Cantargia's Nadunolimab Antibody Awarded Fast Track Designation by FDA

June 11, 2025 - Cantargia (Cantargia AB (publ); NASDAQ Stockholm: CANTA), today announced that the U.S. Food and Drug Administration (FDA) has granted nadunolimab, Cantargia's anti-IL1RAP antibody, Fast Track Designation (FTD) for the treatment of patients with previously untreated metastatic pancreatic ductal carcinoma (PDAC) with high IL1RAP expression in combination with gemcitabine and nab-paclitaxel. The Fast Track designation is based on strong clinical data from the CANFOUR study showing a 2-year survival of 35%, an overall survival (OS) of 14.2 months and an overall response rate (ORR) of 48% in this patient population.

“This recognition from the FDA for our clinical and translational data for nadunolimab and the future path forward in pancreatic cancer is an outstanding development for Cantargia. The FDA’s support for the continued development of nadunolimab in the group of PDAC patients with high IL1RAP expression further strengthens our efforts to offer this potentially important new treatment to these patients who currently lack options,” said Damian Marron, CEO of Cantargia.

Fast Track Designation is a tool and process designed by the FDA to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The goal is to get important new drugs to patients faster. The benefits of FTD include:

• More frequent meetings and communication with the FDA.
• Possibility of Accelerated Approval and Priority Review , if relevant criteria are met.
• Rolling Review with the ability to submit completed portions of a Biologic License Application (BLA) for review by the FDA, rather than waiting until the entire BLA is completed ¹ .

Nadunolimab, a fully humanized Fc-enhanced IgG1 monoclonal antibody targeting IL1RAP, is being developed as a treatment for PDAC, a serious and life-threatening malignant tumor of the pancreas. The prognosis for metastatic PDAC is consistently poor. Treatment options are limited and overall survival (OS) after first-line therapy for metastatic PDAC is <12 months. The 5-year survival probability is <5% for metastatic disease, and the prognosis has not improved significantly over the past 20 years. High tumor expression of IL1RAP, the target of nadunolimab, is associated with shorter survival ² .

In the phase II CANFOUR study, IL1RAP protein expression was measured in tumor biopsies by immunohistochemistry from a total of 49 patients. It is worth noting that the subgroup of patients with high baseline IL1RAP expression achieved a significantly higher treatment effect than patients with low baseline expression: median OS 14.2 vs. 10.6 months (p=0.012), median PFS 7.4 vs. 5.1 (p=0.012) months and ORR 48% vs. 30% (p=0.205) ³ . The 2-year survival rate in patients with high IL1RAP was 35%.

Cantargia is currently preparing for the next step in clinical development by developing a diagnostic test to identify patients with high IL1RAP expression for inclusion in future clinical studies.

References:

1. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
2. Hansen et al, Journal for ImmunoTherapy of Cancer (2024) - Blocking IL1RAP on cancer-associated fibroblasts in pancreatic ductal adenocarcinoma suppresses IL-1 induced neutrophil recruitment
3. van Cutsem et al, Clinical Cancer Research (2024) - Efficacy and Safety of the Anti-IL1RAP Antibody Nadunolimab (CAN04) in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Advanced/Metastatic Pancreatic Cancer

About Cantargia
Cantargia AB (publ), corporate registration number 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 several cancers and inflammatory diseases. Cantargia's oncology project, 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 results for the combinations indicate a higher effect than expected with chemotherapy alone. Cantargia's other development project, the antibody CAN10, has a different profile for blocking signaling via IL1RAP compared to nadunolimab and is optimized for the treatment of serious autoimmune/inflammatory diseases, with an initial focus on hidradenitis suppurativa and systemic sclerosis.

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

About nadunolimab (CAN04)
The antibody nadunolimab binds strongly to its target molecule IL1RAP and works by inducing ADCC and blocking IL-1α and IL-1β signaling. Nadunolimab can thus counteract the IL-1 system that contributes to an immunosuppressive tumor microenvironment and resistance to chemotherapy. Nadunolimab is being investigated in several ongoing clinical trials; the phase I/IIa CANFOUR trial, NCT03267316 , is investigating nadunolimab in combination with standard chemotherapy in patients with pancreatic ductal carcinoma (PDAC) (gemcitabine/nab-paclitaxel) or non-small cell lung cancer (NSCLC) (platinum-based chemotherapy). Positive data show long-term responses to combination therapy in 73 PDAC patients, resulting in a median iPFS of 7.2 months and a median OS of 13.2 months. Even longer median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Strong efficacy was also observed in 40 NSCLC patients with a median PFS of 7.2 months and a response rate of 55%; even higher responses were noted in patients with non-squamous NSCLC. Early results from the phase Ib/II TRIFOUR trial, NCT05181462 , also show promising efficacy in TNBC with a 60% response rate for nadunolimab in combination with carboplatin/gemcitabine.