Quote data as of 5:17 AM ET
Calidi Biotherapeutics, Inc., a clinical stage immuno-oncology company, engages in developing immunotherapies for the treatment of cancer. It engages in advancing a potent allogeneic stem cell capable of carrying an anti-tumor payload for use in multiple oncology indications, including high-grade gliomas and solid tumors. The company's cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Its pipeline of products candidates in the clinic includes NeuroNova that are allogeneic neural stem cells loaded with an oncolytic adenovirus for the treatment of high-grade gliomas; and SuperNova, which are allogeneic adipose-derived mesenchymal stem cells loaded with tumor-selective CAL1 oncolytic vaccinia virus for the treatment of advanced metastatic solid tumors. The company was founded in 2014 and is based in San Diego, California.
Calidi Biotherapeutics received positive pre-IND feedback from the FDA for its lead candidate CLD-401, agreeing on the IND-enabling preclinical plans and clinical strategy.
The company is targeting a regulatory submission by year-end 2026 and plans to initiate the first-in-human clinical trial in early 2027.
This milestone validates the proprietary RedTail platform, which focuses on systemic delivery of oncolytic viruses for metastatic sites.