PHILADELPHIA, PA — Dispatch Bio has dosed the first patient in a Phase 1 trial of DISP-10 for advanced gastrointestinal cancers, moving its experimental solid-tumor immunotherapy into human testing as the treatment also secured Fast Track designation from the U.S. Food and Drug Administration.
The first participant received both components of DISP-10 and completed the study’s protocol-defined dose-limiting toxicity evaluation period, the Philadelphia biotechnology company reported. The trial includes adults with advanced colorectal cancer, gastric adenocarcinoma, esophageal adenocarcinoma and gastroesophageal adenocarcinoma.
The first-in-human, multicenter, open-label study is evaluating DISP-10’s safety, tolerability and activity. The company did not report efficacy results from the first patient.
DISP-10 combines Dispatch’s experimental tumor-specific virus, DV-10, with idecabtagene vicleucel, or ide-cel, a BCMA-directed CAR T-cell therapy from Bristol Myers Squibb. Ide-cel is approved in the U.S. but has not been studied or approved for use in solid tumors, according to Dispatch.
The approach is designed to overcome barriers that have limited the effectiveness of immunotherapies in solid tumors. DV-10 is engineered to deliver a modified B-cell maturation antigen, or dBCMA, to tumor cells while also delivering IL-18 and CXCL9.
That process is intended to create a synthetic target on tumor cells, alter the tumor microenvironment to support T-cell activity and improve T-cell movement into tumors. Ide-cel is then intended to recognize the BCMA target.
Dispatch is developing the treatment through its Flare platform, which seeks to extend cell-based immunotherapy to solid tumors by creating targets rather than relying on antigens naturally expressed by cancer cells.
The FDA’s Fast Track designation gives DISP-10 access to mechanisms intended to accelerate development and regulatory review of therapies targeting serious conditions with unmet medical needs. Those can include more frequent interactions with the agency and, if applicable, rolling review of portions of a future regulatory application.
Mauro Avanzi, Dispatch’s chief medical officer, identified the lack of a safely and consistently expressed target antigen, a narrow therapeutic window and an inhibitory tumor microenvironment as longstanding obstacles to using immunotherapy against solid tumors.
“DISP-10 aims to address these barriers with our novel approach,” Avanzi stated.
Marwan Fakih, division chief of GI medical oncology and deputy director of City of Hope Comprehensive Cancer Center, pointed to limited treatment options for patients with advanced gastrointestinal cancers as the rationale for testing additional approaches.
“There is a clear need for new approaches,” Fakih stated, adding that the study will test whether the strategy can expand the potential use of immunotherapy for these patients.
DISP-10 remains investigational, and the Phase 1 study represents an early stage of clinical development intended primarily to establish its safety and tolerability before its therapeutic potential can be determined.
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