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MOLOGEN AG: First combination data of TLR9 agonists EnanDIM(R) with checkpoint inhibitor in preclinical tumor models - Seite 2

The EnanDIM(R) molecules consist entirely of natural DNA, as is also the case with lefitolimod. The main difference between MOLOGEN's two ISR families is their molecule structure. Whereas lefitolimod is dumbbell-shaped and covalently-closed, EnanDIM(R) molecules have a linear structure. However, as with lefitolimod, due to its specific structure, no chemical modification is needed in order to protect the molecules against degradation by enzymes.

The new findings support the strategy to combine TLR9 agonists with checkpoint inhibitors - which is the concept of MOLOGEN's currently ongoing phase I combination study of lefitolimod with the checkpoint inhibitor Yervoy(R) (ipilimumab) in 50 to 60 patients with advance solid malignancies. The study is conducted by the MD Anderson Cancer Center in Houston, Texas, U.S..The primary aim of the study is to determine the best tolerable dose for lefitolimod in combination with Yervoy(R). The safety of this combination therapy will also be investigated and an expansion phase is planned to evaluate the efficacy of this combination therapy.

Results of the combination of EnanDIM(R) with checkpoint inhibitors in preclinical tumor models have been presented at the 2017 Clinical Immuno-Oncology Symposium (ASCO SITC) in Orlando, U.S. (23 - 25 February 2017).

MOLOGEN AG

With new and unique technologies and active substances, the biotech company MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a focus on immuno-oncology, MOLOGEN also develops immunotherapies for the treatment of infectious diseases.

The cancer immunotherapeutic agent lefitolimod is the company's lead product and best-in-class TLR9 agonist. Treatment with lefitolimod triggers a broad and strong activation of the immune system. Due to this mode of action, namely to reactivate the monitoring function of the immune system, lefitolimod can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. The ISR lefitolimod (MGN1703) is currently being developed for first-line maintenance treatment of colorectal cancer (pivotal study) and small-cell lung cancer (randomized controlled trial). Furthermore, it is also being investigated in an extended phase I study in HIV and a phase I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)). Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III pivotal clinical trial (IMPALA) in the field of immuno-oncology and close to reaching the market.