Cantargia reports treatment of first non-squamous non-small cell lung cancer patient in new arm of CANFOUR study

Cantargia AB today reported that the first patient in the new non-squamous non-small cell lung cancer (NSCLC) therapy arm of the CANFOUR study has received treatment with nadunolimab and chemotherapy. Interim clinical data has shown encouraging efficacy in patients with non-squamous histology, the largest NSCLC subgroup. Up to 40 patients will be treated with nadunolimab and carboplatin/pemetrexed and recruitment is expected to take 12-15 months. In parallel, preparations are ongoing for a randomized trial in this patient group with an anticipated start in early 2023.

Nadunolimab, an antibody binding interleukin-1 receptor accessory protein (IL1RAP) is Cantargia’s most advanced program and is investigated in multiple clinical trials. CANFOUR, the first clinical trial for nadunolimab, is a combined phase I/IIa study (NCT03267316). The current focus of CANFOUR is to evaluate nadunolimab in combination with chemotherapy regimens for treatment of pancreatic cancer and NSCLC. Recently, an additional arm was included in CANFOUR where nadunolimab is evaluated with platinum-based chemotherapy, carboplatin/pemetrexed, in first line chemotherapy treatment of non-squamous NSCLC, the most common form of lung cancer. The first patient in this arm has now received treatment.

Initially, a run-in phase is performed to document the safety of different dose levels of nadunolimab in combination with standard doses of carboplatin/pemetrexed. Combination with the highest safe dose of nadunolimab will subsequently be evaluated with the objective to confirm safety and assess antitumor activity and effects on biomarkers. Patient recruitment will be performed in seven countries in Europe and is expected to take up to 12-15 months.

“The results obtained to date with nadunolimab combination therapy for non-squamous NSCLC are truly promising and we are therefore excited to have started treatment of patients in the next phase of the development,” said Göran Forsberg, CEO of Cantargia.

Preclinical results have shown that nadunolimab can potentiate chemotherapy. To date, more than 100 patients have been treated with such combinations with encouraging results. At the recent ESMO Congress, Cantargia presented positive interim efficacy data based on 27 NSCLC patients treated with nadunolimab and chemotherapy in CANFOUR (Awada et al). Based on these results, the next steps in the development within NSCLC will focus on the non-squamous form, while development in the squamous form will be performed separately.

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 09.00 CET on 4 February 2022.

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 project, the antibody nadunolimab, is being studied clinically in combination with chemotherapy or immune therapy with a primary focus on non-small cell lung cancer and pancreatic cancer. Positive interim data from the combination with chemotherapy indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia’s second project, the antibody CAN10, 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 CAN04 binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Thereby, CAN04 can counteract the contribution of the IL-1 system to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. CAN04 is investigated in multiple ongoing clinical trials. In the phase I/IIa study CANFOUR, first line combination therapy is investigated with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) and patients with NSCLC (cisplatin/gemcitabine) (NCT03267316). Positive interim data for the combination therapies show durable responses or pseudoprogression in patients with PDAC, resulting in median iPFS of 7.2 months and median survival of 12.7 months. Stronger efficacy was also observed in NSCLC patients with median PFS of 7.2 months. A response rate of 53% was observed in non-squamous NSCLC patients, with even higher responses in patients previously treated with pembrolizumab. These results show stronger efficacy than expected from chemotherapy alone. CAN04 is investigated with chemotherapy also in the phase I study CAPAFOUR, with the FOLFIRINOX regimen for first line treatment of metastatic PDAC (NCT04990037), and in two further clinical studies, CESTAFOUR (NCT05116891) and TRIFOUR (NCT05181462), in additional forms of cancer, including biliary tact cancer, colorectal cancer and triple negative breast cancer. CAN04 is also evaluated with the immune checkpoint inhibitor pembrolizumab, with or without chemotherapy, in the phase I study CIRIFOUR (NCT04452214).

---