MOLOGEN AG announced that it has entered into a collaboration agreement with The University of Texas MD Anderson Cancer Center (MD Anderson). The agreement relates to a phase I trial with MOLOGEN's immunomodulator lefitolimod (MGN1703) in combination with the immunotherapy Yervoy® (ipilimumab) in patients with advanced solid malignancies. This is the first time that lefitolimod (MGN1703) will be evaluated in combination with a checkpoint inhibitor.

Should MGN1703 succeed in augmenting the efficacy of immune checkpoint blockade, the potential applications of the compound could be broadened. This study has been initiated based on the idea that the combination of these two immunotherapies could have synergistic effects by a broader activation of the immune system. The aim of the study titled “A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies” is to initially find the highest tolerable dose of lefitolimod (MGN1703) that can be given in combination with Yervoy® (ipilimumab) to patients with advanced tumors.

The safety of this drug combination will also be studied. Furthermore, this trial aims to evaluate the efficacy of the combination of these two therapies in an expansion phase. The combination of a TLR9 agonist and a checkpoint inhibitor is of particular interest: lefitolimod (MGN1703) broadly activates the immune system and enables it to fight cancer.

Yervoy®, manufactured by Bristol-Myers Squibb Co., is a recombinant, human monoclonal antibody and immune checkpoint inhibitor approved to treat patients with unresectable or metastatic melanoma. MD Anderson will conduct the trial with around 50-60 patients at its center in Houston Texas, US. MOLOGEN will provide the immunomodulator lefitolimod (MGN1703).

The study will open for patient enrollment within the next few weeks.