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

On March 24, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported a partnership with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in Australia. The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401 in Australia. In parallel, the Company will pursue an IND filing with the FDA in 2026.

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CLD-401 is a genetically modified form of vaccinia virus that is systemically delivered, replicates only in tumor cells, and expresses high levels of IL-15 superagonist (IL-15 SA), an activator of innate and adaptive immune response, in the tumor microenvironment. The planned phase I will investigate the safety, pharmacodynamics, and efficacy of CLD-401 given as monotherapy in patients with solid tumors that have exhausted all other therapeutic options.

"We believe CLD-401 represents a unique mechanism of action in oncology," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We are excited to work with Avance Clinical to initiate clinical studies as quickly as possible and bring this potential treatment option to patients whose disease is resistant to current therapies."

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, MAR 24, 2026, View Source [SID1234663886])