Mologen: First Patient Recruited In Combination Study With Lefitolimod And Yervoy

BERLIN--(BUSINESS WIRE)--The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that its collaborator, the University of Texas MD Anderson Cancer Center (MD Anderson), has enrolled the first patient in the combination study (FPI: first patient in) with a checkpoint inhibitor. In the phase I study MOLOGEN’s TLR9 agonist, the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703) is tested in combination with the immunotherapy ipilimumab (Yervoy^®) in patients with advanced solid malignancies. The collaboration has been initiated in January 2016 based on the idea that the combination of these two immunotherapies could have synergistic effects leading to a broader activation of the immune system. MD Anderson is conducting the trial and will recruit around 50-60 patients at its center in Houston Texas, US. MOLOGEN is providing the ISR lefitolimod (MGN1703). Patient recruitment is expected to be completed at the beginning of 2018.

“A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies”

This will be the first time ISR lefitolimod is evaluated in combination with a checkpoint inhibitor. The aim of the combination study is to initially find the highest tolerable dose of lefitolimod (MGN1703) that can be given in combination with ipilimumab (Yervoy^®) to patients with advanced tumors. The safety of this drug combination will also be analyzed. Furthermore, this trial aims to evaluate the efficacy of the combination of these two therapies in an expansion phase. Lefitolimod (MGN1703) is a TLR9 agonist that by broadly activating immune surveillance can trigger the body’s own cancer-fighting mechanisms.

The commercially available ipilimumab (Yervoy^®), manufactured by Bristol-Myers Squibb Co., is a recombinant, human monoclonal antibody and immune checkpoint inhibitor approved to treat patients with unresectable or metastatic melanoma. This combination of an immune surveillance reactivator with a checkpoint inhibitor is of particular interest to the field of immunotherapy.

“We are very pleased by the start of this combination study. It will be exciting to learn more about this combination therapy given the positive findings in pre-clinical models”, said Dr. David S. Hong, Deputy Chair and Associate Professor, Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, and principal investigator of the study.

“To treat the first patient is an important milestone. We hope to show that the combination of Yervoy^® with lefitolimod will demonstrate improved therapeutic responses compared to the use of either monotherapy alone. We also strongly believe that the combination of different immunotherapies will be of benefit in a number of patients. If successful, we could substantially broaden the potential applications of lefitolimod”, said Dr. Mariola Söhngen, CEO of MOLOGEN.

About the combination study lefitolimod (MGN1703) with the checkpoint inhibitor Yervoy^®

The study titled “A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies” is conducted by MD Anderson Cancer Center (MD Anderson). MOLOGEN provides the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703) and funds the study. Around 50-60 patients will participate in MD Anderson Cancer Center in Houston, Texas, USA. Patient recruitment began in July 2016 and is expected to be completed at the beginning of 2018.

The primary aim of the study is to ascertain the best tolerable dosage for administering lefitolimod (MGN1703) in combination with Yervoy^®. The safety of this combination therapy will also be investigated and an expansion phase is planned to evaluate the efficacy of this combination therapy.

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)

MIDGE®, dSLIM®, EnanDIM® and MOLOGEN® 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.