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Mologen AG. (9/11/14). "Press Release: Initiation of Phase III IMPALA Study with Immunotherapy MGN1703 in Colorectal Cancer".

Region Region Europe
Organisations Organisation Mologen AG
  Group Mologen (Group)
  Organisation 2 Klinik für Tumorbiologie Freiburg (KTB) (Tumor Biology Center Freiburg)
Products Product lefitolimod (MGN1703)
  Product 2 clinical research
Persons Person Cunningham, David (Royal Marsden Hospital 200909 Head Gastrointestinal Unit)
  Person 2 Nickolaus, Claudia (Mologen 201407– Head Investor Relations)
     


> First patient enrolled

> Pivotal study to evaluate overall survival


MOLOGEN AG has enrolled the first patient in the international IMPALA study. Primary objective of the phase III pivotal trial is to prove that a switch maintenance therapy with the cancer immunotherapy MGN1703 leads to an increased overall survival (OS) in patients with metastatic colorectal carcinoma.

IMPALA is a randomized, international, multicenter and controlled phase III trial expected to recruit about 540 patients from more than 100 European centers in eight European countries, including the five major pharma markets. The primary endpoint is overall survival. Secondary study endpoints include progression-free survival, Quality of Life (QoL) as well as safety and tolerability.

"We are pleased that we have already enrolled the first patient in the IMPALA trial. We are excited to learn more about the efficacy of the novel immunotherapy MGN1703," said Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London. "The trial aims to confirm the trend in overall survival along with very good safety and tolerability of MGN1703 as observed in the IMPACT trial."

"The preceding phase II IMPACT trial provided valuable findings which we used to optimize the study design of the IMPALA trial," said Prof. Dr. Dirk Arnold, head of Klinik für Tumorbiologie Freiburg at the Albert Ludwigs University in Freiburg. "The evidence on biomarkers from exploratory analyses of the IMPACT study enables us to identify those patients who will benefit most from a treatment with the immunotherapy MGN1703."

Only metastatic colorectal cancer patients who have achieved a response (partial or complete response) during their first-line treatment are eligible to participate in the IMPALA study and will be randomized 1:1 to MGN1703 or local standard treatment. Based on the evidence obtained in the IMPACT study patients will be stratified according to specific biomarkers shown after the 12-30 weeks induction therapy: normal CEA levels (tumor marker for colorectal cancer) or a certain level of activated NKT cells (Natural Killer T cells).

Patients in the experimental arm will then receive 60mg of MGN1703 monotherapy twice weekly as maintenance treatment. MGN1703 will be continued until first tumor progression. Then the induction treatment will be restarted in combination with MGN1703.

Patients in the control arm will receive any local maintenance treatment regimen. They may either continue induction therapy, halt some of the agents or interrupt all therapies. After first tumor progression the induction therapy will be restarted.

In both arms, only after second tumor progression or if no re-induction is possible for any reason, patients will stop trial treatment and start second-line therapy.

The IMPALA study is supported by leading medical associations: 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. Dr. med. Dirk Arnold, head of Klinik für Tumorbiologie Freiburg at the Albert Ludwigs University in Freiburg.

In the phase II IMPACT study, a randomized, double-blind and international trial, MGN1703 was evaluated as maintenance therapy vs. placebo in 59 metastatic colorectal cancer patients. After study closure four patients continued on MGN1703 monotherapy treatment in compassionate use programs without progression of their disease. Three of these four patients were still progression-free for 32, 36 and 40 months as of April 2014 and continue treatment with MGN1703. The final results on overall survival, a secondary endpoint of the IMPACT study, are still not yet mature due to a lack of events.

According to the World Health Organization (WHO), colorectal cancer is among the top three cancer indications worldwide and there are approx. 1.4 million newly diagnosed cases per year.

Besides metastatic colorectal cancer, MGN1703 is being developed for first-line maintenance treatment of extensive-stage small cell lung cancer, a serious cancer disease with high unmet medical need. IMPULSE, an international randomized controlled trial, is currently enrolling patients.

For more information of the IMPALA and IMPULSE trials, visit www.clinicaltrials.gov.


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, toxicity and safety, and Quality of Life (QoL).

The coordinating study investigators are Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London, and Prof. Dr. Dirk Arnold, head of Klinik für Tumorbiologie Freiburg at the Albert Ludwigs University in Freiburg.


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) and lung cancer (randomized controlled trial). 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.


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

Claudia Nickolaus
Head of Investor Relations
Tel: +49 - 30 - 84 17 88 - 86
Fax: +49 - 30 - 84 17 88 - 50
nickolaus@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.

   
Record changed: 2017-04-02

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