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July 14, 2016

MD Anderson recruits first patient in combination study with lefitolimod and Yervoy

German-based biotech company Mologen has announced enrolment of the first patient by its collaborator, the University of Texas MD Anderson Cancer Center (MD Anderson) for a phase I study to evaluate the combination of ISR lefitolimod (MGN1703) and checkpoint inhibitor Yervoy to treat advanced solid malignancies.

German-based biotech company Mologen has announced enrolment of the first patient by its collaborator, the University of Texas MD Anderson Cancer Center (MD Anderson) for a phase I study to evaluate the combination of ISR lefitolimod (MGN1703) and checkpoint inhibitor Yervoy to treat advanced solid malignancies.

The collaboration between Mologen and MD Anderson began earlier this year on the idea that the combination of the two immunotherapies could lead synergistic effects that could activate the immune system.

MD Anderson is conducting the trial and will recruit around 50-60 patients at its centre in Houston Texas, while Mologen is providing the ISR lefitolimod (MGN1703).

Patient recruitment is expected to be completed at the beginning of 2018.

"We hope to show that the combination of Yervoy with lefitolimod will demonstrate improved therapeutic responses compared to the use of either monotherapy alone."

For the first time, ISR lefitolimod is evaluated in combination with a checkpoint inhibitor.

The study intends to initially find the highest tolerable dose of lefitolimod (MGN1703) that can be given in combination with ipilimumab (Yervoy) to patients suffering with advanced tumours.

The safety of this drug combination will be analysed.

Furthermore, this trial intends to analyse the efficacy of the combination of these two therapies in an expansion phase.

Lefitolimod (MGN1703) is a TLR9 agonist that activates immune surveillance, which can trigger the body’s own cancer-fighting mechanisms.

Ipilimumab (Yervoy) is manufactured by Bristol-Myers Squibb Co and is a recombinant, human monoclonal antibody and immune checkpoint inhibitor that has been approved for treatment of patients with unresectable or metastatic melanoma.

Mologen CEO Dr. Mariola Söhngen said: “To treat the first patient is an important milestone. We hope to show that the combination of Yervoy with lefitolimod will demonstrate improved therapeutic responses compared to the use of either monotherapy alone.

"We also strongly believe that the combination of different immunotherapies will be of benefit in a number of patients."

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