Viridion Therapeutics develops CARG‑2020, a first‑in‑class replicating mRNA immunotherapy built on the AVIDIO™ self‑amplifying RNA virus‑like vesicle platform. The therapy delivers multiple immune signals to reprogram the tumor microenvironment, converting cold tumors into hot, immune‑responsive ones and generating durable anti‑tumor immune memory to prevent recurrence. Pre‑IND discussions with the FDA are complete and the company is preparing for a Phase I/Ib clinical study in solid tumors.
Funding
Funding not disclosed
Founders
Product
Problem
Tumor recurrence is the leading cause of mortality in patients with solid cancers, and existing immunotherapies typically target a single immune pathway, leaving residual disease unchecked. Persistent immunosuppressive mechanisms such as M2 macrophages, myeloid‑derived suppressor cells, cytokine imbalance, and PD‑L1–mediated escape enable cancer cells to re‑emerge after initial treatment.
Solution
Viridion’s lead candidate, CARG‑2020, is a replicating mRNA immunotherapy built on the AVIDIO™ self‑amplifying virus‑like vesicle (VLV) platform. The single construct co‑expresses IL‑12, a dominant‑negative IL‑17RA, and shRNA targeting PD‑L1, delivering three complementary immune‑modulating signals directly to the tumor site. Localized intratumoral or intraperitoneal administration yields high transgene expression without genomic integration, reprogramming the tumor microenvironment from “cold” to “hot.” This multi‑mechanism approach activates innate and adaptive immunity, reduces pro‑tumor inflammation, and blocks checkpoint‑mediated T‑cell exhaustion, generating durable anti‑tumor immune memory aimed at preventing recurrence. Pre‑IND discussions with the FDA are complete, and the program is preparing for Phase I/Ib trials in recurrent platinum‑resistant ovarian cancer.
Target Audience
Primary customers are oncology drug developers and clinical research programs focused on solid‑tumor indications with high recurrence risk, particularly in recurrent ovarian cancer, as well as academic and biotech partners seeking a multi‑mechanism immunotherapy platform.
Features
- AVIDIO™ self‑amplifying VLV platform enables high‑level, transient expression of multiple therapeutic genes from a single localized dose
- Single construct delivers IL‑12 (immune activation), dominant‑negative IL‑17RA (inflammation neutralization), and PD‑L1 shRNA (checkpoint silencing) simultaneously
- Built‑in amplification drives robust transgene expression at the injection site while minimizing systemic exposure and toxicity
- Intratumoral/intraperitoneal delivery concentrates activity in the tumor microenvironment, promoting M1 macrophage polarization, reducing MDSCs, and increasing CD8⁺ T‑cell infiltration
- Each component has independent clinical precedent, de‑risking the combination therapy
- Non‑pathogenic, non‑integrating RNA vesicle ensures transient expression and favorable safety profile