VAXIMM Initiates Phase I/II Trial with VXM01 Oral T-cell Immunotherapy in Combination with PD-L1 Inhibitor Avelumab in Glioblastoma
VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that the first patient has been dosed in a Phase I/II trial evaluating VXM01 oral immunotherapy in combination with avelumab*, a human anti-PD-L1 antibody, for the treatment of glioblastoma. The trial is part of a collaboration agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc.
This trial is a multicenter, open-label, Phase I/II trial (EudraCT #: 2017-003076-31) to evaluate the safety and efficacy of VXM01 in combination with avelumab in patients with recurrent glioblastoma. The trial is planned to enroll a total of 30 patients at approximately eight clinical sites in Europe. The primary objective of the study is to evaluate the safety and tolerability of VXM01 in combination with avelumab. Secondary objectives include progression-free survival and overall survival.
Prof. Wolfgang Wick, MD, Chairman, Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany, and principal investigator of the study, said: “We have already seen promising clinical results with VXM01 as a monotherapy to treat patients with progressive glioblastoma. There is a strong scientific rationale to evaluate this oral immunotherapy with a PD-L1 inhibitor as the checkpoint inhibition may enhance the activity of the vaccine. There is an urgent need to find more effective treatments to help prevent further progression of this deadly form of brain tumor, and we look forward to seeing the results of this combination trial.”
Heinz Lubenau, PhD, Chief Operating Officer and Co-Founder of VAXIMM, said: “We are very pleased that this important trial is now underway. This first collaboration with Merck KGaA, Darmstadt, Germany and Pfizer will give us great insight into the potential efficacy of the combination of these two therapeutic modalities to treat brain tumors.”
*Avelumab is under clinical investigation for the treatment of glioblastoma in combination with VXM01 and has not been demonstrated to be safe and effective for this use. There is no guarantee that avelumab will be approved for glioblastoma by any health authority worldwide.
Original Press Release.