Berlin, March 30, 2015 – Biotechnology company MOLOGEN presented detailed pharmacokinetic (PK) and pharmacodynamic (PD) data from a phase I study with the cancer immunotherapy MGN1703 in healthy volunteers. These were shown in comparison to data from two clinical trials with cancer patients. The findings support the application scheme of the ongoing studies IMPULSE in small cell lung cancer and IMPALA in colorectal cancer. The comprehensive data set was shown for the first time within a poster presentation at the 2nd Immunotherapy of Cancer Conference (ITOC-2) in Munich, Germany.
The poster presented was titled “The immunotherapeutic TLR9 agonist MGN1703 – Pharmacokinetic and pharmacodynamic data from healthy volunteers and cancer patients”. PK and PD data are important parameters for the administration of drugs as they allow conclusions on the optimum dosing which leads to the best effect of a drug.
The presented data revealed that healthy volunteers and cancer patients showed similar results concerning the appearance of MGN1703 in the blood (PharmacoKinetics) and the onset of the immune activation (PharmacoDynamics). In both, healthy and cancer diseased study participants treated with MGN1703, the PD profile was following the PK profile as expected, confirming a broad immune activation.
The analysis was based on a comparison of the data from a single dose phase I trial with 60mg MGN1703 in healthy volunteers with the data of two clinical trials evaluating single and multiple administration of up to 60mg MGN1703 in cancer patients. Notably, multiple administrations resulted in similar activation levels without accumulation of MGN1703 in the blood circulation. The findings proved that the dose of 60mg MGN1703 is efficient both in healthy volunteers and cancer patients. Furthermore, they support the twice-weekly application scheme which is used in the ongoing phase II and phase III studies IMPULSE and IMPALA. In both studies patients are currently treated with 60mg MGN1703 twice weekly.
“These findings confirm the application scheme and dosing of MGN1703 in our registration study IMPALA in metastatic colorectal cancer. Twice weekly subcutaneous injections are safe and effective in broadly activating the immune system, with the potential of long-lasting benefit in some cancer patients”, said Dr. Matthias Schroff, CEO of MOLOGEN.
IMPALA is a randomized, international, multicenter, open-label phase III trial. The study aims to prove that a switch maintenance therapy with the immunotherapy MGN1703 can lead to an increased overall survival of patients who have achieved a response during their first line treatment of metastatic colorectal cancer. IMPALA started to treat the first patient in mid-September 2014 and is currently recruiting patients.
For more information on the IMPALA trial please visit www.clinicaltrials.gov.
About MGN1703
MGN1703 is an innovative DNA-based TLR9 agonist developed by MOLOGEN. It broadly activates the immune system. This activation can be utilized to enable the immune system to better recognize and combat cancer cells. Due to this mechanism of action, MGN1703 can be applied to different indications of cancer.
MOLOGEN AG
MOLOGEN AG is a biotechnology company specialized in the research and clinical development of cancer immunotherapies and DNA vaccines against infectious diseases.
The cancer immunotherapy MGN1703 is the company’s lead product and best-in-class TLR9 agonist. It is currently developed for first-line maintenance treatment of colorectal cancer (pivotal randomized trial) and small cell lung cancer (randomized controlled trial). A 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
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