GlobeNewswire·Mar 24, 2026, 8:00 AM ET

Calidi Biotherapeutics Announces Partnership with Avance Clinical to Facilitate Australian Regulatory Approval and Accelerate Initiation of CLD-401 Clinical Trials

Calidi Biotherapeutics (NYSE: CLDI) announced a partnership with Avance Clinical to rapidly initiate a first-in-human clinical trial for CLD-401 in Australia.
The company plans to file an IND with the FDA in 2026 while simultaneously pursuing the Australian trial.
CLD-401 is a genetically modified vaccinia virus that replicates only in tumor cells \& expresses high levels of IL-15 superagonist to activate immune responses.
The planned Phase I trial will evaluate the safety, pharmacodynamics, \& efficacy of CLD-401 as monotherapy for patients with solid tumors who have exhausted other options.
CLD-401 is the lead candidate from Calidi's RedTail platform, which currently undergoes IND-enabling studies.
The RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery to metastatic sites while shielding the virus from immune clearance.
CLD-401 targets non-small cell lung cancer, head and neck cancer, \& other tumor types with high unmet medical need.
Calidi is expanding the RedTail platform's functionality \& pursuing strategic partnerships to accelerate clinical development.