Onco-Summaries: Daily Oncology Updates at a Glance

29/07/2025

Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma (Ref)

The US FDA granted the Fast Track designation to Calidi Biotherapeutics' CLD-201 (SuperNova; allogeneic adipose stem-cell loaded oncolytic virus) for the treatment of soft tissue sarcoma.

• Guy Travis Clifton, CMO, Calidi: “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.” 

  
  

• FDA Investigational New Drug (IND) clearance for CLD-201 was announced in Apr'25

  
  

• The planned Phase 1 open-label, multicenter trial will evaluate the safety, tolerability and efficacy of CLD-201 in sarcoma, TNBC, and HNSCC