Business
Calidi Biotherapeutics Presents its Innovative and Scalable Manufacturing Process for CLD-401 at the 9th Annual Bioprocessing Summit; FDA Feedback Support Company’s Approach to Manufacturing
SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today presented on its proprietary manufacturing process for CLD-401, the Company’s first lead candidate from its RedTail platform, at the BioProcessing Summit in Barcelona. RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumor cells, remodel th
About this update from Calidi Biotherapeutics, Inc.
[{"type":"image","alt":"Calidi Biotherapeutics, Inc","displaySize":"","headline":null,"caption":"Calidi Biotherapeutics, Inc","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":93,"url":"https://media.zenfs.com/en/globenewswire.com/8983e19176ab43568fb63e4ece5ad7a1"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/TVVsA9n31LT1YQqkVdlDAw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/8983e19176ab43568fb63e4ece5ad7a1","width":300,"height":93}},"lazy":false},{"type":"text","content":"SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today presented on its proprietary manufacturing process for CLD-401, the Company’s first lead candidate from its RedTail platform, at the BioProcessing Summit in Barcelona.","length":381,"tagName":"p"},{"type":"text","content":"RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumor cells, remodel the tumor microenvironment (TME), and enable high-level expression of therapeutic genetics at the tumor. CLD-401 is designed to reach metastatic sites, replicate only in tumor cells, and express high levels of IL-15 superagonist (IL-15 SA), a known T-cell and Natural Killer cell activator, in the TME.","length":418,"tagName":"p"},{"type":"text","content":"At the meeting, Calidi outlined key aspects of its manufacturing system designed to support scalable and high-yield manufacturing of CLD-401. This process, developed in-house, maintains the integrity of the CD55 over-expressing envelope unique to the Company’s RedTail virus that allows for systemic delivery by preventing immune recognition.","length":342,"tagName":"p"},{"type":"text","content":"Calidi has interacted with the FDA around the Company’s manufacturing and analytical approaches through its Type D meeting request process. The feedback it has received from the agency supports the use of this process for the clinical development of CLD-401.","length":258,"tagName":"p"},{"type":"text","content":"“The process discussed today highlights key scalability properties of the manufacturing system we have developed for the RedTail platform and CLD-401” said Antonio F. Santidrian, PhD, Chief Scientific Of...