STOCKHOLM, Feb. 10, 2021
STOCKHOLM, Feb. 10, 2021 /PRNewswire/ -- Cantargia AB today announced that the first patient with pancreatic cancer (PDAC) has started treatment in the phase IIa extension part of the CANFOUR trial, investigating combination of CAN04 and chemotherapy. The extension part has been designed to provide additional information complementing the primary cohort of 31 patients. Nine of these patients are still being treated, providing additional information on long term efficacy and safety. Important efficacy parameters such as progression free survival and duration of response are planned to be evaluated for the primary cohort during H1 2021 for presentation at a scientific conference.
Cantargia develops antibody-based pharmaceuticals against interleukin-1 receptor accessory protein (IL1RAP). The antibody CAN04 binds IL1RAP with high affinity and functions through both blockade of IL-1 signaling and Antibody-Dependent Cellular Cytotoxicity (ADCC). Preclinical data show that CAN04 can increase the efficacy of chemotherapy. CAN04 is investigated in an open label phase I/IIa clinical trial, CANFOUR, examining combination with two different frequently used chemotherapy regimes in patients with non-small cell lung cancer (NSCLC) or PDAC (https://clinicaltrials.gov/ct2/show/NCT03267316) in the first line chemotherapy setting.
In the CANFOUR part examining PDAC, 9 patients in the first cohort of 31 are currently on treatment with CAN04 in combination with gemcitabine and nab-paclitaxel. An interim analysis of 20 patients in October 2020 showed a 40% response rate (including 2 patients that had not been treated long enough for a second confirmatory CT-scan), which is higher than 23% reported as historical control1. The efficacy and safety results from the 31 patients are planned to be presented at a scientific conference and will also include other important effect parameters evaluated during H1 2021 such as progression free survival, duration of response and biomarkers.
In parallel to documenting these long-term efficacy parameters, Cantargia will, as previously communicated, study additional patients in a phase IIa extension phase. A few different dose levels will be investigated to get robust data on relationships between dose, efficacy and safety. Also, the screening procedures have been simplified, shortening the time frame from screening to first chemotherapy dose e g by not requesting biopsies prior to treatment. The first patient in this phase has started treatment and the plan is recruit 20-40 patients over 6 months. In parallel with the ongoing clinical studies, upcoming development activities of CAN04 are being implemented in accordance with previous communications, including preparations of the planned interactions with major regulatory authorities.
"The CANFOUR trial is progressing well and we are very pleased to have started the phase IIa extension cohort. With long term data from the first group of 31 patients together with interim data from the extension, we expect to have a robust data set to discuss with regulatory authorities before late stage clinical trials", says Göran Forsberg, CEO of Cantargia.
1 Von Hoff et al, N Engl J Med 2013; 369: 1691-703
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
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 13.30 CET on 10 February 2021.
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases. The basis for this is the protein IL1RAP that is involved in a number of diseases and where Cantargia has established a platform. The main project, the antibody CAN04, is being studied clinically as combination therapy 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 show a higher response rate 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.
The antibody CAN04 binds strongly to the target IL1RAP and functions both though ADCC as well as 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 two clinical trials. In the first phase I/IIa-study, CANFOUR, first line combination therapy is investigated using two different standard chemotherapies in 31 patients with NSCLC (gemcitabine/cisplatin) and 31 patients with PDAC (gemcitabine/nab-paclitaxel), as well as monotherapy in late stage patients (https://clinicaltrials.gov/ct2/show/NCT03267316). Phase I monotherapy data from 22 patients were presented at ASCO 2019 and showed good safety with infusion related reaction being the most common side effect. In addition, the biomarkers IL6 and CRP decreased during treatment. Positive interim data from the combination arms was presented during H2 2020 and showed a higher response rate than expected from chemotherapy alone. A phase I study investigating CAN04 in combination with an immune checkpoint inhibitor started H2 2020 (https://clinicaltrials.gov/ct2/show/NCT04452214). Additional clinical combination studies are planned to start during 2021.
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