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Glioblastoma and Calidi Biotherapeutics: A Pioneering Partnership Heightens the Commercialization Potential of a Therapeutic to Treat an Aggressive Brain Tumor

We are encouraged by the method and biology of this novel biologic and inspired by the hope it might bring glioblastoma patients.”

Prof. Maciej LesniakThe most common malignant brain tumor, glioblastoma often brings intensifying headaches, nausea, vomiting, and seizures. It also carries a dismal prognosis – one unchanged for decades despite accelerating levels of research into the aggressive cancer. Glioblastoma survival is measured in months, not years. The bleak outlook drains spirits and invites mortality closer than anyone would like.

Northwestern University neurosurgeon Dr. Maciej Lesniak has devoted much of his career to improving the outlook for glioblastoma patients, including steering the development of a novel biologic.

Over the past five years, Northwestern sponsored a Phase 1 clinical trial led by Dr. Lesniak to test an oncolytic viral therapy for glioblastoma developed in collaboration with cancer-fighting researcher Dr. Karen Aboody. Northwestern directed the Investigational New Drug Application to the U.S. Food and Drug Administration to initiate the regulatory approval of this novel therapeutic.

Sparked by the publication of the initial trial’s encouraging results in 2021, INVO struck a first-of-its-kind partnership with California-based Calidi Biotherapeutics to commercially license the Phase I clinical data. This groundbreaking agreement, an evolution of INVO’s licensing practices and the first time Northwestern ever licensed clinical data, enables Calidi to pursue further translational development of the therapy in a Phase II clinical trial.

Over the last century, the FDA has approved only three treatments for glioblastoma. Lesniak and Calidi maintain hope their therapeutic will be the fourth, transforming glioblastoma treatment and elevating patient survival rates in the process.

“While one’s degree of enthusiasm has to be tempered by the realities of clinical trials, we are nevertheless encouraged by the method and biology of this novel biologic and inspired by the hope it might bring glioblastoma patients.” -- Dr. Maciej Lesniak, the Michael J. Marchese Professor and Department of Neurological Surgery Chairman, Feinberg School of Medicine