Dispatch Bio's 'Paint and Destroy' Cancer Therapy Gets FDA Green Light

PHILADELPHIA & SAN FRANCISCO – January 12, 2026 – The U.S. Food and Drug Administration (FDA) has given the go-ahead for a novel cancer therapy that effectively "paints" solid tumors with a synthetic target, priming them for destruction by a powerful, repurposed immunotherapy. Dispatch Bio announced today that its Investigational New Drug (IND) application for DISP-10 has been cleared, paving the way for a first-in-human Phase 1 clinical trial for patients with solid tumors.

The investigational therapy represents a pioneering two-pronged attack designed to overcome the most significant hurdles that have limited the success of cutting-edge immunotherapies in solid cancers. The initial study will focus on patients with gastrointestinal cancers, an area with substantial unmet medical needs.

"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, M.D., Ph.D., Chief Medical Officer of Dispatch. "Because DISP-10 was designed with broad applicability in mind, we plan to leverage early clinical insights to expand into multiple additional solid tumor indications following clinical proof of concept."

A Novel Strategy to Outsmart Solid Tumors

For years, the revolutionary potential of CAR T-cell therapy—which involves engineering a patient's own T-cells to fight cancer—has been largely confined to blood cancers like leukemia and multiple myeloma. Solid tumors, which constitute about 90% of all cancers, have remained a formidable fortress due to two primary challenges: the lack of unique and universal targets on cancer cells and the creation of a hostile, immunosuppressive tumor microenvironment (TME) that shields the tumor from immune attack.

Dispatch Bio's first-in-class Flare platform, the engine behind DISP-10, was engineered to systematically dismantle these defenses. The therapy consists of two components administered sequentially.

First, patients receive DV-10, a tumor-selective virus. This engineered virus is designed to infect cancer cells and execute two critical functions. It "paints" the surface of tumor cells with a synthetic antigen, a modified B-cell maturation antigen (dBCMA), which does not naturally appear on solid tumors. This effectively creates a uniform, artificial target for the immune system to lock onto.

Simultaneously, the DV-10 virus acts as a microenvironment remodeler. It produces and releases two powerful immune-signaling molecules, IL-18 and CXCL-9, directly into the tumor. IL-18 is a cytokine known to stimulate T-cell activity, while CXCL-9 is a chemokine that acts like a beacon, recruiting T-cells and other immune warriors into the previously "cold" and inaccessible tumor, transforming it into a "hot" battleground ripe for an immune assault.

Repurposing a Proven Weapon for a New War

Once the tumor has been painted and the battlefield prepared, the second component of DISP-10 is deployed: idecabtagene vicleucel, or ide-cel. Marketed by Bristol Myers Squibb as Abecma, ide-cel is an FDA-approved autologous CAR T-cell therapy that has demonstrated remarkable success in treating relapsed or refractory multiple myeloma. These CAR T-cells are specifically engineered to recognize and kill cells expressing the BCMA protein.

In its approved use, ide-cel targets the natural BCMA on myeloma cells. In Dispatch Bio's strategy, these same powerful CAR T-cells are redirected to attack the synthetic dBCMA antigen that the DV-10 virus has just painted onto the solid tumor cells. This clever approach leverages the proven efficacy and known safety profile of an existing therapy, aiming to apply its cancer-killing power to a vast new category of diseases.

The initial clinical evaluation in gastrointestinal cancers is particularly significant. Many of these cancers, such as pancreatic cancer and microsatellite-stable colorectal cancer, are notoriously resistant to current immunotherapies like checkpoint inhibitors, leaving patients with few effective options. By creating its own target and actively recruiting an immune response, DISP-10 offers a potential paradigm shift for these difficult-to-treat malignancies.

From Promising Preclinical Data to Patient Bedside

The FDA's decision to clear the IND application was supported by a robust package of preclinical data, including findings presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting. In numerous in vitro and in vivo models, Dispatch Bio demonstrated that its Flare platform could achieve strong and consistent tumor labeling across multiple types of epithelial tumors.

The studies showed that not only did the virus effectively paint its target, but it also amplified itself within the tumor, spreading the synthetic antigen to neighboring cancer cells. This triggered potent anti-tumor responses and led to tumor cell clearance, all while showing no activity in healthy cells, underscoring the approach's specificity and potential for a favorable safety profile.

The initiation of the Phase 1 study marks a critical transition for Dispatch Bio from a preclinical research company to a clinical-stage entity. This first trial will be crucial for establishing the safety and optimal dose of DISP-10 in humans. Researchers will also closely monitor for early signals of therapeutic activity, such as tumor shrinkage or biomarkers indicating a successful immune response. If the approach proves successful, it could validate the entire Flare platform and its potential to serve as a universal treatment strategy applicable across a wide spectrum of solid tumors.