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Cantargia AB today announced that the development of nadunolimab (CAN04) has been broadened following the submission of an application of a phase I/II clinical trial to evaluate combination with chemotherapy in three different forms of solid tumors. Thus, the development of CAN04 is expanded to biliary tract cancer (BTC) and colorectal cancer (CRC), and extended to new patient populations in non-small cell lung cancer (NSCLC). The study, called CESTAFOUR, will be conducted at approximately 20 clinical centres in Europe. The first patient is estimated to be enrolled in September 2021.

The antibody CAN04, binding to interleukin-1 receptor accessory protein (IL1RAP), is Cantargia's most advanced program and is investigated in multiple clinical trials. CANFOUR, a phase I/IIa trial, investigates CAN04 first line combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer (PDAC), as well as with gemcitabine and cisplatin in NSCLC (https://clinicaltrials.gov/ct2/show/NCT03267316). In the phase Ib trial CAPAFOUR, CAN04 is also evaluated for treatment of metastatic PDAC in combination with the first line chemotherapy option FOLFIRINOX. Additionally, CAN04 is investigated in a phase Ib trial, CIRIFOUR, in combination with the checkpoint inhibitor pembrolizumab in four different forms of solid tumors (https://clinicaltrials.gov/ct2/show/NCT04452214).

The clinical trial application for a fourth study, called CESTAFOUR, has now been submitted. This is an open label phase I/II clinical trial, which will evaluate CAN04 in combination with chemotherapy frequently used for treatment of three forms of solid tumors. This includes first line treatment of advanced BTC in combination with gemcitabine and cisplatin, CRC in combination with FOLFOX as third line therapy, and NSCLC in combination with docetaxel as second or third line therapy. The format originates from a basket-like design with selected combinations based on previous preclinical and clinical data for CAN04. A cornerstone in the trial is the previously reported synergy between CAN04 and platinum-based chemotherapy. The basket-like design also creates an opportunity for broadening the program into new diseases, such as BTC and CRC, where platinum-based chemotherapy is routinely used. Furthermore, broadening to a later stage patient group in NSCLC is based on previously communicated positive results in this disease. With an expected median survival of less than a year, the medical need in each of the chosen patient segments is very high.

In the initial dose escalation phase, performed in approximately 15 patients for each indication/combination, the primary objective is to assess the safety and tolerability of CAN04, in combination with each of the three chemotherapy regimens. In the phase II part, the primary objective is to assess the antitumor efficacy. The phase II part will include approximately 40 patients for each of the three indications. The phase I part of the study will be performed in France, Spain and the United Kingdom and the first patient is estimated to be enrolled in September 2021. Trial details will be disclosed on clinicaltrials.gov during Q3 2021.

"Based on the intriguing synergies with chemotherapy, the potential for CAN04 could be very high and exploring new opportunities is of great strategic value. We are really pleased to reach this development milestone.", 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 14.00 CET on 29 June 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 two 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 IL6 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, CIRIFOUR, 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.

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.