Press release

 

Berlin, 21 May 2010. The Berlin based biotechnology company MOLOGEN AG will present the results of its clinical phase 1b study with MGN1703 for the treatment of metastasized tumor diseases at this year’s annual meeting of the American Society for Gene and Cell Therapy (ASGCT) in Washington, DC, USA. The talk "Treatment with the TLR9 Agonist MGN1703 in Patients with Metastatic Solid Tumors - EFFICACY Results of a Phase 1b Clinical Study", will be part of the session “Oligonucleotide & RNAi Therapeutics II“ and will take place at 4:00 PM (EST) on Saturday, 22 May 2010 (Abstract 664).

 

MOLOGEN will also present clinical safety data of MGN1703 at the poster session “Oligonucleotide & RNAi Therapeutics III”: “Safety Results of a Phase 1b Clinical Study for Treatment of Patients with Advanced Solid Tumors with the TLR9 Agonist MGN1703“ (Abstract 887).

 

Furthermore, information on MGN1601, a cell-based gene therapy against renal cancer, will be introduced. Preclinical safety data as well as the efficacy of the therapy demonstrated in preclinical models will be presented at the meeting at following poster sessions:

 

­      Poster session “Cancer - Immunotherapy I“: “Safety Data of MGN1601, a Tumor Vaccine, Made of Allogeneic, Transfected and Irradiated Tumor Cells in Combination with an Immunomodulator for the Treatment of Metastatic Renal Cell Carcinoma” (Abstract 189)

 

­      Poster session “Cancer - Immunotherapy III“: “Preclinical Efficacy Data of MGN1601, a Tumor Vaccine Comprising 4−Fold Gene−Modified and Irradiated Allogeneic Tumor Cells in Combination with a DNA−Based Immunomodulator for the Treatment of Metastatic Renal Carcinoma” (Abstract 822)

 

About MGN1703

MGN1703 is based on dSLIM® (“Double Stem Loop Immunomodulator”), an innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM® activates the immune system against tumor-associated antigens by targeting various “danger” sensing receptors on certain immune cells, primarily TLR. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. Once activated by dSLIM®, the immune system is able to overcome its fatal tolerance toward cancer cells as well as towards TAA, and attacks them selectively.

 

The results of the completed phase 1b study demonstrate an excellent safety profile of MGN1703. Treatment with the investigational medicinal product was well tolerated and no dose-limiting or serious side-effects were identified.

 

Very promising signs of efficacy were also found. MGN1703 was able to delay the progression of cancer diseases by at least six weeks in many cases, including patients with advanced metastatic tumor diseases with no further standard treatment options like the ones selected for the phase 1b study.

 

In March 2010, MOLOGEN has received approval from the competent German and Austrian health authorities to conduct a continuative clinical study with MGN1703. The study is a phase 2, randomized, placebo-controlled, double-blind, multicenter clinical study to determine the efficacy and safety of subcutaneously administered MGN1703 for the treatment of metastatic colorectal cancer patients who responded to first-line therapy (IMPACT-study). The study is expected to start soon.

 

About MGN1601

The method developed by MOLOGEN to treat renal cancer with cell-based gene therapy involves therapeutic vaccination to combat advanced tumors and to prevent their reoccurrence (recidivation) after operation and medical treatment.

 

Human allogeneic renal cancer cells that have been obtained from a renal tumor and are available in a standardized and characterized cell bank (master cell bank) form the basis for the vaccination. The allogeneic cancer cells are “genetically modified” with additional genetic information and are combined with the immunomodulator dSLIM® as an adjuvant to maximize the effect of the vaccination, before they are finally injected into the patient. The genetic modification is done with the help of the DNA-based MIDGE® vectors (MIDGE® and dSLIM® are proprietary technologies of MOLOGEN).

 

In 2009, MOLOGEN has applied for the approval to conduct a clinical study with MGN1601. The purpose of the phase 1b/2a clinical study (ASET study) is to investigate the safety and efficacy of MGN1601. This will be done at different oncological clinics in Germany. 24 patients who are suffering from advanced renal cancer and with whom the standard treatment has proved to be unsuccessful are to be included in this open, single-arm, non-randomized, multi-centre, clinical proof-of-principle study. The study is expected to start within this year.