DEM301 / DEM Biopharma - LARVOL DELTA

A Phase 1 Study of DEM301 in Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: DEM BioPharma, Inc.

First-in-human • New P1 trial • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

DEM301, a novel bifunctional ADC with potent immunomodulatory activity for potential use in difficult to treat colorectal malignancies (AACR 2026) - "DEM301 is a first-in-class bifunctional ADC with potent cytotoxic and immunomodulatory activity, resulting in robust anti-tumor responses in models of TOP-1 inhibitor resistance and MSS malignancies. Collectively, these preclinical data support further investigation of DEM301 in patients, including those with difficult-to-treat irinotecan-insensitive and/or MSS tumors."

ADC • Immunomodulating • Late-breaking abstract • Colon Cancer • Colorectal Cancer • Oncology • TOP1

Activity of DEM301, a novel anti-DEM-TXX antibody-drug conjugate for the treatment of gastrointestinal tumors. (ASCO-GI 2026) - "DEM301, a novel DEM-TXX-targeted ADC, demonstrated potent anti-tumor efficacy in preclinical models of GI tumors and a favorable safety profile in a humanized DEM-TXX mouse model, supporting advancement toward clinical development. DEM301 efficacy in xenograft tumor models. *Compared to hIgG1."

Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

DEM BioPharma Announces Poster Presentation Featuring DEM301 at the 2026 ASCO Gastrointestinal Cancers Symposium (Businesswire) - "The preclinical data to be presented at ASCO GI will highlight potent and durable single-agent anti-tumor efficacy in preclinical models of colorectal and other GI tumors and a favorable safety profile in a humanized DEM-TXX mouse model, supporting advancement toward clinical development. DEM Bio is currently advancing DEM301 through preclinical pharmacology and toxicology studies and has initiated CMC process development and manufacturing development in preparation for a planned Phase 1a/1b clinical trial expected to begin in the second half of 2026."

New P1 trial • Preclinical • Colorectal Cancer