“It is most reassuring that the efficacy signals reported in a smaller group of pancreatic cancer patients are maintained in this significantly larger group. We are very eager to advance the development of nadunolimab in these patients in the phase II/III trial Precision Promise℠ in collaboration with PanCAN,” said Göran Forsberg, CEO of Cantargia.

CANFOUR (NCT03267316) is a combined phase I/IIa study where one objective is to evaluate nadunolimab, an antibody binding IL1RAP (Interleukin-1 Receptor Accessory Protein),  in combination with gemcitabine and nab-paclitaxel for treatment of first-line PDAC patients.

The extended interim analysis to be presented at ASCO 2022 adds data from 40 additional patients recruited between February to September 2021 to updated results from the initial group of 33 patients recruited earlier. Thus, the current update provides a much more robust analysis compared to previous analyses. OS and iPFS for the combination of nadunolimab with gemcitabine and nab-paclitaxel were well above historical values for chemotherapy only. Across the 73 patients, median OS was 12.7 months with 1-year survival of 57% and median iPFS of 7.2 months. Historical data for first-line treatment of PDAC with gemcitabine and nab-paclitaxel alone show median OS of 8.5 months with 1-year survival of 35% and median PFS of 5.5 months¹. The overall response rate (iORR) for nadunolimab combined with gemcitabine and nab-paclitaxel was 33% which is higher than previous analyses. Additionally, disease control rate was 73%, median duration of response 6.5 months and median duration of treatment 5.5 months. Twelve patients were still receiving treatment at data cut-off.

The safety profile of the nadunolimab combination was similar to that of chemotherapy alone. The ASCO 2022 data illustrate that neutropenia and febrile neutropenia, which were more frequent than expected from the chemotherapy primarily during the first cycle, could be managed by the granulocyte growth factor, G-CSF: with G-CSF prophylaxis, only 14% of patients developed grade 3-4 neutropenia, compared to 78% without prophylactic G-CSF. Notably, the incidence of neuropathy was much lower than expected for chemotherapy alone¹, a potential reflection of nadunolimab’s mechanism of action. In the current interim analysis, the incidence of grade 3-4 neuropathy was only 1%, compared to 17% previously reported for chemotherapy alone¹.

Biomarker studies in tumor biopsies and blood samples provided support for nadunolimab’s proposed mechanism of action. Presence of IL1RAP, the target of nadunolimab, was confirmed in the tumor tissue, as well as the tumor-promoting molecule IL-1α, which signals via IL1RAP. Furthermore, low baseline serum levels of CRP and IL-6, biomarkers relevant for the mechanism of action of nadunolimab and disease progression, correlated with better OS outcomes.

These data are based on a CANFOUR read-out conducted in April 2022 and will be presented in a poster discussion session at ASCO 2022. An abstract based on earlier data from January 2022 has now been published on the ASCO website (www.asco.org/abstracts). The poster will also be available at the Cantargia website (www.cantargia.com/en/research-development/publications) following the presentation.

Abstract Number and Title: #4141 Phase 1/2a trial of nadunolimab, a first-in-class fully humanized monoclonal antibody against IL1RAP, in combination with gemcitabine and nab-paclitaxel (GN) in patients with pancreatic adenocarcinoma (PDAC)
Session: Poster Discussion Session, Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: Saturday, June 4, 2022, 1:15 PM-2:45 PM; 8:00 AM-11:00 AM CDT
Presenter: Prof. Dr. Eric Van Cutsem

References
¹Von Hoff et al, N Engl J Med 2013; 369:1691-1703

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 23.00 CET on 26 May 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 in 73 patients with PDAC, resulting in median iPFS of 7.2 months and median survival of 12.7 months. Stronger efficacy was also observed in 30 NSCLC patients with median PFS of 6.8 months. A response rate of 53% was achieved, with even higher responses in non-squamous NSCLC 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).