|
Dispatch Bio, a biotech company engineering a universal treatment across solid tumours leveraging its first-in-class Flare platform, announced the first participant has been dosed in a phase 1 clinical trial evaluating the safety and efficacy of DISP-10 in adult participants with advanced gastrointestinal (GI) cancers, including colorectal cancer, gastric adenocarcinoma, esophageal adenocarcinoma, and gastroesophageal adenocarcinoma. The participant was treated with both DV-10 and ide-cel components of DISP-10 and completed the protocol-defined dose-limiting toxicity (DLT) evaluation period. Additionally, DISP-10 has received Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of advanced GI cancers. DISP-10 is a novel, investigational therapy designed to address key challenges in the treatment of solid tumours.
“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,” 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 tumours with immunotherapy, including lack of a safe and homogeneously expressed target antigen, a narrow therapeutic window, and an inhibitory tumour microenvironment. DISP-10 aims to address these barriers with our novel approach.”
DISP-10 consists of two components. The first component, DV-10, is a tumour-specific virus engineered to deliver a modified B cell maturation antigen (dBCMA), along with IL-18 and CXCL9, to “paint” a synthetic antigen onto tumour cells, remodel the tumour microenvironment to support T cell function, and help enhance T cell trafficking into tumours. The second component is ide-cel, Bristol Myers Squibb’s BCMA-directed CAR T cell therapy approved in the US. By leveraging components with significant clinical experience, Dispatch aims to proceed rapidly through clinical development and ultimately bring a major advancement and option to patients suffering from advanced GI cancers, including colorectal cancer, which currently is the leading cause of cancer death among people under age 50.1
“Patients with advanced GI cancers can face a challenging prognosis, often measured in a handful of months with limited treatment options beyond chemotherapy,” said Marwan Fakih, M.D., division chief, GI Medical Oncology and Deputy Director, City of Hope Comprehensive Cancer Center. “There is a clear need for new approaches, and the initiation of this study with DISP-10 is an important step toward exploring a novel strategy that may expand the reach of immunotherapy treatments for patients.”
The first-in-human, phase 1, multicenter, open-label clinical study is designed to evaluate the safety, tolerability, and activity of DISP-10. The FDA’s Fast Track designation is intended to accelerate the development and review of investigational therapies that have demonstrated their potential to address serious conditions with unmet medical need. The designation enables more frequent engagement with the FDA and may allow for rolling review and other mechanisms to expedite the regulatory process.
Immunotherapies have had limited success in solid tumours due to the lack of tumour-specific targets and an immunosuppressive microenvironment. Dispatch’s first-in-class Flare platform addresses these barriers by systemically delivering a tumour-specific virus that paints a universal synthetic antigen (Flare) on tumour cells, enabling precise recognition by T cells, while reshaping the tumour microenvironment to support immune activity. At the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, Dispatch presented preclinical findings on DV-10 in combination with a clinically validated BCMA-directed CAR T. These data, presented alongside additional preclinical findings supporting the Flare platform, underscore the safety, specificity and therapeutic promise of this approach.
Gastrointestinal (GI) cancers, including colorectal, gastric, esophageal, and gastroesophageal cancers, collectively affect hundreds of thousands of people each year worldwide and represent one of the most significant unmet medical needs in oncology. Historically, GI cancers have accounted for one in four cancer cases diagnosed and one in three cancer deaths globally. In the advanced or metastatic setting, treatment options remain limited and prognosis is poor, underscoring the urgent need for novel therapeutic approaches.
Dispatch Bio was founded with a bold purpose: to help create a world where all cancer patients can be cured. To achieve this, the company is engineering a universal treatment across solid tumours, leveraging its first-in-class Flare platform.
|