Calidi receives FDA Fast Track designation for CLD-201

Calidi (CLDI) Biotherapeutics announced that it received Fast Track designation from the U.S. Food and Drug Administration, FDA, for CLD-201, the company’s allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma. Guy Travis Clifton, M.D., Chief Medical Officer of Calidi commented, “FDA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the unmet medical need in sarcoma and provides scientific and regulatory validation of CLD-201. We believe CLD-201 has the potential to provide durable and transformational treatment to patients with sarcoma as well as patients with other advanced tumor types. We want to thank the FDA for its support and partnership and look forward to continued collaboration with the agency.”