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Cantargia: ASCO 2022 presentation strengthens positive phase IIa interim results for nadunolimab in NSCLC

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Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today reported updated interim results for non-small cell lung cancer (NSCLC) patients treated with nadunolimab (CAN04) in combination with gemcitabine and cisplatin, showing efficacy well above historical controls. With 30 patients evaluable, overall response rate (ORR) was 53%, disease control rate 83%, median progression-free survival (PFS) 6.8 months and median overall survival (OS) 13.7 months. The strongest efficacy benefits were seen in patients with non-squamous NSCLC, particularly those treated previously with a checkpoint inhibitor. The safety profile was acceptable and in line with earlier data. The results will be presented at the ASCO 2022 Annual Meeting on 6 June 2022.

“This updated and matured data set reinforces previously reported positive results for nadunolimab combination therapy in NSCLC and supports our understanding how our antibody works. This strengthens Cantargia’s strategic focus in lung cancer, and we are currently planning the next steps in the development of nadunolimab in a randomized trial in non-squamous NSCLC,” said Göran Forsberg, CEO of Cantargia.

In total, 33 NSCLC patients were included in the phase IIa part of the CANFOUR trial, of which 30 received treatment with 1, 2.5 or 5 mg/kg of Cantargia’s IL1RAP-binding antibody, nadunolimab, in combination with gemcitabine and cisplatin. Efficacy analyses across all 30 patients treated with the combination showed an ORR of 53%, which is well above historical data of 22-28% for chemotherapy only1. Additionally, disease control rate was 83%, median PFS was 6.8 months and median OS was 13.7 months. PFS and OS were stronger than historical data which show a median PFS and OS of 5.1 months and 10.3 months, respectively2. The last patient in the trial started treatment in September 2021. At data cut-off in April 2022, seven patients were still being treated, with one patient on therapy for over 30 months.

The strongest clinical benefit was observed in the 16 patients with non-squamous NSCLC, with an ORR of 56% and median PFS of 7.3 months. The effect in this subgroup was much stronger than for chemotherapy only, which shows 19% ORR and median PFS of 4.9 months3. Notably, an even higher ORR of 88% was observed in the eight non-squamous patients previously treated with pembrolizumab. Data on subgroup OS is still maturing.

Efficacy parameter according to RECIST1.1 All (n=30)* Non-squamous (n=16) Squamous (n=13)
ORR 53% 56% 46%
Disease control rate** 83% 75% 92%
Median duration of response 5.8 months 11.2 months 4.1 months
Median PFS 6.8 months 7.3 months 5.8 months
Median OS 13.7 months*** NA NA
*One tumor of unknown histology **Two patients with non-squamous NSCLC withdrew early in association with COVID-19  ***Based on 37% of events

The safety profile of the combination was acceptable and readily managed. Rates of neutropenia and febrile neutropenia were more frequent primarily during the first cycle compared to historical data for chemotherapy alone2, but could be reduced by the granulocyte growth factor, G-CSF: only 33% of patients treated prophylactically with G-CSF developed grade 3-4 neutropenia, a level similar to chemotherapy alone, compared to 71% without prophylactic G-CSF. Thrombocytopenia and grade 1-2 infusion-related reactions following the first infusion were also more common compared to chemotherapy only. The infusion-related reactions could be efficiently managed by standard measures.

Notably, increased levels of both IL1RAP and IL-1α were observed in tumor biopsies following four weeks of treatment, potentially due to induction of the danger signal IL-1α by chemotherapy, in line with previous preclinical observations. IL-1 signaling is implicated in chemoresistance and blockade of this signaling by nadunolimab may sensitize tumors to chemotherapy. Additionally, treatment with nadunolimab reduced serum levels of the biomarkers CRP, IL-6 and IL-8, relevant for disease progression, further supporting a beneficial effect through blockade of IL1RAP.

These data are based on a 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: #9020 Phase 1/2a trial of nadunolimab, a first-in-class fully humanized monoclonal antibody against IL1RAP, in combination with cisplatin and gemcitabine (CG) in patients with non-small cell lung cancer (NSCLC)
Session: Poster Discussion Session, Lung Cancer – Non-Small Cell Metastatic
Session Date and Time: Monday, June 6, 2022, 1:15 PM-2:45 PM; 8:00 AM-11:00 AM CDT
Presenter: Luis Paz-Ares

1Schiller et al, N Engl J Med 2002; 346:92–98
2Scagliotti et al, J Clin Oncol 2008; 26:3543–3551
3Gandhi et al, N Engl J Med 2018; 378:2078-2092

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).