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# Calidi Bio Gets Fast Track for Sarcoma Therapy
- URL: https://www.fdaweb.com/calidi-bio-gets-fast-track-for-sarcoma-therapy/
- Published: 2025-07-30T12:00:00.000Z
- Updated: 2026-09-14T15:17:49.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159600

FDA has granted Calidi Biotherapeutics fast-track status for CLD-201, an allogeneic stem-cell-loaded oncolytic virus being developed to treat soft tissue sarcoma. The therapy uses adipose-derived mesenchymal stem cells loaded with an oncolytic vaccinia virus to deliver therapy directly to tumor sites, according to the company. This strategy is intended to shield the virus from the immune system, enhance its replication, and amplify immune activation, an approach that has demonstrated promising results in preclinical studies, it says.

Calidi says it is planning a Phase 1 trial to evaluate the safety, tolerability, and preliminary efficacy of CLD-201 in patients with soft tissue sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.