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Mologen AG (MOLGF.PK): Cancer Immune Therapy MGN1703 Shows Outstanding Long-Term Responses



6/30/2014 9:30:39 AM

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• Two presentations at ESMO WCGI 2014
• Three MGN1703 patients still progression-free
• Pivotal IMPALA trial to start recruitment


Berlin, June 30, 2014 – Two posters about the cancer immune therapy MGN1703 of the biotechnology company MOLOGEN AG have been presented at the ESMO 16th World Congress on Gastrointestinal Cancer (WCGI) in Barcelona. In the first one data on four patients in colorectal cancer were presented. These patients continued treatment with the immunotherapy MGN1703 after the end of the IMPACT study in compassionate use programs. Three of these patients are still free of progression of their disease in excess of 32 to 40 months. This highlights the long-term efficacy and safety of prolonged treatment with MGN1703. In the second poster, the study design of the confirmatory IMPALA trial has been presented. All the evidence from the IMPACT study results has been integrated. Patient recruitment will start in the third quarter 2014.

IMPACT was a phase II, randomized, placebo-controlled, double-blind and multicenter clinical study. Notably, some tumor responses on MGN1703 monotherapy were observed during the study, two of these being observed as late as nine months after induction chemotherapy was interrupted and MGN1703 treatment started. At the end of the study four patients, all from the MGN1703 arm, were still free of progression and continued treatment on MGN1703 monotherapy in compassionate use programs. The outcome of these patients was reported in the poster "A subgroup of metastatic colorectal cancer patients with very prolonged disease control under maintenance therapy with the TLR-9 agonist MGN1703".

Three of these four patients were still progression-free for 32, 36 and 40 months as of April 2014 and continue treatment with MGN1703. This prolonged disease control is the more remarkable knowing that median overall survival for metastatic colorectal cancer is usually in the range of 24 and 30 months. It is also remarkable that no severe side effects were reported during the compassionate use programs; evidence for excellent tolerability and safety of the drug.

"One of the four long-term responders is my patient and he has the disease now for more than three years. Outstanding that he is still progression-free for such a long time. I am very pleased to see his excellent quality of life,” said Dr. Jorge Riera-Knorrenschild, Universitätsklinikum Giessen und Marburg, Marburg, Germany, one of the investigators of the IMPACT trial. “I am confident that treatment with MGN1703 will enable a very prolonged disease control for the patients. As we see, they are able to continue their normal life while being treated.”

Exploratory analyses of the IMPACT data identified a better response to MGN1703 in patients who, after induction chemotherapy, showed reduced tumor burden, normal CEA levels (tumor marker for colorectal cancer), or a certain level of activated NKT cells (Natural Killer T cells). These findings have been implemented in the pivotal IMPALA trial as inclusion criteria and stratification factors, respectively. The final results on overall survival, the secondary endpoint of the IMPACT study, are still not yet mature due to a lack of events.

On this basis IMPALA, the randomized, international, multicenter, open-label phase III trial, has been designed. The trial aims to prove that a switch maintenance therapy with an active immunotherapy leads to an increased overall survival of patients who have achieved a response during their first line treatment of metastatic colorectal cancer. The primary endpoint is overall survival and secondary study endpoints include progression-free survival, toxicity and safety, and Quality of Life (QoL). Approximately 540 patients from more than 100 European centers, including the five major pharma markets, will participate in the study.

Start of patient enrollment is expected in the next months, directly after receipt of the necessary approvals.

Leading medical associations will collaborate: Arbeitsgemeinschaft Internistische Onkologie (AIO) in Germany, Grupo Españiol de Tratamiento de Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) in France. The steering committee consists of international medical experts; among others the coordinating study investigators Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dirk Arnold, head of Klinik für Tumorbiologie Freiburg at the Albert Ludwigs University in Freiburg.

About IMPACT
IMPACT (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with Disease Control after Initial First-line Therapy) was a phase II, randomized, placebo-controlled, double-blind, multicenter clinical study aiming to determine the efficacy of MGN1703 as switch maintenance therapy following first-line chemotherapy with or without bevacizumab in patients with metastatic colorectal cancer.

Patients included in the IMPACT study had stabilization, or partial or complete remission of their disease after receiving first-line therapy for 4.5 to 6 months. During the study, patients were randomized to receive either MGN1703 or placebo twice per week. The treatment was continued until tumor progression was observed.

The primary endpoint of the study was to determine progression-free survival of the patients. Secondary study endpoints included overall survival, progression-free survival from start of induction therapy, response rates and safety, as well as collection of immunological and pharmacodynamic data.

About IMPALA
IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is an international phase III, randomized, open-label, two-arms, and multicenter clinical study. Based on the findings from IMPACT, the study will include patients with metastatic colorectal cancer who had tumor reduction after receiving first-line chemotherapy with or without biological agents. The study will include around 540 patients in eight European countries from more than 100 centers, including the five major European pharma markets.

The primary endpoint is overall survival and secondary study endpoints include progression-free survival from start of induction therapy, toxicity and safety, and Quality of Life (QoL).

About MGN1703
MGN1703 is an innovative DNA-based TLR-9 agonist developed by MOLOGEN. It broadly activates the immune system against tumor-associated antigens (TAA) which are released by cancer cells. Once activated by MGN1703, the immune system is able to overcome its fatal tolerance toward cancer cells and attacks them selectively. Due to this mechanism of action, MGN1703 can be applied to different indications of cancer.

About MOLOGEN AG
MOLOGEN AG is a biotechnology company specialized in the research and clinical development of cancer immune therapies and DNA vaccines against infectious diseases.

The cancer immune therapy MGN1703 is the company’s lead product and best-in-class TLR-9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial applied for) and lung cancer (randomized controlled trial started). Second clinical-stage product is MGN1601, a therapeutic vaccination for the treatment of renal cancer. A phase I/II clinical study has already been completed successfully.

With unique, patented technologies and innovative products, MOLOGEN is pioneering immune therapies.

MOLOGEN AG is a publicly listed company, headquartered in Berlin. The shares (ISIN DE0006637200) are listed in the Prime Standard of the German Stock Exchange.

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.

MOLOGEN AG

PRESS SERVICE:
Prof. Peter W. Huebner
Head of Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
huebner@mologen.com

INVESTOR RELATIONS:
Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com

External Investor Relations:
Kirchhoff Consult AG
Sebastian Bucher
Tel: +49 - 40 - 60 91 86 - 18
Fax: +49 - 40 - 60 91 86 -16
sebastian.bucher@kirchhoff.de

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