Calidi Biotherapeutics Secures Avance Clinical Partnership to Launch 2026 CLD-401 Phase I Trial
Calidi Biotherapeutics partnered with Avance Clinical to secure Australian approval and initiate a first-in-human CLD-401 trial while pursuing an FDA IND in 2026. CLD-401, a vaccinia-based oncolytic virus expressing IL-15 superagonist, will enter phase I to assess safety, pharmacodynamics and efficacy in advanced solid tumors.
1. Partnership with Avance Clinical
Calidi Biotherapeutics has entered into a collaboration with Avance Clinical, a full-service CRO experienced in Australian regulatory submissions, to accelerate approval processes and rapidly initiate the first-in-human trial of CLD-401 in Australia.
2. CLD-401 Oncolytic Therapy Profile
CLD-401 is a systemically delivered, genetically engineered vaccinia virus designed to replicate exclusively in tumor cells and produce IL-15 superagonist at high levels to stimulate both innate and adaptive immune responses within the tumor microenvironment.
3. Phase I Trial Planning and IND Filing
The upcoming Phase I study will evaluate safety, pharmacodynamics and preliminary efficacy of CLD-401 as monotherapy in patients with advanced solid tumors who have exhausted standard treatments, while Calidi prepares an IND submission to the FDA slated for 2026.
4. Redtail Platform and Pipeline Expansion
This lead candidate emerges from Calidi’s proprietary Redtail platform, which shields oncolytic viruses from immune clearance for systemic delivery; the company is concurrently advancing additional Redtail-based programs and seeking further strategic partnerships.