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OX2 Therapeutics Receives FDA Approval for Phase I Clinical Trial to Treat High-Grade Glioblastoma with Novel Peptide Checkpoint Inhibitor (CD200AR-L); First-of-Its-Kind Peptide Also Being Developed As Platform for Possible Treatment of Other Solid Tumors

On Monday, June 8, 2020, OX2 Therapeutics, Inc. (https://ox2therapeutics.com/), a privately held Minneapolis company, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to launch a phase I clinical trial with its new combination therapy for treatment of recurrent high-grade brain tumors for which no curative therapy is available. OX2 Therapeutics has 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 (see graphic image of mechanism below). “This single peptide has the potential to replace the toxic antibody therapies that are currently used to block these immune checkpoints,” said two of the company co-founders, Chief Medical Officer Christopher Moertel (photo at end), MD, Professor, and Chief Scientific Officer Michael Olin (photo here), PhD, Associate Professor, both from the Division of Hematology/Oncology, Department of Pediatrics, in the University of Minnesota School of Medicine. Dr. Moertel is the Kenneth and Betty Jayne Dahlberg Professor in the Pediatrics Department’s Division of Pediatric Hematology and Oncology of the University of Minnesota Medical School, within the University’s Masonic Cancer Center; Medical Director of the Pediatric Neuro-Oncology and Neurofibromatosis Programs; and Clinical Neuro-Oncology Leader of the Medical School’s Brain Tumor Program. Dr. Moertel has over 25 years of experience as a neuro-oncologist, directing numerous clinical trials, has served on numerous national and local professional committees, and is the author of a number of book chapters, articles and abstracts. Special interests of Dr.Moertel include rare pediatric tumors, neurofibromatosis-associated neoplasia, and the therapy of children with brain and spinal cord tumors. Among his honors, Dr. Moertel has been named one of the “Best Doctors in America” (2007-2013) and one of the “Top Doctors” in Minnesota (2009-2018). In 2012, he was the leader of two phase I clinical trials of a glioblastoma tumor lysate vaccine.

Dr. Olin is Associate Professor in the University of Minnesota Medical School’s Department of Pediatrics, Division of Pediatric Hematology & Oncology, within the University’s Masonic Cancer Center, a comprehensive cancer center designated by the National Cancer Institute (NCI). He is also a Faculty Member of the Medical School’s Brain Tumor Program. After completing his PhD in Infectious Diseases, Dr. Olin did two postdoctoral fellowships, studying the effects of opioids on tuberculosis meningitis and brain tumor immunotherapy, and has more than nine years’ experience in translational research with two other therapies that are in clinical trials.

The third co-founder of OX2 Therapeutics is Sumant Dhawan, biotech entrepreneur, who is the Founder and Chief Scientific Officer of Cell Technology, Inc., in Mountain View, California. Mr. Dhawan received his bachelor’s degree from the University of Minnesota.

OX2 Therapeutics intends to initiate a phase I single-center, open-label, dose-escalation clinical trial in adult patients with recurrent glioblastoma (https://en.wikipedia.org/wiki/Glioblastoma). This will be followed by a pediatric trial for children with recurrent malignant brain tumors based on the drug’s 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 Dr. Olin. “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, Dr. Olin states that, 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 also being developed as a platform to be translatable to the treatment of other solid tumors.

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. Olin, Chief Scientific Officer; Dr. Moertel, Chief Medical Officer, and Mr. Dhawan, VP Operations. Shortly after the formation of the company Jeff Liter (https://www.linkedin.com/in/jeffliter/), MBA, joined the OX2 Therapeutics team as CEO/CFO.

The company’s scientific advisory committee includes G. Elizabeth Pluhar (https://vetmed.umn.edu/bio/college-of-veterinary-medicine/liz-pluhar), DVM, PhD, Professor, Department of Veterinary Clinical Sciences, University of Minnesota College of Veterinary Medicine; Thomas Molitor (https://vetmed.umn.edu/bio/college-of-veterinary-medicine/thomas-molitor), PhD, Chair, Department of Veterinary Medicine, University of Minnesota College of Veterinary Medicine; and Yuk Sham (https://med.umn.edu/bio/integrative-biology-and-physio/yuk-sham), PhD, Assistant Professor, Department of Integrative Biology and Physiology, University of Minnesota Medical School.

“The FDA filing and IND approval of the OX2 combination of CD200AR-L and GBM6-AD were successfully filed with the qualified help of our regulatory consultant, Frestedt, Inc.,” noted Dr. Moertel.

For more information, please visit www.ox2therapeutics.com or email jeff@ox2therapeutics.com

For additional background information, please also see the March 10, 2019 BioQuick News story on the development of this novel peptide checkpoint inhibitor at http://www.bioquicknews.com/node/4938.

[Press release] [OX2 Therapeutics]

IMAGE

Graphic image depicting how OX2 Therapeutics novel peptide checkpoint inhibitor (CD200AR-L) works. Christopher Moertel, MD, Chief Medical Officer & Co-Founder of OX2 Therapeutics, with young patient.