Cantargia submits application to start new clinical trial investigating antibody CAN04 and FOLFIRINOX in pancreatic can

STOCKHOLM, March 10, 2021 /PRNewswire/ -- Cantargia AB today announced the submission of a clinical trial application investigating antibody CAN04 in combination with FOLFIRINOX for first line treatment of metastatic pancreatic cancer (PDAC). The trial is designed to complement the ongoing clinical program and subsequently broaden the development of CAN04. The phase Ib trial is planned to be performed in up to 30 patients in France and Spain. The current estimate is to start therapy in the first patient in the end of Q2 2021.

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 advanced non-small cell lung cancer (NSCLC) or PDAC (https://clinicaltrials.gov/ct2/show/NCT03267316) in the first line chemotherapy setting. A second trial investigates CAN04 in combination with pembrolizumab in four different solid tumor indications (https://clinicaltrials.gov/ct2/show/NCT04452214).

The clinical trial application for a third study has now been submitted. It investigates CAN04 in combination with FOLFIRINOX treatment, one of the two most commonly used first line chemotherapies in PDAC. The design of the trial is based on the preclinical and clinical information generated so far. This includes the positive interim results using CAN04 in first line combination with gemcitabine and nab-paclitaxel in patients with advanced PDAC as well as with gemcitabine and cisplatin in NSCLC. Furthermore, preclinical models have shown synergy between CAN04 and oxaliplatin, being an active component of FOLFIRINOX. In the initial part of the trial, different dose levels of CAN04 in combination with the FOLFIRINOX regime will be investigated followed by expansion of the number of patients at the highest safe dose level. The trial will include up to 30 first line patients with PDAC and is planned to be carried out in France and Spain. Trial details will be disclosed on clinicaltrials.gov during Q2 2021.

"This is an important clinical trial which follows our commitment to provide large groups of cancer patients with novel, safe and efficacious treatment options. The starting point for the trial relates both to current knowledge on the IL-1 system's role in pancreatic cancer development and the potential for CAN04 to potentiate platinum-based chemotherapy", says Göran Forsberg, CEO of Cantargia.

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 08.30 CET on 10 March 2021.

About Cantargia

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.

About CAN04

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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