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

Core Viewpoint - Calidi Biotherapeutics is advancing its proprietary RedTail platform and its lead candidate CLD-401, which targets metastatic tumors and aims to enhance the delivery of genetic medicines [1][6]. Group 1: Company Overview - Calidi Biotherapeutics is a biotechnology company focused on developing targeted therapies for delivering genetic medicines to distal sites of disease [6]. - The RedTail platform utilizes an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites, shielding the virus from immune clearance [6]. Group 2: Product Development - CLD-401 is the first lead candidate from the RedTail platform, currently in IND-enabling studies, targeting non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need [7]. - The company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026 [5]. Group 3: Manufacturing and FDA Interaction - Calidi presented its proprietary manufacturing process for CLD-401 at the BioProcessing Summit, emphasizing its scalability and high-yield capabilities [3]. - The manufacturing process maintains the integrity of the CD55 over-expressing envelope, which is crucial for systemic delivery and preventing immune recognition [3]. - Feedback from the FDA supports the company's manufacturing and analytical approaches, indicating a positive outlook for clinical development [4][5]. Group 4: Strategic Partnerships and Future Plans - The company is actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform [5]. - Calidi continues to expand the functionality of the RedTail platform, including incorporating T-cell engagers in solid tumors [7].