Calidi Biotherapeutics, Inc. (CLDI), a biotechnology company, on Tuesday announced a partnership with Avance Clinical, a contract research organisation (CRO) with experience in obtaining regulatory approvals and initiating clinical trials in Australia, to rapidly initiate a first-in-human clinical trial for its investigational candidate, CLD-401.
Following the news, CLDI is up 3.65% at $0.30 in the pre-market.
In parallel, Calidi will pursue an IND filing for CLD-401 with the FDA in 2026.
CLD-401 is a genetically modified vaccinia virus, and Calidi's lead candidate from the Redtail platform, currently in IND-enabling studies and targets non-small cell lung cancer, head and neck cancer, and other tumour types with high unmet medical need.
The planned phase I trial will investigate the safety, pharmacodynamics, and efficacy of CLD-401 as monotherapy in patients with solid tumours who have exhausted all other therapeutic options.
The company's proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites.
CLDI has traded between $0.28 and $19.20 in the last year. The stock closed Monday's trade at $0.29, up 4.24%
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