FAQ on Calidi Biotherapeutics Inc. Receiving FDA Fast Track Designation for CLD-201 in Soft Tissue Sarcoma

What is CLD-201 and what does it treat?

CLD-201, also known as SuperNova, is an allogeneic adipose stem-cell loaded oncolytic virus developed by Calidi Biotherapeutics for treating soft tissue sarcoma, among other cancers like triple-negative breast cancer and head and neck squamous cell carcinoma.

Why is the FDA Fast Track designation significant for CLD-201?

The FDA Fast Track designation is significant because it provides opportunities for expedited development of CLD-201, including priority review and accelerated approval, potentially bringing the treatment to patients faster.

How does CLD-201 work in treating cancer?

CLD-201 utilizes allogeneic stem cells capable of carrying payloads of oncolytic viruses to target and fight cancer cells, enhancing efficacy and improving patient safety by protecting, amplifying, and potentiating the oncolytic viruses.

Who is behind the development of CLD-201?

Calidi Biotherapeutics, a clinical-stage immuno-oncology company headquartered in San Diego, California, is developing CLD-201, with Guy Travis Clifton, M.D., serving as the Chief Medical Officer.

When will CLD-201 enter clinical trials?

Following IND clearance in April, CLD-201 is set to enter a Phase 1 trial to evaluate its safety and efficacy in treating sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.

Where can I find more information about Calidi Biotherapeutics and CLD-201?

More information can be found on Calidi Biotherapeutics’ website at www.calidibio.com or in the company’s newsroom at https://ibn.fm/CLDI.

What are the potential benefits of CLD-201 for cancer patients?

CLD-201 has the potential to deliver durable, transformational treatment for patients with advanced tumors, offering a novel approach to fighting cancer with enhanced efficacy and improved safety.

How does Calidi Biotherapeutics’ approach compare to traditional cancer treatments?

Calidi Biotherapeutics’ approach uses stem cell-based platforms to deliver oncolytic viruses directly to cancer cells, a method designed to be more targeted and potentially more effective than traditional treatments, with fewer side effects.