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The blood brain barrier (BBB) prevents most promising new therapeutic drugs from reaching their targets in brain tumors. Multiple approaches have been used to overcome this obstacle to successful treatment, and to date, there has been only limited clinical success. One approach is to bypass the BBB, that is to introduce therapies directly into brain tumors and tumor-infiltrated brain tissue. A long-investigated approach to direct delivery is called “convection enhanced delivery”, or CED. CED involves the placement of one or more catheters into brain tumors and tumor-infiltrated brain in order to slowly pump a therapy into the tissue.  These therapies may range from conventional drugs that are given systemically (and by delivering them directly, the toxicity that they cause to the body is avoided) or novel "biological" therapies, such as viral gene therapies or antibodies that cannot be given via traditional oral or IV routes.

Oncosynergy is a startup biotechnology company that has developed a therapeutic antibody that attacks one of the fundamental mechanisms by which brain cancer cells grow and spread in the brain. They are conducting a first-in-human clinical trial of their antibody (OS2966) that will be delivered via a type of catheter that was developed specifically for direct delivery into the brain, the Cleveland Multiport Catheter (CMC).

Patients with recurrent GBM who enroll in this clinical trial will undergo a biopsy to confirm tumor recurrence followed by implantation of one CMC catheter and infusion of OS9266 for four hours while being monitored by MRI. They next undergo a craniotomy to remove the recurrent brain tumor, which will be evaluated for the effects of the treatment, and implantation of two CMCs into tumor-infiltrated brain surrounding the tumor. OS9266 will be infused into these areas over another four hours and then the catheters will be removed. Patients will continue to be evaluated with intermittent MRIs to determine how effective the OS9266 antibody is at preventing further progression of their disease. 

Dr. Vogelbaum is the inventor of the CMC and has a financial interest in the company, Infuseon Therapeutics, that is marketing the CMC. Dr. Vogelbaum does not have a financial interest in OncoSynergy.

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