On March 9, 2021 OncoSynergy, Inc., a physician-founded oncology company committed to advancing therapeutics to address dire unmet medical needs, reported that the first patient was treated in the Company’s First-in-Human Phase 1 clinical trial evaluating OS2966 for the treatment of recurrent glioblastoma at Moffitt Cancer Center in Tampa, Florida (Press release, OncoSynergy, MAR 9, 2021, View Source [SID1234576359]). OS2966 is a first-in-class immunotherapy, and the first ever anti-CD29 (beta 1 integrin) therapeutic to reach human trials.
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"Glioblastoma is a devastating brain cancer with few treatment options. Its invasive growth pattern, propensity for rapid treatment resistance, and the presence of the blood-brain-barrier (BBB) preventing many therapeutics from reaching the site of disease, makes successful treatment of glioblastoma one of the biggest challenges facing oncologists and neurosurgeons," said OncoSynergy Co-Founder and Chief Executive Officer, Anne-Marie Carbonell, MD. "After a decade developing and demonstrating the pre-clinical potential of OS2966 in the most difficult to treat cancers, we are thrilled to have treated our first patient in a study specifically designed to overcome these challenges."
OS2966 is a monoclonal antibody blocking CD29, a critical cell surface receptor governing multiple fundamental biological processes driving cancer growth, invasiveness, and resistance. In OncoSynergy’s First-in-Human Phase 1 trial, OS2966 is delivered directly to the patient’s brain tumor by convection-enhanced delivery (CED), a minimally invasive technique used to bypass the BBB. As CED involves placement of one or more catheters, OncoSynergy has partnered with Infuseon Therapeutics, a Cleveland Clinic spinout company and is utilizing Infuseon’s Cleveland Multiport Catheter to deliver OS2966.
Patients enrolled in the study must have recurrence or progression of their disease which requires tumor resection. Incorporating tumor resection into the trial design allows for acquisition of therapeutic-infused tumor tissue enabling researchers to perform critical studies that provide additional near real-time information on how the drug performs as well as inform dosing.
"Surgical removal of a glioblastoma tumor alone is not curative because tumor cells infiltrating into the surrounding brain cannot be safely removed. The fact that nearly all therapeutics cannot cross the blood-brain-barrier to get to those residual tumor cells means that there is an opportunity for neurosurgeons to become more involved in the therapeutic development process," said Michael Vogelbaum, MD, PhD, Program Leader of Neuro-Oncology and Chief of Neurosurgery at Moffitt Cancer Center. Dr. Vogelbaum continued, "Trials that consider the importance of successful delivery of a therapeutic, like OncoSynergy’s OS2966, to treat glioblastoma will provide an advantage to improving patient outcomes." Dr. Vogelbaum is also the Chief Medical Officer of Infuseon Therapeutics and inventor of the Cleveland Multiport Catheter. His role as the Primary Investigator of OncoSynergy’s trial is addressed under a conflict-of-interest management plan approved by Moffitt Cancer Center.