Sep 14, 2024 · Regulatory information

Cantargia presents positive results at ESMO Congress 2024 showing benefit of nadunolimab combination therapy in cancer after relapse on PD1-inhibitors

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today presented data from two clinical trials of nadunolimab combination therapy in 55 patients with primarily lung cancer and head and neck cancer. Both trials show e.g. very encouraging median survival times in patients previously treated with immunotherapy. These clinical data combined with baseline biopsy analyses suggest a unique role of nadunolimab acting on immunosuppressive cells in the tumor microenvironment.

“These new positive data presented at the ESMO conference, describe an important opportunity for nadunolimab in future clinical trials with potential to address a big unmet medical need” said Göran Forsberg, CEO of Cantargia.

The immunotherapy pembrolizumab, targeting PD1, is one of the most important cancer treatments with sales around US$ 25 B 2023. New data from two clinical trials in 55 patients highlight a unique opportunity using nadunolimab in patients after they have progressed on checkpoint inhibitors like pembrolizumab. A summary of the results based on the abstract submission in May 2024 was reported Sep 9, 2024, and updated results are described below.

The first trial, CANFOUR, investigated nadunolimab in combination with platinum doublet chemotherapy in 40 first- or second-line non-small cell lung cancer (NSCLC) patients. Stronger efficacy was seen in 2L pts (n=17) compared to 1L pts (n=23) (ORR 71% vs 44%; OS 15.7 vs 11.5 months). Biopsy analyses showed that the 2L pts had a higher number of IL1RAP-positive immune cells, CD163+ macrophages, CD56+ NK cells and CD8+ T cells in the tumor at baseline. Efficacy results were most pronounced in second line non-squamous pts (n=11; ORR 91%, OS 26.7 months; PFS 10.4 months) including two complete responders. The data suggest that nadunolimab may mediate its anti-tumor activity by blocking tumor promoting cells within the TME. The safety results of the combination have been presented previously and show an acceptable side effect profile.

The second trial, CIRIFOUR, investigated nadunolimab combination therapy with pembrolizumab in 15 heavily pretreated patients who had previously progressed on pembrolizumab or nivolumab monotherapy or combination treatments. Nine patients had head and neck cancer, 5 NSCLC and 1 melanoma. In this trial, the median survival was 19.7 months and the disease control rate was 60%. Similar to the CANFOUR data, the strongest benefits were observed in the group of patients with a specific profile of immune and immunosuppressive cells in the tumor microenvironment. The combination therapy was well tolerated.

The two posters are presented at the ESMO Congress 2024 in Barcelona on Saturday, September 14th by Dr Luis Paz-Ares, Hospital Universitario 12 de Octubre, Madrid, Spain and Dr Roger Cohen, University of Pennsylvania, Philadelphia, PA, US, respectively. The poster can be viewed on Cantargia’s webpage https://cantargia.com.

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 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 nadunolimab (CAN04)
The antibody nadunolimab binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1alpha and IL-1beta 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 (platinum-based chemotherapies). Positive interim data show durable responses for the combination therapy in 73 PDAC patients, resulting in 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 30 NSCLC patients with median PFS of 7.0 months and a response rate of 53%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase Ib/II trial TRIFOUR, NCT05181462, also shows signs of promising efficacy in TNBC with a 60% 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.