Press Release

Calidi Biotherapeutics Announces Agreement with Northwestern University for Exclusive Commercial Rights to their IND for Treatment of Malignant Glioma

Calidi Biotherapeutics

LA JOLLA, Calif.--(BUSINESS WIRE)--Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, announced today 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”). 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.

“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.

About Calidi Biotherapeutics

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery of oncolytic viruses protected by stem cells for targeted therapy against difficult-to-treat cancers. Calidi Biotherapeutics is advancing a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. Calidi’s off-the-shelf, universal cell-based delivery platform is designed to protect, amplify, and potentiate oncolytic viruses currently in development leading to enhanced efficacy and improved patient safety. Calidi Biotherapeutics is headquartered in La Jolla, California. For more information, please visit www.calidibio.com.

About Northwestern University

Northwestern University is a comprehensive research university, established in 1851, that is deeply interdisciplinary across multiple schools and units. Its rigorous yet empathetic academic environment provides a robust mixture of theory and practice, with an emphasis on top-tier research, new knowledge, creative expression, and practical application. Northwestern Medicine is the shared strategic vision of Northwestern Memorial HealthCare (NMHC) and Northwestern University Feinberg School of Medicine to transform the future of healthcare and become a premier integrated academic health system. Each day, 33,700 clinical and administrative staff, medical and science faculty, and medical students come together with a shared commitment to superior quality, academic excellence, scientific discovery and patient safety.

Forward-Looking Statements

Some of the statements in this press release may be forward-looking statements that involve risks and uncertainties inherent in research and development. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. Such forward-looking statements include the expectations, plans, and prospects for the Company, including potential clinical successes, the potential impact of COVID-19 on our operations, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. No forward-looking statement can be guaranteed. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control. Calidi Biotherapeutics does not make any representation or warranty, express or implied, as to the completeness or updated status of such statements.

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