OX2 Therapeutics receives FDA approval for a Phase I Clinical trial to treat High Grade Glioblastoma

FDA Grants IND Approval to OX2 Tx to Proceed in a Phase I Clinical trial of its Peptide Checkpoint Inhibitor for Patients with Central Nervous System Tumors

MINNEAPOLIS, MN, USA, June 8, 2020 /EINPresswire.com/ — OX2 Therapeutics, Inc, a privately held Minneapolis company, announced today 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 OX2 Therapeutics receives FDA approval for a Phase I Clinical trial to treat High Grade Glioblastoma 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.

OX2’S INVESTIGATION TEAM

• Dr. Michael Olin, PhD, inventor and co-founder of OX2 Therapeutics. Dr. Olin is an Associate Professor in the Division of Pediatric Hematology and Oncology at the University of Minnesota. After completing his PhD in Infectious Diseases, he did two postdoctoral fellowships, studying the effects of opioids on tuberculosis meningitis and brain tumor immunotherapy and has more than 12 year’s experience in translational research with two other therapies that are in clinical trials.
• Dr. Christopher L. Moertel, MD, co-founder of OX2 Therapeutics. Dr. Moertel is an Professor in the Division of Pediatric Hematology and Oncology and holder of the Dahlberg Professorship of Pediatric Brain Tumor Research in the University of Minnesota Medical School. 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 include rare pediatric tumors, neurofibromatosis-associated neoplasia, and the therapy of children with brain and spinal cord tumors.
• Dr. Thomas Molitor, PhD.,Dr. Molitor is a leader in immunology and virology. Dr. Molitor received his BA in Biology/chemistry followed with a masters and PhD in Microbiology, and a Postdoctoral position in Virology at Yale. He has received funding from various agencies including NIH since his first USDA grant in 1983. His research training is in virology and immunology and maintains a laboratory at the College of Veterinary Medicine using animal model systems and cell systems. He have extensively investigated various aspects of the host response process, including macrophage and T cell effector activities. In addition we have examined the maternal effects on development of the neonatal immune response. His lab has published extensively (earlier) on diagnostic methods for virus detection. Dr. Molitor is the director of the NIH T32 training program for the past 19 years and trained 17 postdoctoral and visiting fellows, 18 doctoral students and 5 Master’s students to completion of degrees and served on the graduate committees of approximately 100 additional doctoral students. In addition, he is the director of the NIH R25 summer research program. The goal of the R25 summer program is to provide high quality research experience along with skills and educational techniques that necessary to apply for graduate or professional schools to those underrepresented students of diversity. In addition to research, he has had major administrative positions over the past 8 years as department chair of a 72 faculty clinical and research department. This position affords me the opportunity to help lead the development of faculty as future scientist and clinicians.
• Dr. G. Elizabeth Pluhar, D.V.M., PhD, Member, OX2 Therapeutics Scientific Advisory Board. Dr. Pluhar is a veterinary neurosurgeon and Associate Professor in the Department of Veterinary Clinical Services at the University of Minnesota. Dr. Pluhar has collaborated with Dr. Olin for more than 6 years in the development of novel immunotherapies for canines with CNS tumors and conditions affecting the brain, spinal cord, peripheral nerves and supporting structures in canines. Together, Drs. Olin and Pluhar are successfully testing the safety and efficacy of the OX2 inhibitor in a canine high-grade brain tumor clinical trial.
• Dr. Yuk Sham, PhD. Dr. Sham is the Director of Graduate Studies for the Bioinformatics and Computational Biology Graduate Program and an Assistant Professor at the Department of Integrative Biology and Physiology at University of Minnesota Medical School. Dr. Sham received his Ph.D. in Computational Chemistry under the mentorship of the 2013 Nobel Laureate in Chemistry. As a postdoctoral fellow, he was a member of the IBM BlueGene team that designed the world’s fastest supercomputer which was awarded the US National Medal of Technology and Innovation in 2009. His research focuses on developing consistent and accurate computational models to expedite drug discovery and development. Dr. Sham has over 15 years of experience developing novel therapeutics against infectious diseases and cancer. Since 2018, Dr. Sham has been collaborating with Dr. Olin in developing the next generation of OX2 therapeutics.

   

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