Berlin, June 12, 2014 – Two poster presentations on clinical trials with the cancer immune therapy MGN1703 of the biotechnology company MOLOGEN AG have been accepted for presentation at the ESMO 16th World Congress on Gastrointestinal Cancer (WCGI) in Barcelona (June 25 – 28, 2014). Updated data on patients with long-term progression-free survival from the phase II IMPACT trial with MGN1703 in colorectal cancer will be presented. This poster has been selected by the ESMO committee for poster discussion. In addition, a second poster will be featured on the design of IMPALA, the subsequent pivotal study.
All abstracts from the ESMO 16th World Congress on Gastrointestinal Cancer will be published in a supplement to the Annals of Oncology journal.
Abstract details:
Abstract number: PD-0009 (used in the Exhibition Hall and in the journal)
Title: "A subgroup of metastatic colorectal cancer patients with very prolonged disease control under maintenance therapy with the TLR-9 agonist MGN1703"
Poster discussion: June 27, 2014 from 06:30 pm to 06.40 pm in the General Session Room
Poster presentation: June 27, 2014 from 10:30 am to 11:00 am and 04:30 pm to 05:00 pm in the Exhibit Hall
Abstract number: P-0268 (used in the Exhibition Hall and in the journal)
Title: "The randomized phase 3 IMPALA study: Immunomodulatory maintenance therapy with TLR-9 agonist MGN1703 in patients with metastatic colorectal carcinoma"
Poster presentation: June 27, 2014 from 10:30 am to 11:00 am and from 04:30 pm to 05:00 pm in the Exhibit Hall
For more information on the ESMO 16th World Congress on Gastrointestinal Cancer please visit ESMO’s website www.esmo.org.
About IMPACT
IMPACT (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with Disease Control after Initial First-line Therapy) was a phase 2, 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 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
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Sebastian Bucher
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Fax: +49 - 40 - 60 91 86 -16
sebastian.bucher@kirchhoff.de
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