BioMedNewsBreaks – Calidi Biotherapeutics Inc. (NYSE American: CLDI) Receives FDA Fast Track Designation for CLD-201 in Soft Tissue Sarcoma

Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotechnology company developing targeted genetic medicine delivery therapies, announced that the U.S. Food and Drug Administration granted Fast Track designation to CLD-201 (SuperNova), its allogeneic adipose stem-cell loaded oncolytic virus for treating soft tissue sarcoma. The designation provides opportunities for expedited development, including priority review and accelerated approval. CLD-201, which received IND clearance in April, will enter a Phase 1 trial evaluating safety and efficacy in sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma. Chief Medical Officer Guy Travis Clifton, M.D., said the milestone validates CLD-201’s potential to deliver durable, transformational treatment for patients with advanced tumors.

To view the full press release, visit: https://ibn.fm/yqrWh

About Calidi Biotherapeutics

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, visit the company’s website at 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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