Jan 23, 2026

Cantargia Reports First Patient Dosed in New US Investigator-Initiated Colorectal Cancer Study

Cantargia AB (Publ) (Nasdaq Stockholm: CANTA) today reported that the first patient has been dosed in a Phase 1b/2 clinical trial investigating nadunolimab in combination with checkpoint inhibitor therapy in up to 24 patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer (CRC). The study is an investigator-led initiative in collaboration with Dr. Dan Fang at Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York.

“Building on the exciting clinical results generated in patients with solid tumors and strong preclinical data, we look forward to providing nadunolimab for evaluation in this new patient group. We are excited that a high-profile center like the Tisch Cancer Institute views nadunolimab as a novel and promising therapy and are looking forward to offering patients this treatment option” said Hilde Steineger, CEO of Cantargia.

“Microsatellite stable colorectal cancer remains one of the most challenging solid tumors to treat with immunotherapy,” said Dr. Dan Fang, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai. “The scientific rationale for using a novel IL1RAP-targeting approach with nadunolimab is compelling, and we look forward to generating translational insights that could inform future immunotherapy strategies.”

Nadunolimab has been investigated by Cantargia in approximately 300 patients with solid tumor indications and has shown signals of clinical activity in pancreatic cancer and non-small cell lung carcinoma. Researchers at the Tisch Cancer Institute have a long-standing interest in developing new therapies for the treatment of CRC and have performed preclinical work strongly implicating IL-1 signaling in immune suppressive and treatment resistant pathways in this disease.

The new phase 1b/2a investigator-initiated trial will be conducted at Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. The study (NCT07281716), led by principal investigator Dr. Dan Feng, is designed to investigate nadunolimab in combination with an anti-PD-1 inhibitor in up to 24 patients with MSS CRC. In addition to investigating anticancer effects, the study will include a comprehensive biomarker assessment package.

About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia’s oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer and non-small cell lung cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia’s second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases. In September 2025, the acquisition of CAN10 by Otsuka Pharmaceutical was completed.

Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com.

About nadunolimab (CAN04)
Nadunolimab is an antibody that binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and the development of resistance to chemotherapy. Nadunolimab has been investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316, evaluated nadunolimab in combination with standard chemotherapies in patients with pancreatic ductal adenocarcinoma (PDAC) (gemcitabine/nab-paclitaxel) or non-small cell lung cancer (NSCLC) (platinum-based chemotherapies). Positive data show durable responses for combination therapy in 73 PDAC patients, resulting in a median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Intriguing efficacy was observed in a small group of non-squamous NSCLC patients post PD(L)-1 therapy.