Mar 25, 2025

Cantargia publishes an abstract on parallel anti-tumor activity and reduction of chemotherapy-induced neuropathy with nadunolimab

Nadunolimab’s additional potential in mitigating neuropathy demonstrated by data from Cantargia’s CESTAFOUR and CAPAFOUR clinical studies

Potential neuroprotective effect further supported in preclinical models

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today announced the publication of an abstract on the American Association for Cancer Research (AACR) website highlighting the potential neuroprotective role of nadunolimab (CAN04) in addition to its reported anti-tumor benefits. The anti-tumor efficacy of nadunolimab in metastatic pancreatic cancer (PDAC) is strongly supported by the outcomes observed in the CANFOUR Phase 2 study (NCT03267316), where the 60% of patients that had high IL1RAP expression showed a 48% ORR and 14.2 months OS. Beyond tumor control, higher nadunolimab doses were associated with both a lower incidence and a delayed onset of chemotherapy-induced peripheral neuropathy (CIPN). This neuroprotective activity is now supported by data from two additional clinical studies. These findings strongly suggest that nadunolimab offers neuroprotective benefits in addition to therapeutic efficacy.

“We’re very encouraged by this potential additional benefit of nadunolimab in reducing the severity and occurrence of CIPN on top of its promising survival benefit. CIPN results in an additional burden for the patient to deal with, impacts their ability to continue treatment and often has a long-lasting negative effect on the patient’s quality of life. We very much look forward to future studies to confirm this dual benefit of nadunolimab, particularly for the treatment of PDAC.” said Dominique Tersago, Chief Medical Officer, Cantargia.

Standard-of-care cancer treatments such as chemotherapy and antibody-drug conjugates (ADCs) can trigger inflammatory signals that promote peripheral neuropathy, a major and limiting side effect of these treatments. CIPN both limits treatment and severely impacts quality of life for patients. Based on the clinical findings in CANFOUR, nadunolimab’s potential in counteracting neuropathy associated with chemotherapy was further investigated.

Nadunolimab’s potential to mitigate FOLFOX-induced CIPN was assessed among 14 patients across eight cancer types in the CESTAFOUR (NCT05116891) study. Patients treated with 1 mg/kg of nadunolimab experienced a significantly delayed onset (p=0.0004) and a lower incidence (43% vs. 100%) compared to the 0.5 mg/kg dose group. Similar trends of CIPN onset and incidence were observed in the CAPAFOUR (NCT04990037) study, where 18 PDAC patients received FOLFIRINOX in combination with escalating doses of nadunolimab (0.5–2.5 mg/kg).

Complementary preclinical studies showed that combining a nadunolimab surrogate antibody with various chemotherapy drugs completely inhibited CIPN in mouse models, highlighting IL1RAP-driven neuroinflammation as a potential underlying mechanism driving CIPN.

The preclinical data were generated in collaboration with Dr. Hana Starobova and colleagues University of Queensland, Australia. The abstract title and texts will be posted onto the AACR online itinerary planner for the upcoming annual meeting in Chicago, IL on Apr 25-30, 2025, which can be accessed through the conference website https://www.aacr.org./

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, non-small cell lung cancer and triple-negative breast 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, with 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 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 is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316, evaluates 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. Strong efficacy was also observed in 40 NSCLC patients with median PFS of 7.2 months and a response rate of 55%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase 1b/2 trial TRIFOUR, NCT05181462, also shows signs of promising efficacy in TNBC with a 60% response rate for nadunolimab combined with carboplatin/gemcitabine.