June 08, 2020, OX2 Therapeutics, Inc, a privately held Minneapolis company, announced that “”it has received clearance from the U.S. Food and Drug Administration to launch a phase 1 clinical trial with its new combination therapy for treatment of recurrent high grade brain tumors for which no curative therapy is available.
OX2 Therapeutics developed the first of its kind peptide platform that targets the activation receptor of the CD200 immune checkpoint. The peptide activates the immune system through a mechanism that modulates the suppressive effects of the CD200, PD-1/PD-L1 and CTLA4 immune checkpoints to allow a more robust anti-tumor response. “This single peptide has the potential to replace the toxic antibody therapies that are currently used to block these immune checkpoints,” said Drs. Moertel and Olin. OX2 Therapeutics intends to initiate a phase I single center, open-label, dose-escalation clinical trial in adult patients with recurrent glioblastoma.
This will be followed by a pediatric trial for children with recurrent malignant brain tumors based on its safety and pharmacokinetic profile. “The FDA approval of our IND application to proceed to human trials is another important milestone for OX2 Therapeutics and the Brain Tumor Program at the Masonic Cancer Center, University of Minnesota,” stated Michael Olin, PhD. “We are looking forward to evaluating the safety of our peptide (CD200AR-L) combined with our brain tumor initiating cell tumor lysate (GBM6-AD).”
In addition, he states, although this new breakthrough therapy is currently being evaluated on CNS tumors, the number one cause of cancer-related mortality in children, this first of its kind peptide is being developed as a platform to be translatable to the treatment of other solid tumors.
About OX2 Therapeutics, Inc.
OX2 Therapeutics is a clinical stage, biopharmaceutical company developing new therapies to turn cancers into manageable and potentially curable diseases. OX2 Therapeutics was founded in 2016 by Dr. Michael Olin, PhD, Associate Professor, Christopher Moertel, MD, Professor, both from the Division of Hematology/Oncology, Department of Pediatrics, in the University of Minnesota School of Medicine and Sumant Dhawan, VP Operations. Shortly after the formation of the company Jeff Liter joined the team as CEO/CFO.The scientific advisory committee includes G. Elizabeth Pluhar, D.V.M., PhD, Thomas Molitor, PhD and Yuk Sham, PhD. “The FDA filing and IND approval of the OX2 combination of CD200AR-L and GBM6-AD was successfully filed with the qualified help of our regulatory consultant, Frestedt, Inc.,” noted Dr. Moertel.”
