Calidi Biotherapeutics Taps TransferAI’s Sofie AI to Accelerate CLD-401 IND Filing by Year-End
Calidi Biotherapeutics partnered with TransferAI to leverage its Sofie agentic AI platform to streamline the IND submission for CLD-401, its lead RedTail-based virotherapy expressing IL-15 superagonist. IND-enabling studies are underway with an expected filing by year-end to support phase I trials in non-small cell lung and head and neck cancers.
1. Strategic Partnership with TransferAI
Calidi Biotherapeutics has entered a collaboration with TransferAI to integrate the Sofie agentic AI platform into its regulatory workflows. The partnership aims to enhance precision, traceability and efficiency in drafting, cross-referencing and reviewing complex IND submission materials, allowing Calidi’s teams to focus on scientific and manufacturing execution.
2. CLD-401 Candidate and RedTail Platform
CLD-401 is the lead candidate from Calidi’s proprietary RedTail platform, engineered to systemically deliver an enveloped oncolytic virus expressing high levels of IL-15 superagonist. This design selectively targets tumors, remodels the tumor microenvironment and activates CD8 T-cells, gamma delta T-cells and NK cells for enhanced therapeutic effect.
3. IND Timeline and Development Impact
IND-enabling studies for CLD-401 are in progress, with an IND filing targeted by year-end to support phase I evaluation in non-small cell lung, head and neck cancers. Accelerated regulatory workflows could shorten development timelines and de-risk early clinical milestones based on the team’s prior IND submission experience.