Press Release

Calidi Biotherapeutics Announces Two Abstracts Accepted for Presentation at AACR 2020 Virtual Annual Meeting II

Calidi Biotherapeutics

SAN DIEGO, CA - (BUSINESS WIRE) - Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of oncolytic virus-based immunotherapies for cancer, announced today that data from clinical studies on their oncolytic agent, CAL1 vaccinia virus, and stem cell delivery system will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting II, which will be held in virtual format June 22 through June 24, 2020, due to COVID-19 concerns.

Calidi’s respective e-poster presentations will highlight findings from translational research on the potential use of the CAL1 vaccinia virus, a version of the ACAM2000 smallpox vaccine delivered via an allogeneic adipose-derived mesenchymal stem cell (MSC) system, as well as insights from clinical trials analyzing the potential use of Calidi’s autologous SVF delivery platform to modulate innate and adaptive immunity in patients with solid tumors and hematological malignancies.

CAL1 was evaluated for abilities to safely replicate and selectively kill cancer cells, to be genetically modified (generating next generation armed-oncolytic viruses) without affecting its natural tumor selectivity, and to determine if its anti-tumor effects can be enhanced and protected from inactivation by immune system response when delivered via Calidi’s off-the-shelf MSC platform. The modified vaccinia virus strain demonstrated efficacy as an oncolytic agent, exhibiting heightened therapeutic capacity when loaded into adipose-derived mesenchymal stem cells to create Calidi’s SuperNova (SNV) product.

Calidi’s study on the immunomodulatory potential of vaccinia virus delivered by autologous SVF-derived cells expanded on their recent first-in-human Phase I clinical trial, which confirmed the safety and feasibility of their approach for improving virus delivery and tumor targeting. This study establishes a timeline of treatment-related immunological changes, identifies potential immunological correlations with continued amplified oncolytic therapy, and provides insights into the role of interpatient immunological variability and future oncolytic virotherapy evaluation.

Both abstracts indicate significant advantages and fundamental rationale for the development of vehicles like Calidi’s cell-based delivery platform (https://calidibio.com/our-science/), designed to protect and potentiate oncolytic viruses by circumventing innate and adaptive immune barriers, resulting in enhanced oncolytic virotherapy.

AACR presentation details are as follows:

Abstract 6542: CAL1 vaccinia virus as oncolytic agent and potential use of cell-based platform to enhance its therapeutic effects

Date: June 22, 2020, from 9:00 AM to 6:00 PM

Abstract 4473: Evaluation of the potential of oncolytic vaccinia virus delivered by autologous SVF to modulate innate and adaptive immunity in patients with diverse solid and hematological malignancies

Date: June 22, 2020, from 9:00 AM to 6:00 PM

About Calidi Biotherapeutics

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery of oncolytic viruses 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 San Diego, California. For more information, please visit www.calidibio.com.

About the AACR Virtual Annual Meetings

The AACR Annual Meeting program covers the latest discoveries across the spectrum of cancer research—from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy—and highlights the work of the best minds in research and medicine from institutions all over the world. Please visit aacr.org for additional information.

On April 6, due to the rapid escalation of the COVID-19 pandemic, the AACR Board of Directors made the decision not to move forward with an in-person Annual Meeting in August, and instead to present segments of the meeting program in two AACR Virtual Annual Meetings. The 2020 AACR Virtual Annual Meeting I took place from April 27 to April 28, 2020.

Forward Looking Statement

Some of the statements in this press release may be forward-looking statements that involve risks and uncertainties inherent in research and development. Such forward-looking statements include the 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. 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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