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

LA JOLLA, Calif.–(BUSINESS WIRE)–#adenovirus–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

Calidi Biotherapeutics cautions you that this press release contains forward-looking statements. 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. Forward-looking statements involve risks and uncertainties, including, without limitation, research and development, expectations, plans, and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares, risks related to the costs to meet the Company’s commitments to fund clinical trials, the potential impact of COVID-19 on our or any of our partner’s or collaborator’s financial and operational results, risks inherent in the development and/or commercialization of potential therapies or products, uncertainty in the results of clinical trials or regulatory approvals, our reliance and ability to procure manufacturing capacity and manufacturing services from third-party manufacturers required for our products, the need and ability to obtain future capital and the maintenance of intellectual property rights in all applicable jurisdictions. No forward-looking statement can be guaranteed. The statements made by the Company are based upon management’s current expectations. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Calidi Biotherapeutics. 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. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Calidi Biotherapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts

Press/Investor Contact: Stephen Thesing

Chief Admin. Officer & Investor Relations

Telephone: +1-858-794-9603

[email protected]

Marla Paul

Northwestern University Senior Health Sciences Editor

Telephone: +1-312-503-8928

[email protected]