Dispatch Bio Doses First Patient in Phase 1 Trial of DISP-10, a Novel Synthetic-Antigen CAR T Immunotherapy for Advanced GI Cancers, Secures FDA Fast Track Designation
核心洞察
Dispatch Bio (搜索) announced the first patient has been dosed in a Phase 1 trial evaluating DISP-10 (搜索) in adults with advanced gastrointestinal cancers including colorectal, gastric, esophageal, and gastroesophageal adenocarcinomas.
DISP-10 (搜索) combines a tumor-specific virus (DV-10 (搜索)) that paints a synthetic BCMA (搜索) antigen onto tumor cells with Bristol Myers Squibb (搜索)'s approved BCMA-directed CAR T therapy idecabtagene vicleucel (ide-cel).
The U.S. FDA granted Fast Track designation to DISP-10 (搜索) for advanced GI cancers, underscoring the significant unmet need in solid tumor immunotherapy.
Dispatch Bio (搜索), a Philadelphia and San Francisco-based biotech company, announced that the first participant has been dosed in a Phase 1 clinical trial evaluating DISP-10 (搜索), a novel investigational immunotherapy for advanced gastrointestinal (GI) cancers. The participant received both components of DISP-10 — the tumor-specific virus DV-10 (搜索) and the BCMA (搜索)-directed CAR T therapy idecabtagene vicleucel (ide-cel) — and completed the protocol-defined dose-limiting toxicity (DLT) evaluation period. Concurrently, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DISP-10 for the treatment of advanced GI cancers.
The trial marks the clinical debut of Dispatch Bio (搜索)'s first-in-class Flare platform, designed to address key barriers that have historically limited the efficacy of immunotherapy in solid tumors.
A Two-Component Approach to Solid Tumor Immunotherapy
DISP-10 (搜索) represents a novel strategy that pairs two distinct therapeutic modalities. The first component, DV-10 (搜索), is a tumor-specific virus engineered to deliver a modified B cell maturation antigen (dBCMA) along with the cytokines IL-18 and CXCL9 directly to tumor cells. This mechanism effectively "paints" a synthetic antigen onto the tumor surface, remodels the tumor microenvironment to support T cell function, and enhances T cell trafficking into tumors.
The second component is ide-cel, Bristol Myers Squibb (搜索)'s BCMA (搜索)-directed CAR T cell therapy currently approved in the U.S. for multiple myeloma. By engineering tumor cells to express a synthetic BCMA target, Dispatch aims to redirect ide-cel's established cytotoxic activity against GI malignancies — a setting where CAR T therapy has not been previously approved or studied.
"Initiating this trial represents a meaningful step forward for patients with advanced GI cancers, reinforced by the FDA's Fast Track designation for DISP-10 (搜索)," said Mauro Avanzi, M.D., Ph.D., Chief Medical Officer of Dispatch. "We look forward to advancing this study as we work to overcome the longstanding limitations of treating solid tumors with immunotherapy, including lack of a safe and homogeneously expressed target antigen, a narrow therapeutic window, and an inhibitory tumor microenvironment. DISP-10 aims to address these barriers with our novel approach."
Trial Design and Patient Population
The Phase 1 trial (NCT07544589) is a multicenter, open-label, first-in-human study designed to evaluate the safety, tolerability, and activity of DISP-10 (搜索). The study will enroll up to 66 adult participants with advanced GI cancers, including colorectal cancer (搜索), gastric adenocarcinoma (搜索), esophageal adenocarcinoma (搜索), and gastroesophageal adenocarcinoma (搜索).
The company reported that the first participant received both DV-10 (搜索) and ide-cel and completed the protocol-defined DLT evaluation period, though no safety or efficacy data from that observation were disclosed.
Addressing a Growing Unmet Need
The clinical development of DISP-10 (搜索) comes at a time of increasing urgency in GI oncology. Colorectal cancer (搜索) is currently the leading cause of cancer death among people under age 50, according to the company. By leveraging components with significant clinical experience — including an already-approved CAR T therapy — Dispatch aims to proceed rapidly through clinical development and ultimately bring a major advancement to patients suffering from advanced GI cancers.
The Fast Track designation from the FDA is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need, potentially enabling more frequent interactions with the agency and eligibility for accelerated approval and priority review.