DGAP-News: MOLOGEN AG: First combination trial with MGN1703

DGAP-News: MOLOGEN AG / Key word(s): Alliance/Study MOLOGEN AG: First combination trial with MGN1703 and a checkpoint inhibitor in collaboration with MD Anderson 19.01.2016 / 08:09 The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- PRESS RELEASE N 1 / 2016 of 01/19/2016 MOLOGEN AG: First combination trial with MGN1703 and a checkpoint inhibitor in collaboration with MD Anderson Berlin, 19 January 2016 - The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) today announced that it has entered into a collaboration agreement with The University of Texas MD Anderson Cancer Center (MD Anderson). The agreement relates to a phase I trial with MOLOGEN's immunomodulator lefitolimod (MGN1703) in combination with the immunotherapy Yervoy(R) (ipilimumab) in patients with advanced solid malignancies. This is the first time that lefitolimod (MGN1703) will be evaluated in combination with a checkpoint inhibitor. Should MGN1703 succeed in augmenting the efficacy of immune checkpoint blockade, the potential applications of the compound could be broadened. This study has been initiated based on the idea that the combination of these two immunotherapies could have synergistic effects by a broader activation of the immune system. The aim of the study titled "A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies" is to initially find the highest tolerable dose of lefitolimod (MGN1703) that can be given in combination with Yervoy(R) (ipilimumab) to patients with advanced tumors. The safety of this drug combination will also be studied. Furthermore, this trial aims to evaluate the efficacy of the combination of these two therapies in an expansion phase. The combination of a TLR9 agonist and a checkpoint inhibitor is of particular interest: lefitolimod (MGN1703) broadly activates the immune system and enables it to fight cancer. Yervoy(R), 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. "We are excited about the opportunity to study this combination. Our hope is not only to define a safe dose but understand if the combination will have activity and further understand the underlying biology of these drugs", said Dr. David S. Hong, Deputy Chair and Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center, and principal investigator of the study. Dr. Alfredo Zurlo, Chief Medical Officer (CMO) of MOLOGEN AG commented: "Our study program with lefitolimod as monotherapy in colorectal and lung cancer is well on track. We are now moving to explore for the first time the combination of MGN1703 with a checkpoint inhibitor. Yervoy(R) monotherapy can dramatically improve the outcome of a minority of melanoma patients; we hope to show that the combination with MGN1703 can expand both the frequency and potency of these responses." "We look forward to learning more about this combination as ipilimumab and MGN1703 each target distinct, yet essential components of the immune system necessary to reject tumors. Boosting both of these arms in concert has shown improved therapeutic responses in pre-clinical models relative to either monotherapy alone", said Dr. Michael Curran, Assistant Professor, Department of Immunology, MD Anderson Cancer Center, and collaborator on the study. MD Anderson will conduct the trial with around 50-60 patients at its center in Houston Texas, US. MOLOGEN will provide the immunomodulator lefitolimod (MGN1703). The study will open for patient enrollment within the next few weeks. 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 MGN1703 triggers a broad and strong activation of the immune system. Due to this mechanism of action, MGN1703 has the potential to be applied to various indications. 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 a phase I study in HIV. 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(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG. 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 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. --------------------------------------------------------------------------- 19.01.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: MOLOGEN AG Fabeckstraße 30 14195 Berlin Germany Phone: 030 / 841788-0 Fax: 030 / 841788-50 E-mail: presse@mologen.com Internet: www.mologen.com ISIN: DE0006637200 WKN: 663720 Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of News DGAP News Service --------------------------------------------------------------------------- 430523 19.01.2016