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Cantargia treats first triple-negative breast cancer patient in randomized phase II part of TRIFOUR trial

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today reported that, following positive results in the lead-in phase of the clinical phase Ib/II trial TRIFOUR, the first triple-negative breast cancer (TNBC) patient has initiated treatment with the IL1RAP-binding antibody nadunolimab (CAN04) and chemotherapy in the phase II randomized part of the trial. Up to 98 patients may be included in this part and the next milestone, an interim futility analysis of 28 patients, is estimated in Q4 2023.

“We are proud to have started Cantargia’s first randomized trial with nadunolimab, in patients with triple-negative breast cancer, shortly after presenting an early signal of efficacy in this type of patients. This marks good progress as nadunolimab continues to demonstrate potential to make a significant difference in treatment of cancer,” said Göran Forsberg, CEO of Cantargia.

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The initial dose-escalation stage of TRIFOUR was recently finalized where an acceptable safety and early signs of efficacy were reported for the combination therapy. The preliminary response rate of 50%, including one complete response in 12 patients, indicates an improvement compared to historical control data for chemotherapy alone.

In the open-label phase II stage of TRIFOUR, first or second-line patients with advanced TNBC will be randomized in a 1:1 ratio to either a control arm where the chemotherapy doublet of gemcitabine and carboplatin is given alone, or an investigational therapy arm where nadunolimab is also administered. The primary objective is to investigate antitumor activity. The TRIFOUR trial is conducted in collaboration with the Spanish Breast Cancer Group (GEICAM).

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 main program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim 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, with initial focus on systemic sclerosis and myocarditis.

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

Founded in 1995, GEICAM is a non-profit organization leading academic breast cancer research in Spain. Today, GEICAM is comprised of more than 900 experts based over 200 Spanish hospitals, and has carried out over 100 studies involving more than 66,000 women and men. GEICAM’s mission is to promote independent clinical, epidemiological, and translational research in oncology, with a multidisciplinary approach and under quality criteria, to improve health outcomes, as well as prevention, medical education, and the dissemination of the knowledge of breast cancer to patients and general society.

More information about GEICAM is available at