On August 4, 2021 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, reported that it has executed a license agreement with Northwestern University for the exclusive commercialization rights to the IND and data generated from Northwestern’s Phase 1 clinical trial treating brain tumor patients with an engineered oncolytic adenovirus delivered by neural stem cells ("NSC-CRAd-S-pk7") (Press release, Calidi Biotherapeutics, AUG 4, 2021, View Source [SID1234585746]). The license is for Calidi’s commercial development of stem-cell based products loaded with adenovirus. A group of prominent neurosurgeons and neuro-oncologists led by Dr. Maciej S. Lesniak, Chair of the Department of Neurological Surgery, at Northwestern University Feinberg School of Medicine, and Dr. Roger Stupp, Chief of Neuro-Oncology in the department of Neurology at Northwestern University, has successfully completed a Phase 1, first-in-human clinical trial with NSC-CRAd-S-pk7, hereafter referred to as NeuroNova-1 (NNV-1), in patients with newly diagnosed malignant glioma. This trial resulted from a 13 year collaboration with Dr. Karen Aboody at the City of Hope Comprehensive Cancer Center, who developed the tumor-tropic neural stem cell line.
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"We share the same excitement and passion of Dr. Lesniak about the potential of NeuroNova-1," said Allan J. Camaisa, CEO and Chairman of Calidi Biotherapeutics. "This exclusive worldwide license and the upcoming Phase 2 clinical trial with NeuroNova-1 will further expand and diversify our product pipeline and portfolio, making Calidi’s solutions more versatile across a variety of cancer indications. We look forward to sharing our cell delivery expertise in future trials with a world-class institution like Northwestern University."
In preclinical models, the neural stem cells were capable of effectively targeting the delivery of the viral payload selectively to glioma cells, warranting the translation of this therapeutic approach to the clinical setting.
"Northwestern University’s neurosurgery and neuro-oncology teams are looking forward to continued collaboration with Calidi Biotherapeutics for the Phase 2 trial of NeuroNova-1," said Maciej S. Lesniak, MD, MHCM, FAANS, Professor of Neurological Surgery and Chair, Department of Neurological Surgery, Northwestern University Feinberg School of Medicine. "We chose to partner with Calidi over other companies, on account of their extensive expertise and proprietary methods in stem cell-based platforms for delivery and potentiation of oncolytic viruses. We will draw from their significant experience and expertise in this field to further enhance the next generation of NeuroNova-1."
"Our team is very pleased to help further development of NeuroNova-1," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi Biotherapeutics. "This novel agent has a significant potential for glioma treatment, especially in patients having very difficult to treat gliomas with unmethylated MGMT promoters. These promising findings have been published in the June 29, 2021 issue of the prestigious journal: Lancet Oncology." An article referencing this journal publication was recently published in Apple News: Medical Xpress, entitled: Novel therapy may improve survival for patients with malignant gliomas (Article).
Under the License Agreement, Northwestern granted to Calidi a worldwide, twelve-year exclusivity for use of the clinical data in the commercial development of NSC-CRAd-S-pk7 for therapeutic and preventive uses in oncology and a right of reference to NU IND 17365 which relates to the treatment of newly diagnosed glioma.