently being developed for first-line maintenance treatment of colorectal cancer (pivotal study) and small cell lung cancer (randomized controlled trial). Furthermore, it is also being investigated in an extended phase I study in HIV and a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy^®). Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III clinical trial (IMPALA) in the field of immuno-oncology and close to reaching the market.

MOLOGEN’s pipeline focus is on new, innovative immunotherapies to treat diseases for which there is a high medical need.

www.mologen.com

Memberships in associations:

Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA - Society for chemical technology and biotechnology e.V. | German industrial association of biotechnology (DIB) | Association for the Promotion of Science and Humanities in Germany | Association of German biotechnology companies (VBU) | Association of researching manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical industry e.V. (VCI)

MOLOGEN^®, dSLIM^®, EnanDIM^® and MIDGE^® are registered trademarks of MOLOGEN AG.

Note about risk for future predictions

Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation.

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