PHILADELPHIA, PA & SAN FRANCISCO, CA — Dispatch Bio said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for DISP-10, allowing the company to initiate a Phase 1 clinical trial evaluating a novel immunotherapy approach in patients with solid tumors.
The company said patient enrollment is expected to begin in the coming months.
DISP-10 is an investigational, two-part treatment designed to address limitations that have constrained the effectiveness of immunotherapy in solid tumors. The first component, known as DV-10, is a tumor-selective virus engineered to deliver a modified B-cell maturation antigen along with the immune signaling molecules IL-18 and CXCL-9. The virus is intended to create a synthetic target on tumor cells, modify the tumor microenvironment, and improve immune cell infiltration.
The second component is idecabtagene vicleucel, or ide-cel, a BCMA-directed autologous CAR T-cell therapy developed by Bristol Myers Squibb. Under the planned study protocol, patients will receive DV-10 followed by ide-cel.
Dispatch said the initial Phase 1 study will focus on gastrointestinal cancers, an area with limited treatment options. The company said it plans to use early clinical data to inform potential expansion into additional solid tumor indications.
“FDA clearance of the IND for DISP-10 represents an important milestone for Dispatch as we advance our first clinical program for patients with solid tumors of epithelial origin,” said Mauro Avanzi, the company’s chief medical officer.
The program is based on Dispatch’s Flare platform, which the company describes as a first-in-class system designed to overcome immune resistance and poor T-cell activity commonly seen in solid tumors.
Dispatch previously presented preclinical data supporting DV-10 and the Flare platform at the 2025 annual meeting of the Society for Immunotherapy of Cancer. The company said those findings demonstrated tumor selectivity, immune activation, and safety profiles that supported advancement into clinical testing.
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