Apr 21, 2023 · Regulatory information

Cantargia reports favorable safety of new nadunolimab combination therapy and completes enrollment in non-small cell lung cancer trial

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today announced a successful safety review of the ten non-squamous non-small cell lung cancer (NSCLC) patients treated with its lead asset nadunolimab (CAN04) and carboplatin/pemetrexed in the phase I/IIa CANFOUR trial. Enrollment to this trial has now ended; continued development of nadunolimab in NSCLC will further focus on patient subgroups by implementation of a biomarker strategy to identify best responders. Subgroup analyses will be based on efficacy and biomarker data from these ten patients as well as the 30 NSCLC patients previously treated with combination therapy in CANFOUR.

“The results generated in non-small cell lung cancer indicate promising treatment effects of nadunolimab in combination with existing therapies. Based on our new strong data in pancreatic cancer, in the context of the highly competitive lung cancer market, it is logical to apply a more focused strategy aiming for a large treatment benefit in a subgroup of patients,” said Göran Forsberg, CEO of Cantargia.

Nadunolimab has demonstrated promising clinical efficacy and good safety in combination with chemotherapy in patients with pancreatic cancer (PDAC), triple-negative breast cancer or NSCLC. Tumor and blood biomarkers from over 40 NSCLC patients will be evaluated during 2023 with the goal of identifying subgroups with the best responses to guide further clinical development steps in this indication. This is similar to the recent progress of nadunolimab in PDAC and is intended to maximize the potential of nadunolimab in NSCLC and increase the likelihood of success for the program.

Competition in the lung cancer market has greatly intensified over recent years due to changes in standard treatment strategies and an increased number of clinical trials. Consequently, recruitment of lung cancer patients to clinical trials has become even more challenging and there is a general need for more personalized treatment strategies and patient segmentation.

Promising interim efficacy has been shown for the 30 first- or second-line NSCLC patients treated with nadunolimab and cisplatin/gemcitabine in the CANFOUR trial; the strongest responses were observed in the non-squamous subtype with a higher response rate and longer duration of response than expected for chemotherapy alone based on historical data. Ten additional non-squamous NSCLC patients were treated with nadunolimab and carboplatin/pemetrexed and enrollment to CANFOUR has now been concluded following a successful safety review. The combination was generally well tolerated and no new side effects except those expected from chemotherapy or nadunolimab alone were observed. Updated safety and efficacy data from the NSCLC patients in CANFOUR will be presented at a conference in Q2 2023. Additional NSCLC patients in the third-line or beyond have been treated with nadunolimab and chemotherapy in the CESTAFOUR trial. NSCLC patients also received nadunolimab in combination with Keytruda® in the CIRIFOUR trial.

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. The 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 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 evaluates nadunolimab in combination with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) or NSCLC (cisplatin/gemcitabine) (NCT03267316). 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 12.9 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 6.8 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 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).