Copyright © 2021. Inderes Oyj. All rights reserved.

Cantargia AB today announced that the first patient has received treatment with nadunolimab (CAN04) and FOLFIRINOX in the phase Ib study, CAPAFOUR, investigating treatment of patients with metastatic pancreatic cancer (PDAC). The study will include approximately 30 patients at multiple sites in France and Spain.

The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody CAN04 is Cantargia's most advanced program. The first patient has now been dosed in the phase Ib study CAPAFOUR, investigating CAN04 in combination with one of the two most commonly used first line chemotherapy regimens in metastatic PDAC, FOLFIRINOX. CAPAFOUR will be conducted at three sites in France and five sites in Spain. Approximately 30 patients are planned to be enrolled and recruitment is estimated to take 18-24 months.

CAN04 is currently evaluated in several clinical trials, including a phase I/IIa study, CANFOUR, which is examining first line combination with gemcitabine and nab-paclitaxel in patients with advanced PDAC, and gemcitabine and cisplatin in non-small cell lung cancer (NSCLC) (https://clinicaltrials.gov/ct2/show/NCT03267316). Additional clinical studies investigating CAN04 combination with chemotherapy for treatment of various forms of cancer will initiate during 2021. Further, CAN04 is evaluated in combination with a checkpoint inhibitor, pembrolizumab, in four different solid tumor indications in the phase Ib study CIRIFOUR (https://clinicaltrials.gov/ct2/show/NCT04452214).

The primary objective of CAPAFOUR is to assess the safety and tolerability of CAN04 combined with FOLFIRINOX. The patients will receive CAN04 and FOLFIRINOX for up to 12 cycles. The initial part of the study, a dose escalation phase with increasing doses of CAN04 in combination with FOLFIRINOX, will include up to 15 patients. The second part, an expansion phase, will explore the highest safe dose of CAN04 in up to 15 additional patients. Secondary endpoints include effects on serum biomarkers, such as IL-6 and CRP, biopsy analysis and antitumor efficacy. Additional trial details can be found on https://clinicaltrials.gov/ct2/show/NCT04990037.

"As Cantargia's vision is to provide cancer patients with novel treatments, the start of this trial is a moment of pride. Based on the synergies observed between CAN04 and platinum-based chemotherapy, we have high expectations on the outcome of this study.", said Göran Forsberg, CEO of Cantargia.

For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]

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 13.00 CET on 26 August 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 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 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 three ongoing clinical trials. In the first phase I/IIa-study, CANFOUR, first line combination therapy is investigated using two different standard chemotherapies in patients with NSCLC (gemcitabine/cisplatin) and 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 IL-6 and CRP decreased during treatment. Positive interim data from the combination therapies show durable responses or pseudoprogression in patients with PDAC, resulting in iPFS of 7.8 months, and also a higher response rate of patients with NSCLC, compared to chemotherapy alone. A phase I study, CAPAFOUR, was initiated in H1 2021 and will investigate CAN04 in combination with the chemotherapy regimen FOLFIRINOX for first line treatment of metastatic PDAC. A phase I study, CIRIFOUR, is also currently investigating CAN04 in combination with an immune checkpoint inhibitor and was started H2 2020 (https://clinicaltrials.gov/ct2/show/NCT04452214). Additional clinical combination studies are planned to start during 2021.

Cantargia AB is engaged in the development of products used in the treatment of cancer. It has developed specific antibodies against IL1RAP to treat serious, life-threatening diseases. The company's first product candidate, CAN04, has also been designed to treat different forms of cancer, with the initial focus on the treatment of non-small cell lung cancer and pancreatic cancer.