Calidi Biotherapeutics Inc. (NYSE American: CLDI) Pioneers Systemic Virotherapy with RTNova Platform

• Calidi’s RTNova platform leverages engineered enveloped vaccinia viruses designed for systemic delivery.
• Calidi’s groundbreaking virotherapy holds “immense promise in revolutionizing the treatment landscape for cancer patients with advanced solid tumors,” says CEO.

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage biotechnology company at the forefront of developing innovative immunotherapies for cancer treatment. Most recently, the company has captured the spotlight for the development of its proprietary systemic platform, RTNova (https://ibn.fm/Z4pM3). The platform represents a significant advancement in systemic virotherapy, particularly in the utilization of enveloped virotherapies to target metastatic tumors across the body.

Antitumor virotherapy employs viruses that selectively infect and destroy cancer cells while sparing normal tissues. However, a significant challenge in the administration of these viruses is their rapid neutralization by the immune system, limiting their therapeutic efficacy.

To address this challenge, Calidi designed an innovative vaccinia virus strain enveloped with a human cell membrane (extracellular enveloped virus or EEV), providing protection in the bloodstream while targeting distant tumors (https://ibn.fm/c5fWc). Once inside the tumor, virotherapies are designed to selectively replicate and destroy tumor cells. This process activates an immune response and helps train the immune system to recognize and target future cancer cells. Additionally, the platform can target distant tumors and then act as a viral vector to deliver specific gene therapies to tumor sites.

“Calidi’s groundbreaking systemic enveloped virotherapy holds immense promise in revolutionizing the treatment landscape for cancer patients with lung cancer and metastatic advanced solid tumors,” said Allan Camaisa, Calidi Biotherapeutics CEO and board chair. “By providing protection to the virus during administration, our antitumor virotherapy is able to reach and attack the tumor sites and then activate the immune system. This is the first antitumor virotherapy with systemic administration that shows the potential for real efficacy in the clinic.”

Calidi’s innovative approach builds upon years of experience in using stem cells to protect antitumor viruses from neutralization by the patient’s immune system.

In addition to the RTNova platform, Calidi is advancing other clinical programs, including CLD-101 (NeuroNova) and CLD-201 (SuperNova), which are in various stages of development. These programs utilize stem cell–based platforms to deliver antitumor viruses, aiming to treat multiple oncology indications, such as high-grade gliomas and solid tumors. The company’s commitment to pioneering the future of cancer treatment is exemplified by its collaboration with City of Hope, where the fourth and final cohort of patients are being dosed in a phase 1 clinical trial evaluating neural stem cells carrying a tumor-killing adenovirus to treat recurrent high-grade glioma patients. Calidi also recently announced that Northwestern University commenced recruitment for a Phase 1b/2 trial using Calidi’s NeuroNova drug candidate in a multidosing strategy to treat newly diagnosed high-grade glioma.

Calidi Biotherapeutics’ dedication to harnessing the power of antitumor virotherapy positions the company as a leader in the field of cancer immunotherapy. By developing its systemic delivery mechanisms and leveraging the unique properties of enveloped viruses, Calidi is developing treatments that not only target tumors directly but also stimulate the body’s immune system to fight cancer more effectively. As its development programs progress, Calidi continues to make significant strides toward transforming the standard of care for patients with advanced and metastatic cancers.

For more information, visit www.CalidiBio.com.

NOTE TO INVESTORS: The latest news and updates relating to CLDI are available in the company’s newsroom at https://ibn.fm/CLDI

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