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

LUND, Sweden, March 14, 2023 /PRNewswire/ -- 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.

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).

For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: goran.forsberg@cantargia.com

This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 11.40  CET on 14 March 2023.

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 www.cantargia.com.

About GEICAM
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 www.geicam.org.

About nadunolimab (CAN04)
The antibody nadunolimab 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 development of resistance to chemotherapy. Nadunolimab is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR (NCT03267316) evaluates nadunolimab in combination with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) or NSCLC (cisplatin/gemcitabine). Positive interim data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median survival of 12.7 months. Strong efficacy was also observed in 30 NSCLC patients with median PFS of 6.8 months and a response rate of 53%; even higher responses were observed in non-squamous NSCLC patients previously treated with pembrolizumab. Early results from the phase Ib/II trial TRIFOUR (NCT05181462) also show signs of promising efficacy in TNBC with a 50% response rate for nadunolimab combined with carboplatin/gemcitabine. Nadunolimab is also investigated with chemotherapy in the clinical trials CAPAFOUR (NCT04990037) and CESTAFOUR (NCT05116891), and with the checkpoint inhibitor pembrolizumab in the CIRIFOUR trial (NCT04452214).

About TRIFOUR
TRIFOUR (NCT05181462) is a phase Ib/II clinical trial investigating nadunolimab (CAN04) in combination with the chemotherapy doublet carboplatin and gemcitabine for treatment of triple negative breast cancer (TNBC). TRIFOUR is performed at 24 clinical sites in Spain in collaboration with the Spanish Breast Cancer Group, GEICAM, and may include up to 113 patients. The phase I stage of TRIFOUR was recently finalized and acceptable safety and early signs of efficacy reported, including a preliminary response rate of 50%. TRIFOUR is now progressing to the randomized phase II stage where the primary objective is to determine antitumor activity. Various biomarker analyses will also be performed.

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